Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

Continuing the 510(k) premarket notifications list, 1000 records per page.

  1. K210256CiRx (R) Surgical Mask
  2. K252514EVAC-MRI
  3. K003283SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
  4. K061424CELSITE/ CELSITE CONCEPT, ACCESS PORTS
  5. K210089CATSmart, Automated Blood Processing Autotransfusion System
  6. K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
  7. K932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE
  8. K153658Target Detachable Coils
  9. K854118DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS
  10. K973980ACU-STIM TENS, AP-101082T
  11. K123675RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS…
  12. K921155O.R./SURGEONS GOWN, ITEM NO. 4962
  13. K892079CHAMP-PAQ VINYL PATIENT EXAM GLOVES
  14. K253254GBT Machine Airflow Prophylaxis Master
  15. K952690EMG DISC RECORDING ELECTRODE WITH PIN
  16. K792363SILAGUM
  17. K032852MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
  18. K012945SYNTHES 2.4 MM CANNULATED SCREW
  19. K013807MICROJET QUARK, MODEL U100 OR U40
  20. K910927SPENCIO SKIN GUARD KIT
  21. K110039BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
  22. K942980ARGESOL #615
  23. K212860SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P…
  24. K231834VSP PEEK Cranial Implant
  25. K850736SELECTIVE CULTURE MEDIUM
  26. K001374PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT
  27. K990745MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM
  28. K192984APTUS Clavicle System
  29. K011658CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS
  30. K980005MANAN D BAG
  31. K912600INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER
  32. K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLE
  33. K954264ACI SINGLE LUMEN BIOPSY NEEDLE
  34. K982467CAPIOX CARDIOPLEGIA
  35. K170949RadiForce MX315W
  36. K103033TRABECULAR METAL FUSION DEVICE MODEL 06-101-XXXXX, 06-102-XXXXX AND 08-100-XXXXX
  37. K152230Ebony PTA .014 RX Pheripheral Dilatation Catheter
  38. K895805SLIDEX ROTA-KIT 2
  39. K251923Medical Shaver System (Morcellator) (YSB-IIIA)
  40. K201734AllerBlock Junior
  41. K031427ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1
  42. K113779CONELOG IMPLANT SYSTEM
  43. K091658GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100…
  44. K811973FORDER RETRACTOR
  45. K250083PRO-DOSE System
  46. K230565HILINE™ Fixation System
  47. K041639TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM
  48. K897128UMI BRAIDED CATHETER CONNECTOR
  49. K203499Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
  50. K972429INNERWEAR, GENTLEMEN'S CHOICE W/NONOXYNOL-9
  51. K872859ACE CANCELLOUS BONE SCREW
  52. K924383SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO
  53. K860298STABLELINE
  54. K801552MOD. 9542 FLOW-THRU INJECT. TEMP. SENSOR
  55. K841756LIEBEL-FLARSHEIM ACS 1000 CHEST X-RAY
  56. K930843RAPID DISCONNECT Y-SET, CAT. NO. 48-7000
  57. K151027zensor system
  58. K980821HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
  59. K160591D.O.R.C. Disposable Cryo Probe
  60. K900758HEPARINIZED ARTERIAL SCREEN BLOOD FILTER
  61. K924297DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER
  62. K871961MULTIPLE SPECTACLE LENS
  63. K250279RC-SwiftPrep
  64. K102709PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE
  65. K071325BIOMET VARIABLE LOCKING PLATE SYSTEM
  66. K920003DRG CEMETED STEM
  67. K961076MM 324
  68. K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
  69. K152001Sterile Repositionable Hemostasis Clipping Device
  70. K043273LIGASURE VESSEL SEALING SYSTEM. LIGASURE INSTRUMENTS
  71. K831511TRACHEOSTOMY TUBE
  72. K023132JOSTRA MECC SYSTEM
  73. K071884BODY COMPOSITION ANALYZER, MODELS: X-SCAN PLUS II, GAIA 359 PLUS, PLUSAVIS 333, XBIA 500…
  74. K250760SPECTRUM GV Bone Cement
  75. K800084RITTER MODEL J DENTAL CHAIR
  76. K942553GENESIS
  77. K183126Electrosurgical accessory
  78. K123430MICROSLIDER TEARAWAY INTRODUCER SET
  79. K140985SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
  80. K102575ORTHO MTA (MINERAL TRIOXIDE AGGREGATE)
  81. K880179BEAVERS' DENTAL DIAMOND INSTRUMENTS
  82. K910502VESSEL DILATORS
  83. K121198BW685, BW685S
  84. K220171NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter
  85. K871423PHENYTOIN FPIA CALIBRATORS
  86. K112533ZAVATION CERVICAL PLATE SYSTEM
  87. K913024ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
  88. K182472Cepheid Xpert GBS LB Control Panel
  89. K220901S-Core Implant System
  90. K191089Edwards Pressure Cable
  91. K080364FINDRWIRZ GUIDE WIRE SYSTEM
  92. K024134UNI HIP STEM
  93. K945593SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
  94. K192125Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
  95. K981660Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
  96. K850200SUCTION REGULATOR 7700 SERIES
  97. K250034Natural rubber latex male condom
  98. K893464VARIAN MULTILEAF COLLIMATOR
  99. K900970RADIATION PROTECTION GLASSES
  100. K913324MITYVAC(R) SAFTISOFT OBSTETRICAL VACUUM DELIV KIT
  101. K123556MORTARA SURVEYOR PATIENT MONITOR
  102. K834298UNICONDYLAR FIBER METAL KNEE
  103. K062923MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML)
  104. K112454HALO60 ABLATION CATHETER
  105. K812041VENTI-MONITOR MODEL 101
  106. K092910FLUID-FILLED TEETHER
  107. K860132AIR CARE AIR SANITIZER
  108. K022972MICROFILL 13
  109. K201840Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)
  110. K060874DEPUY GLOBAL AP SHOULDER SYSTEM
  111. K993628OMNISONICS ULTRASONIC PROBES
  112. K002638FUTURE DIAGNOSTICS B.V. STAT-ACTH KIT
  113. K772340CATHETERIZATION KIT 732016-732018
  114. K800600B-D STASET, I.V. FLOW CONTROLLER
  115. K120897PROGRIP LAPARSCOPIC SELF-FIXATING MESH
  116. K030958ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
  117. K801357MODIFIED BLOOD CELL COUNTING & LYSING
  118. K031043D-10 HEMOGLOBIN A1C
  119. K062085S4 SPINAL SYSTEM
  120. K012205GLUCOMETER DEX TEST SENSOR
  121. K991647TFX MEDICAL INTRODUCER KIT
  122. K080553DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
  123. K992884WHEELCHAIR (MANUAL, NOT ELECTRICAL)
  124. K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph
  125. K990142HT, MODEL HT PB
  126. K100810ELECSYS C-PEPTIDE CALCHECK 5
  127. K874135CONDOM (PROPHYLACTIC)
  128. K792190MODEL CF-300 THREE CHANNEL FLOW METER
  129. K791930IV EXTENSION SET SL
  130. K770174LUER-LOCK EXTENSION SET
  131. K973693AQUA PATCH
  132. K111913CAPSURE(R) PS SYSTEM
  133. K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT
  134. K112707GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
  135. K142223Pilot Pro Diode Laser
  136. K162247PERMATAPE
  137. K991457DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE
  138. K800551TRIGLYCERIDES TEST (500NM)
  139. K896606JACKSON FINE NEEDLE ASPIRATION SYSTEM
  140. K192854MammoScreen
  141. K092683DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LD 1143
  142. K920193OMNIFLEX M-HA HIP STEM SERIES
  143. K021241SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
  144. K891781TOXO ELISA TEST SYSTEM
  145. K060410ECHOHEART TRANSVAGINAL DOPPLER PROBE
  146. K002278BROOKER FEMORAL NAILS
  147. K150239FibroScan
  148. K003941ELECSYS HCG STAT CLASET II
  149. K974183POLYMER NITRILE EXAMINATION GLOVES (BLUE COLOUR)
  150. K830306HEARTRATE PLUS ECG CARDULE #1918
  151. K970979LIQUID CSF(LCR)1, LIQUID CSF(LCR)2
  152. K003345AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
  153. K981424NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
  154. K892542RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
  155. K150823EDLENi Intra-Oral Sensor
  156. K040038CURVED CUTTER STAPLER, MODELS CS40B, CS40G; RELOAD FOR CURVED STAPLER, MODELS CR40B, CR40G
  157. K870046DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
  158. K031521AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
  159. K161483Unger Quad Injector
  160. K072026RNK ELECTRONIC STETHOSCOPE
  161. K820472WILLIAM HARVEY H-625 ARTERIAL FILTER
  162. K965101CARDIOBEEPER CB-12L
  163. K153636Liberator Powered Wheelchair with Solar Companion
  164. K212069Corin MetaFix™ Hip Stem
  165. K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
  166. K251526FilmArray GI Control Panel M238
  167. K915525WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
  168. K001486GENX CODA AIR PURIFICATION SYSTEM
  169. K9639208 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
  170. K173923Temporary Cardiac Pacing Wire
  171. K030048HA PMI FEMORAL HIP STEM
  172. K791529INFUSION NEEDLE SET
  173. K911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWERED
  174. K221019Osteon Precision Milled Suprastructure
  175. K980773ETEST GREPAFLOXACIN
  176. K931474DRUG, INSURANCE, URINALYSIS, BLOOD/URINE TEST KITS
  177. K090104LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603
  178. K042293BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
  179. K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment
  180. K862800SMX GENERATOR
  181. K190515Aptima Combo 2 Assay (Panther System)
  182. K042536MASIMO SET RAD 57 PULSE CO-OXIMETER
  183. K191482Senhance Surgical System
  184. K760997UNDER BOTTOCKS DRAPE
  185. K943003CALCIUM QVET
  186. K891884PATIENT EXAMINATION GLOVES (LATEX)
  187. BK050071Test, Qualitative, for HLA, Non-Diagnostic
  188. K032138MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL…
  189. K091346CODMAN HAKIM MICRO II VALVE
  190. K121747FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS
  191. K002715ECAT PET SCANNER
  192. K042170EN-BLOC BIOPSY SYSTEM MODEL#777-110,777-001,777-002,777-006,777-301,777-302,777-115,777-12…
  193. K944948FREE-LANCE
  194. K132390INSTINCT; PLAIN, DOTTED, ULTRA THIN
  195. K963824LI'S ITCH STOPPER
  196. K971943MYRINGOTOMY TUBE
  197. K946285COPAN VENTURI TRANSYSTEM STUARTS MEDIUM
  198. K852637THERMO TRIM
  199. K842836SAFE & SOFT MINI PADS & MAXI PADS
  200. K891147PATIENT EXAMINATION GLOVE (LATEX)
  201. K090917SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
  202. K191052HyaloGYN Vaginal Moisturizing Suppositories
  203. K955597MEDI-TRACE DEFIB PADS
  204. K151962KBL Sunlamp Products (= Device Bundling name)
  205. K955487GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
  206. K842304THE PATHFINDER
  207. K780102ULTRAZYME PLUS GPT
  208. K920299MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT
  209. K913234VPW2906A1: 480V, 3 PHASE, X-RAY POWER SUPPLY
  210. K070095TRIATHLON TS KNEE SYSTEM
  211. K882383MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES
  212. K961209BRIO AUTOMATIC SAMPLINC UNIT
  213. K092143EXCIA TOTAL HIP SYSTEM M AN ML FEMORAL STEM
  214. K954163RETROSPECTIVE II-ELITE ECG MEMORY LOOP RECORDER
  215. K914940BELTONE CLEARVOICE
  216. K191616Orthophos S
  217. K990606TETRAFILCON A
  218. K102153MOBIUS ULTRASOUND IMAGING SYSTEM
  219. K8707097.5 MHZ ENDOVAGINAL PROBE
  220. K791049SYNALON ROLLER BOTTLE
  221. K181566Nutrifill
  222. K151715T3 Software
  223. K843873LEUKOFIX R
  224. K934694KIRSCHNER ZIRCONIA FEMORAL HEAD
  225. K972671BUN (LIQUID) REAGENT SET
  226. K231340Renova Spine Balloon Catheter
  227. K874837KTP/532 LASER FOR OB-GYN USE
  228. K802452TOXOTEST-MT EIKEN KIT
  229. K142090REBOSSIS
  230. K120515TEMPUS CERVICAL PLATE SYSTEM
  231. K191640TK Intravascular Administration Set
  232. K092902U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE…
  233. K840711PULMONARY FUNCTION SYS-3000
  234. K914706FO51/F151 GOLF MASSAGER
  235. K152371Vantage Titan 3T
  236. K931986AMP ALKALINE PHOSPHATASE REAGENT KIT
  237. K060701BISCEM TRANSLUCENT, BISCEM OPAQUE
  238. K810073MARK 500 SYSTEM
  239. K031760VIEWPOINT TELEMETRY SYSTEM
  240. K024082HEMOSIL FACTOR VII DEFICIENT PLASMA
  241. K925980PM
  242. K030880VECTORSONIC, MODEL VU-270
  243. K823636ARM THROUGH FOR WHEELCHAIR BK-6459-01 &
  244. K032666MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
  245. K222813Nitrile Examination Gloves
  246. K953291QUANTA LITE ACA SCREEN (HRP)
  247. K981461GC FUJI ORTHO LC
  248. K892320PATIENT EXAM GLOVES (LATEX)
  249. K871185LITHIUM INTERNAL STANDARD 1 MEQ/L #60085
  250. K883779WALLABY(TM) BLANKET
  251. K943869ULTIMAX (GREEN POWDER FREE EXAMINATION)
  252. K897046LASER RESISTANT TRACHEAL TUBE
  253. K242152SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
  254. K982707EC6 PLETHYSMOGRAPH
  255. K982786TRACCELL 2000 SLIDE MAPPING SYSTEM
  256. K082650SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL
  257. K211897Surgical Face Mask
  258. K904553BONE STAPLE(S)
  259. K981869PRO-FLEX DISPOSABLE PROPHY ANGLE
  260. K964441FEMRX FOCUSED MONOPOLAR (FAP) OPERASTAR SYSTEM [OUTPATIENT ENDOSCOPIC RESECTION AND…
  261. K080851A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
  262. K201928e-Ortho Shoulder Software
  263. K102771BIOPSY HANDY, MRI BIOPSY HANDY
  264. K942147PACIFIC COMMUNICATIONS MODEL 1100
  265. K963094CYNOSURE PHOTOGENICA LP DERMATOLOGICAL VASCULAR LESION LASER
  266. K894916COMFEEL TRANSPARENT DRESSING
  267. K260564DESS Dental Smart Solutions
  268. K904330TURBO-RAST SPECIFIC IGE ASSAY
  269. K923881QUADRATURE CERVICAL CONTOUR COIL
  270. K894631NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW.
  271. K974142HM-RUBY
  272. K912903PERCUTANEOUS RETRACTOR KIT
  273. K203125Invictus™ OCT Spinal Fixation System
  274. K923435CORNEAL TOPOGRAPHY SYSTEM
  275. BK980025Blood Establishment Computer Software and Accessories
  276. K812599MEDTRONIC #4951
  277. K895519SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD
  278. K061060TT101, MODELS TT 101-1,-2,-3,-4,-5,-6,-7,-8
  279. K150389Spiral Flow Peripheral Vascular Graft
  280. K914314FORTEX(TM) WOUND DRESSING
  281. BK100033System, Test, Automated Blood Grouping and Antibody
  282. K924405CONTROL PLASMA P
  283. K013220HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY…
  284. K942381LOW PRESSURE INJECTION TUBING, COILED LINE, EXTENSION TUBING
  285. K870348NORFLOXACIN 10 MCG SENSITIVITY DISKS
  286. K032267R&D DESIGNATION AP-052-5
  287. K874857KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0
  288. K874825DISPOSABLE CAUTERIES
  289. K223008Disposable Vinyl Examination Gloves
  290. K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM
  291. K090119SICAT IMPLANT
  292. K863028ROSSTEC IMPLANT SYSTEM FOR EDOSTEAL IMPLANTOLOGY
  293. K831459FETAL BLOOD SAMPLING KIT #1560
  294. K880650HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
  295. K042444LITESTREAM 500E
  296. K991858SSA-390A/POWER VISION 8000
  297. K942346IMAGERT
  298. K151116CapLOX II/TowerLOX Pedicle Screw System
  299. K223538Integrity Implant
  300. K123651CINCHLOCK KNOTLESS SUTURE ANCHOR
  301. K981244BW-1 (CODE NAME RD-0807)
  302. K003261CREATININE PLUS
  303. K952038CLEAN-CUFF
  304. K770091EMERGENCY FAST-FIX DENTURE REPAIR KIT
  305. K851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
  306. K881676LINEAR LIFT DEVICE
  307. K050800NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS
  308. K031287STERI-DRAPE SURGICAL DRAPES
  309. K905830COMBO FETAL SCALP ELECTRODE/LEGPLATE
  310. K772387LEAD HAND
  311. K203799ProFlex CO2 Laser Fiber
  312. K120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEM
  313. K981951CT 100 ELECTROCARDIOGRAPH
  314. K970931COPALIS TORC TOTAL ANTIBODY ASSAY
  315. K935753THE GRAFTOLOGER
  316. K772027CARDIOCASSETTE II
  317. K802526TEST KIT FOR DETECTION OF HERPES SIMPLEX
  318. K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
  319. K894296PREMISE SERIES BED
  320. K872005MAXIMUM, LATEX PROPHYLACTIC BRAND
  321. K063471SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHITE) VINYL PATIENT…
  322. K122132AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE)…
  323. K780046ULTRASPHYG BLOOD PRESSURE OPTION
  324. K262983EsTemp Implant
  325. K791589G N BROTH HAJNA
  326. K191537eCarbon IBDs
  327. K972332AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM
  328. K922694KINETIC TECHNOLOGY PRECISION ADUSTOR MODEL SHLCP-4
  329. K212916Black Nitrile Powder Free Patient Examination Glove, Non Sterile
  330. K122237BIOPHOTAS LIFELIGHT
  331. K843266ID ZONE NORMAL LD ISOENZYME CONTROL
  332. K040216CERASORB M ORTHO
  333. K231381Xpert Xpress MVP; GeneXpert Xpress System
  334. K840116DESERET INFANT CENTRAL VENOUS CATHE-
  335. K831406RESTROSPECTIVE ECG MEMORY MODULE
  336. K761207HEMATRAK RBC MORPHOLOGY
  337. K781093HDL CENTRIFIKIT
  338. K870018E-Z JECT INSULIN SYRINGE
  339. K210239CITRESPLINE and CITRELOCK ACL Implants
  340. K875159DETECTADOT SYSTEM 2000 CMV IGG TEST
  341. K201723F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
  342. K042192LOW FLOW OSV II HYDROCEPHALUS VALVE
  343. K935034LASER GAS MIXTURE
  344. K242726Synapsys VHIT
  345. K990052TEL-ECHO SYSTEM
  346. K896191SUNTANNING BED, INC. T12 UVA TANNING LAMPS
  347. K073272WORKSTATIONONE BREAST IMAGING WORKSTATION
  348. K020202PLAYTEX DEODORANT TAMPONS, MODEL 34702
  349. K932345TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE
  350. K914739ASL MODEL #102
  351. K812331VTS-1000 VISUAL TESTING SYSTEM
  352. K852953#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
  353. K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE
  354. K914111METAL URETERAL BASKET STONE DISLODGER, HELICAL
  355. K051060ANGIODYNAMICS PROFILER PTA BALLOON CATHETER
  356. K812195EMIT-ST CANNABINOID ASSAY
  357. K181971Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
  358. K801531ARM SLING
  359. K953951WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR
  360. K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
  361. K960451WEBB-MORLEY SPINE SYSTEM
  362. K202876Confirm Rx Insertable Cardiac Monitor
  363. K790559ALARM
  364. K945838CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY
  365. K852596A-COMPANY ELASTIC LIGATURE RINGS
  366. K141620RS80A DIAGNOSTIC ULTRASOUND SYSTEM
  367. K073534CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
  368. K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
  369. K011785NOVEL PRINT CYAN ALGINATES
  370. K141520ALERE I INFLUENZA A & B
  371. K850496TRANSPORT INCUBATOR 185
  372. K013983WIENER LAB. ALP 405
  373. K943961THE MODEL ACAPPELLA IN THE EAR HEARING AID
  374. K213935PISCES-SA Standalone ALIF Interbody System
  375. K850483MICRO-AIRE STERNUM SAW REPLACEMENT BLADES
  376. K100761BIOPRO POLAR HEAD
  377. K051663MALIBU SPINAL SYSTEM
  378. K043292HEMOCATH
  379. K191389Allcem Veneer APS
  380. K181001Medtronic Confida Brecker Guidewire
  381. K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…
  382. K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
  383. K853785SERIES 2000 MEDS MASK
  384. K953423CASRRASYN ORAL WOUND DRESSING
  385. K202662Parcus Titanium Interference Screws
  386. K954688FLOW-COUNT COULTER FLUOROSPHERES
  387. K894918HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
  388. K800605ANA LATEX SLIDE TEST
  389. K112587ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,
  390. K021518PAINDOC
  391. K912142MICRONAIRE ISO-HOOD MAX 5UV
  392. K183469Microlife Digital Blood Pressure Monitor
  393. K925355BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST
  394. K993310APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH
  395. K844149AMBU RUBEN CIRCLE ANESTHESIA SYSTEM
  396. K150986Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants
  397. K862622I22 CITE
  398. K780372CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS.
  399. K153089'cottony' II TAPE, PLEDGETS
  400. K853429COULTER COUNTER MODEL M5
  401. K062295IRI INTEGRATED RETINAL IMAGER
  402. K022433NEOGENESYS 2K
  403. K930275PRECISION OSTEOLOCK ACETABULAR COMPONENT
  404. K063704BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
  405. K111546U2 HIP SYSTEM
  406. K972060NASAL SEPTAL BUTTON
  407. K984270VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000
  408. K131959HEINE MINI 3000(R) OPHTHALMOSCOPE
  409. K895903IVT 0.014 GUIDE WIRE
  410. K193385TP Orthodontics Clear Aligner System
  411. K971994B-D ASSURE EAR THERMOMETER
  412. K221501syngo.via View&GO
  413. K121282MICROLUX/DL MICROLUX/BLU BIO/SCREEN
  414. K781759RESCAL
  415. K972202DEEG-LITE
  416. K052549LEADCARE II BLOOD LEAD TESTING SYSTEM
  417. K932180EYE SPOT CRP TEST
  418. BK860031Supplies, Blood-Bank
  419. K885085ERGOMED 840/ERGOMED 840L
  420. K822888OHIO CPU-1 INTENSIVE CARE VENTILATOR
  421. K903199HOLLOW LUMEN NEEDLE, PART NUMBER: MX920
  422. K905426AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE
  423. K012088NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
  424. K090762LEDA
  425. K912660SECURODRIP
  426. K781259VENTILATION TUBE TEFLON SHEPARD TYPE
  427. K874382RAICHEM(TM) ALCOHOL REAGENT
  428. K032013COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
  429. K021220NITRILE PATIENT EXAMINATION GLOVE POWDER-FREE (BLUE COLOR) TESTED FOR USE WITH…
  430. K802287RIGHT ATRIAL LINE KIT
  431. K895204EPI-CATH(TM) EPIDURAL CATHETER
  432. K943024KINASE ISOENZYME
  433. K933366I.V. LINK
  434. K130027DISPOSABLE NEUTRAL ELECTRODE GP202
  435. K882807DULBECCO'S MODIFIED EAGLE'S MEDIUM NO. 200-2011
  436. K864807TEKNAR PROSCAN(TM)
  437. K142881DMRC Dual Cure Orthodontic Band Cement
  438. K871891KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER
  439. K884612FRANKLIN COLLECTOR(R)
  440. K051209LEVITRONIX CENTRIMAG BACK-UP CONSOLE
  441. K210948Omnilux CLEAR
  442. K821907NEIDENT*
  443. K801624SHARPLAN 723 CO2 LASER SURGICAL SYSTEM
  444. K990960PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
  445. K040581MEDVIZERTM VITELCARE PATIENT MONITORING SYSTEM
  446. K023702POWDER-FREE NITRILE EXAM GLOVES, COLOR: BLUE
  447. K150311Full Automatic (NIBP)Blood Pressure Monitor
  448. K864162DEGUPAL
  449. K884120TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
  450. K091922WATERLASE C100, MODEL 7100104
  451. K981235OCULOSTAT
  452. K214077Digital Thermometer, Model: DT007, DT008
  453. K932745C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)
  454. K111778JBAIDS INFLUENZA A SUBTYPING KIT
  455. K802881ABSELE* ABSORBABLE BONE SEALANT
  456. K781255DIGITAL PANEL METER
  457. K182224SafeAir Smoke Evacuator compact
  458. K933883GAMBRO FH 66 D HEMOFILTER
  459. K823442FISCH MODIFIED TOTAL OSSICULAR PROSTHES
  460. K992442V.T.S., INC. (V.T.-3)
  461. K962360IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
  462. K012175PASS SPINAL SYSTEM
  463. K942210PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
  464. K073119CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
  465. K895527THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM
  466. K761314FLEXION-BRAKING KNEE-SHIN ASSEMBLY
  467. K841303CAMPYLOBACTER THIOGLYCOLLATE MED
  468. K050470CONCENTRIC EMBOLIC PEARLS
  469. K933311MOTORIZED ELECTRIC PARALLEL BARS
  470. BK150302Test, Qualitative, for HLA, Non-Diagnostic
  471. K874547KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED
  472. K792245TEETH, DENTURE, PLASTIC
  473. K924013MACAW
  474. K830311AUTO STIK
  475. K884654ALPHACALF SERUM
  476. K980018CRISTOBAL
  477. K141973DIODE LASER HAIR REMOVAL SYSTEM
  478. K973913MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
  479. K904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATION
  480. K162774MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP…
  481. K063677FUSION QUATTRO EXTRACTION BALLOON XL
  482. K993982SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL
  483. K011181ICS MEDICAL CHARTR OAE WITH TYMP
  484. K884053PRN PLUS + INFUSION SET
  485. K895587CROSS MEDICAL PRODUCT PEDICLE AWL
  486. K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…
  487. K211035U9000 Plus Ultrafilter
  488. K895032ZOLL PD 2200 PACING-DEFIBRILLATION ELECTRODES
  489. K913644VITA IN-CERAM
  490. K260326Giraffe™ OmniBed™ Carestation (CS1); Giraffe™ Incubator Carestation (CS1)
  491. K080115I-MINI DENTAL IMPLANT
  492. K802091AMERICAN MONITOR MAGNESIUM #'S 1036&4021
  493. K212274INT Contour
  494. K940104OTOSONIC MINI PAS
  495. K961221PYLORI IGG ELISA TEST SYSTEM
  496. K915207DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
  497. K971425NARKOMED M ANESTHESIA SYSTEM (M)
  498. K122131POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
  499. K003085CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
  500. K251530CONMED Argo Knotless® Anchor
  501. K053475OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450
  502. K965127DGH MODEL 9000
  503. K210392WorkMate Claris System
  504. K191330Arc Enterocuff
  505. K802263MINIVISOR TERMINAL
  506. K041869SELF RETAINING BICANALICULUS INTUBATION SET
  507. K113823HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
  508. K910026ATI MEDICAL COMFORT PLUS CPM PAD
  509. K192936Soltus 500
  510. K021270ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-2
  511. K023785LUNG NODULE ASSESSMENT AND COMPARISON OPTION
  512. K943236OPTILINE, CARLO BELLINI, EXPLOREFLEX, STRATFORD & TITINIFLEX
  513. K840605LABORIE FIBREOPTIC LIGHT CABLE
  514. K884976MICRO-STRAIGHT POSTURE TRAINING DEVICE
  515. K022993HOVEROUND REHAB SEATING SYSTEM FOR POWER WHEELCHAIRS
  516. K955035VIDAMED SERIES 7205 ELECTROSURGICAL GENERATOR
  517. K212777Collaboration Live
  518. K090714VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
  519. K930765ULTRA COMPACT VIDEO IMAGER
  520. K070775MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM
  521. K952338STA-COAG CONTROL [P] PLUS KIT
  522. K041092FAST START TENS, MODEL FS 3001
  523. K792383KELMAN DIPSTICK
  524. K001284STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
  525. K000583FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
  526. K112005NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING…
  527. K930558MORTARA INSTRUMENT, INC. E-SCRIBE
  528. K170954Portable ECG Monitor
  529. K962133EXPANDACELL INJECTO-PAK
  530. K011376EVERGREEN AND MULTIPLE PRIVATE LABELS NON-STERILE POWDERED LATEX PATIENT EXAMINATION…
  531. K231631BriefCase-Quantification
  532. K924380MDT/HARVEY MODEL 7000 & 8000 CHEMICLAVE
  533. K112339ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
  534. K780716TECHNICON BGII ANALYZER
  535. K182070BioHorizons Tapered IM Implants
  536. K921017HARGIS SR2 SELF-RETRACTION SYSTEM
  537. K013291ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM)
  538. K143559XP1000 RF
  539. K854567PENICILLIN/STREPTOMYCIN SOLUTION
  540. K032543SIRONA DENTAL SYSTEMS C8+DENTAL OPERATIVE UNIT WITH ACCESSORIES
  541. K941649SURGICAL SPONGE
  542. K0117666F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR…
  543. K853798BONE IMPACTORS
  544. K981981ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT)…
  545. K101993VIPER SYSTEM, EXPEDIUM SYSTEM
  546. K823683VITALOGRAPH PFT PRINTER
  547. K943291ANTI DS-DNA
  548. K801019125I-IGE RADIOIMMUNOASSAY KIT
  549. K093646DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
  550. K090256POWER STANDING DANI
  551. K870406SMI DIGITRON
  552. K0026796060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351
  553. K232519ENDOCOLLECT Specimen Retrieval Bag
  554. K243189TumorSight Viz
  555. K770548IMMUNOPLATE III RADIO IMMUNODIFFUSION
  556. K823286MODELS DPT 1000/DPT 1000NS
  557. K042855INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT
  558. K983289APOLIPOPROTEIN A1
  559. BK180232Blood Establishment Computer Software and Accessories
  560. K832047STERILE SUTURE REMOVAL SET
  561. K211816Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with…
  562. K897050WILSON-COOK LUNG BIOPSY NEEDLE
  563. K974363BECTON DICKINSON BLUNT PLASTIC CANNULA
  564. K143668Navio
  565. K923792QUANTEC SPINAL MEASUEMENT SYSTEM
  566. K920025OLYMPUS DISPOSABLE SUCTION VALVE
  567. K120491DSS STABILIZATION SYSTEM-RIGID
  568. K202128Allmed Surgical Face Masks (Ear loops)
  569. K781042PROLITH 23S PACEMAKER
  570. K972227SHOE COVER
  571. K141067VIVID T8/VIVID T8 PRO
  572. K130735SYNTHETIC ABSORBABLE SUTURE
  573. K190963DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional
  574. K862236MYOLAB II, MODEL ML-200
  575. K953972ANGIOVISION VIEWING STATION
  576. K233846Vitrification Solution Set and Warming Solution Set
  577. K872355COLIN'S MODEL APBM-630 AND QUINTON'S MODEL 470
  578. K880529CEILING MOUNTED TILTING TABLE TANGENT III
  579. K923924VOICEWAVE
  580. K944863COMPEL SURGICALDRAPES
  581. K873858AMERLITE TT3 ASSAY, LAN.0003/1003/2003
  582. K033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
  583. K943084SPECTACLE FRAME
  584. K063511CERAMILL ZI
  585. K014261ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
  586. K011486Q-RAD RADIOGRAPHIC SYSTEM
  587. K841610COMPONENTS FOR POTASSIUM, SODIUM CHLO
  588. K904540VIDEO SYSTEM INTERFACE MODELS
  589. K000516GE LOGIQ 700
  590. K833681POROCOAT HPS II HIP PROSTHESIS
  591. K881274CENTER BEND ARCH WIRES
  592. K000870KM-10 TENS ELECTRODE
  593. K915471CRYOBAG
  594. K000172DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS
  595. K913192SIMULTEST(TM) IMK-LYMPHOCYTE
  596. K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
  597. K831286ULTIPORE PREBYPASS PLUS FILTER
  598. K191266VitalScan ANS
  599. K993522AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT
  600. K042825ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM
  601. K012448VECTORVISION TRAUMA
  602. K810467EMIT-ST SERUM ETHYL ALCOHOL ASSAY
  603. K935766PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS
  604. K930080E*NET NEUROMONITORING SYSTEM
  605. K001616MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
  606. K120492K2 MEDICAL VASCULAR CLAMPS
  607. K760257SPONGE, RICHARDS WOUND DRAINAGE SYSTEM
  608. K033542EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
  609. K153220syngo.CT Single Source Dual Energy (Twin Beam)
  610. K090109BLOOD GAS, ELECTROLYTE AND METABOLITE TEST CARD
  611. K260289Perfect-O Ostial Positioning Catheter
  612. K113342SOMATOM DEFINITION FLASH
  613. K212653Catalyft LS Expandable Interbody System
  614. K070245CAPSURE PEDICLE SCREW SYSTEM
  615. K790031GENERATOR, BIOTEC 876 PULSE
  616. K832086USE 77 ULTRASONIC NEBULIZER
  617. K042839C-PET PLUS IMAGING SYSTEM
  618. K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS
  619. K810439BODY STRAP
  620. K790535CLAYTON COLON CLEANSING KIT
  621. K211335Diode Laser Machine, Model Number: BM-100
  622. K962183BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER…
  623. K221745Sterile Posterior Spinal Fixation System
  624. K201042PROBEAT-CR
  625. K993029ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS; MODELS 1E09 AND 6E89
  626. K936287KODAK SURECELL HCG URINE TEST, MODIFICATION
  627. K201272Geneva
  628. K162817Noddle(TM)
  629. K982203CAAS II LVA BIPLANE OPTION
  630. K013007BELLEGLASS HP ENAMEL 2
  631. K791412DISPOSABLE INSTRUMENT TRAY PAD
  632. K874296INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER
  633. K991203IRRIGATION OR INFUSION PUMP K PUMP
  634. K211938Physica LMC Knee System
  635. K870181JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
  636. K934175STRETCHPOWER(TM) BRAND OF STRETCH LOADING EXERCISER
  637. K163531Advanced Perfusion System 1
  638. K080200WATER WORKS DOUCHING DEVICE
  639. K896800IRRIGATION TRAY
  640. K770307MICRO/PETTOR, SMI
  641. K101465STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR
  642. K031256XSIF-1TQ140A SMALL INTESTINAL VIDEOSCOPE
  643. K113363ANGIOJET SOLENT DISTA THROMBECTOMY SET
  644. K251096PeekMed web
  645. K954500HOSPITEC MEDI-BUTLER
  646. K991229K-SYSTEMS WORK STATIONS, TYPE L-13W, L-13E, L-13ES, L-13ET, L-13EM, L-23, L-23E, L-24…
  647. K000568HDL CHOLESTEROL PLUS
  648. K964387POINT OF USE II SHARPS-A-GATOR
  649. K941664SHARP DISPOSAL CONTAINERS WALL SAFE
  650. K253559Ventana™ A Anterior Lumbar Interbody System
  651. K123370EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC…
  652. K153612ArthrexVIP Web Portal
  653. K905095MODEL 3100-21: QUADRATURE SPINE COIL
  654. K172711Comet-PLUS
  655. K812064POLI-AXIAL KNEE CAGE
  656. K082545STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
  657. K221979Pulse Oximeter (Model C101A2, C101B1, C101A3)
  658. K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
  659. K951260URINARY INTERMITTENT CATHETERS W/O HYDROMER HYDROPHILIC LUBRICANT
  660. K935645FLOWGUN REUSABLE IRRIGATION PROBES
  661. K122554GENASIS SCANVIEW SYSTEM
  662. K163148BePOD® Foot Screws
  663. K0709512CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND…
  664. K993540ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
  665. K830180REFEREE BRAND CO-OXIMETER REAGENTS
  666. K221333Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
  667. K080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
  668. K070881LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
  669. K955354ALTERNATIVE STERILIZATION PROCESS
  670. K202377Palm Care Latex Examination Powder Free Gloves
  671. K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…
  672. K823873CHAIN SILENCER
  673. K242258MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)
  674. K192845Sperm Freeze, Sperm Fridge
  675. K904639GENOX MODEL CT-1
  676. K112896ARRW EVOLUTION
  677. K984136BARDEX LUBRI-SIL I.C. FOLEY CATHETER
  678. K111694ASTRA
  679. K040071ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND…
  680. K914760LATEX EXAMINATION GLOVES
  681. K961873ACTIVENT ANTIMICROBIAL VENTILATION TUBES
  682. K040253EASY MED TN-28 C
  683. K823920COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
  684. K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
  685. K852595DC-3 FLUIDS PACK, DC-5 FLUIDS PACK
  686. K052690SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
  687. K160096InZone Detachment System
  688. K232413Fusion Robotic Navigation System
  689. K822381SYVA LAB PROCESSOR 6000
  690. K853709A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM
  691. K790554EXETER LIP SEAL
  692. K230438URIS Smart Path Implant System & Prosthetic
  693. K945940COATEST(R) APC(TM) RESISTANCE
  694. K030261BATTERY, RECHARGEABLE
  695. K130501INTENSIF
  696. K230409Wrist Type Blood Pressure Monitor (W05,W1101L)
  697. K926481VALLEYLAB MODEL E252OH, FORCE GSU(TM) HANDSET
  698. K981394BRAEMAR ER700 SERIES AMBULATORY ECG EVENT MONITOR MODELS ER710,ER720
  699. K030246VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
  700. K870053TORQUEDRIVER WRENCH
  701. K1829581.5T 16ch Breast Coil
  702. K093629SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM
  703. K223709Kyphoplasty Balloon Catheter
  704. K852410MEVAPLAN AND SOMADOS
  705. K082173Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
  706. K813104POWER DRIVE WHEELCR
  707. K844818NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
  708. K821851CONTROL DIAGNOSTICS PLATELET CONTROL
  709. K964174MINERAL TRIOXIDE AGGREGATE (MTA)
  710. K896906LATEXINDO LATEX EXAMINATION GLOVES
  711. K980318POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
  712. K132496ARTHROSURFACE TOEMOTION
  713. K020683ISOROD PD-103 IMPLANT, MODEL ATI-PD-103
  714. K896070PFEIFFER METERED DOSAGE SYSTEM
  715. K983184MEPILEX
  716. K061789LATERAL PLATE SYSTEM
  717. K914820DSL INSULIN RIA (DSL 1600)
  718. K984043QUADRANT TOTAL ETCH
  719. K992835C.S.O. TONOMETER
  720. K000426VIP- VARIABLE INTENSITY POLYMERIZER
  721. K934042CHEMSTRIP SUPER UA URINE ANALYZER
  722. K153188Caremed patient cable and leadwires
  723. K905838STRATO PORT INTRODUCER KT(10 FR) LPS 5015/MODIFIED
  724. K023700PVS 1600 SYNCHRO 0.010 NEURO GUIDE WIRE
  725. K941465SUTURE REMOVAL KIT
  726. K193060Noritake Super Porcelain EX-3
  727. K240247“MoFi” Cell Culture Basal Medium
  728. K960503DANTEC DUET
  729. K791774LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN
  730. K9027287.5 MHZ BI PLANE RECTAL PROBE (P/N: 041-815)
  731. K894256STERILE SURGEONS GLOVES
  732. K252297Toro 88 Superbore Catheter
  733. K141699VASSEN COLOR
  734. K781639SHILEY CRICOTHYROTOMY TUBE
  735. K051223HIPSTAR FEMORAL STEM
  736. K092521ZUMA-C
  737. K960229RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM
  738. K160814Sydney IVF Sperm Cryopreservation Buffer
  739. K251652Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA…
  740. K801496PULMONARY LAB AUTOMATION SYSTEM
  741. K003709SURGICAL DYNAMICS MESH CAGE SYSTEM
  742. K072764KLS MARTIN XTERNAL FIXATOR
  743. K132572I-HIP TOTAL HIP SYSTEM
  744. K791662IMMUCHEM COVALENT COAT BINDING
  745. K800567RADIOEAR MODEL RM-L & RM-C HEARING AID
  746. K110369INDISTRIP GREEN
  747. K081379MODIFICATION TO INREACH SYSTEM
  748. K132887AIRFIT N10
  749. K050606SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)
  750. K063719ARTHREX CROSSPIN, MODEL AR-1964P
  751. K041287VILEX BONE PLATE SYSTEM
  752. K884686VAPAMASTA 5
  753. K970847IMPULSE HVG
  754. K972955PALCERAM 56
  755. K111353ACCU-CHECK COMBO SYSTEM
  756. K801009HOWMEDICA WHITE C&B ALLOY
  757. K912441LINEARITY TEST KITS
  758. K190124EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One
  759. K983580BLASTOCYST MEDIUM
  760. K951713BUTTON LUBRICATOR
  761. K895430HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100
  762. K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
  763. K112842AMS ELEVATE PC
  764. K090403AUTOSPECT
  765. K001052MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
  766. K101867VICOR PD2I ANALYZER
  767. K812932ANERIOD GAUZE
  768. K934914ICS 9400 ULTRAVIOLET AIR PURIFIER
  769. K090218MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
  770. K062660CATALYSY
  771. K010096MULTI CARE THERAPEUTIC VIBRATOR
  772. K972144SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
  773. K261025Wearable breast pump (QY-101, QY-102, QY-108)
  774. K113822QUADRASPHERE 30 TO 60
  775. K841980SIDE CUTTING SERRATED BLADE
  776. K142783HEARTWAY Electrically Powered Wheelchair P27
  777. K842436ERIKA NEGATIVE PRESS. ARTERIAL BLOOD
  778. K070464ONDEMAND3D
  779. K936161SYSTEM, X-RAY, MAMOGRAPHIC
  780. K823589H 12 07
  781. K992045ELECTROSURGICAL ELECTRODE FAMILY
  782. K963061IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
  783. K960518THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM
  784. BK160035Test, Qualitative, for HLA, Non-Diagnostic
  785. K020813BACT/ALERT FA CULTURE BOTTLE
  786. K120548HLIC NEEDLE-LESS VALVE
  787. K113739SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
  788. K963685EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
  789. K900799COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS
  790. K142572Zimmer Zfx Abutment for Zimmer 3.1mmD Implant System
  791. K892279PATIENT EXAMINATION GLOVES
  792. K771014TS-100 TEST SYSTEM
  793. K181047Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with…
  794. K200848Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
  795. K901558GIOTTO MAMMOGRAPHY HF
  796. K892750PATIENT EXAMINATION GLOVES (LATEX)
  797. K955727BAND-IT 20CC DRIVER/ 15 MIN 20CC ADMINISTRATION SET
  798. K953849PRISM ELECTROSCOPE
  799. K061913IBA PROTON THERAPY SYSTEM - PROTEUS 235
  800. K963433THREADED FIXATION PIN
  801. K112205SNORERX 9.0
  802. K781794BETA-TEC
  803. K954866MERCURY CPR (COMPLETE PERSONAL RESUSCIATOR) BAG WITH EXPANDABLE RESERVOIR
  804. K905271PRIDE SPIRIT
  805. K844510OMS SCISSORS
  806. K963315VINGMED SOUND COLOR FLOW MAPPING SYSTEM. SYSTEM FIVE
  807. K033926HOURGLASS VERTEBRAL BODY SPACER
  808. K845045VENOUS RETURN CATHETER SS-1
  809. K093531ACUSON MODEL X300 DIAGNOSTIC ULTRASOUND SYSTEM
  810. K902106VPW 2877D5, X-RAY POWER SUPPLY
  811. K222340Chartis Precision Catheter
  812. K253950Avatar Medical Vision
  813. K123348CLEAR ALIGNER ADHESIVE
  814. K830857HARRIS A.R. C. ACETABULAR CUP
  815. K110092TAKE 1 ADVANCED RIGID TRAY
  816. K855189GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET
  817. K952028COLD LIGHT SOURCE LOS XL-A 100
  818. K900683SEVEN ADD'L TRANSDUCERS FOR THE EUB-450 ULTRASOUND
  819. K030645BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
  820. K771592STAT/LYTE ANALYZER
  821. K920737LIFESHIELD VIAL ADAPTER
  822. K941645BIOPSY TRAY
  823. K884288HEARING AID, UNITRON BTE MODEL UM60-AGC0
  824. BK110037Counter, Differential Cell
  825. K031177DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M
  826. K081103LOCI THYROID CALIBRATOR WITH MODEL RC610
  827. K852321SYLVANIA F8T5/PUVA & WALDMANN F15T8/PUVA
  828. K862849HEMOCCULT WIPE TEST
  829. K100337POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
  830. K974346STARLIGHT PULSED DIODE ARRAY LASER SYSTEM
  831. K812761FLOW-DIRECTED BALLOON THERMODILUTION
  832. K230360IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
  833. K772148CATHETER, FEMORAL VEIN, SF 6
  834. K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
  835. K864420CMV MICROASSAY
  836. K880614SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE
  837. K191469Biotronik Stylets
  838. K181999Integra TITAN Reverse Shoulder System
  839. K994027ACTIVATOR PASTE
  840. K860072JUERGENS SELF RELIANT WHEELCHAIR
  841. K790335HYCEL M
  842. K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
  843. K991425XANTOPREN COMFORT
  844. K110639ENDOWRIST ONE VESSEL SEALER
  845. K052773B. BRAUN 0.2 MICRON FILTER
  846. K942615SYRINGE
  847. K093758BGM GALECTIN -3
  848. K892463PATIENT EXAMINATION GLOVES (LATEX)
  849. K861423DEMAND OXYGEN SAVER SYSTEM (D02S)
  850. K042687ENZYGNOST F+2 (MONOCLONAL) TEST KIT
  851. K000454DIMEX 2
  852. K932673APEX SPX CARDIAL
  853. K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
  854. K212988ONO Retrieval Device
  855. K871927CUP BIOPSY FORCEP, 1.7MM
  856. K854932ECUMOL ULTRAVIOLET FACE TANNING UNITS
  857. K870532GALAXY POWERED WHEELCHAIR
  858. K250921CORIOGRAPH Pre-Op Planning and Modeling Services
  859. K080366DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
  860. K163217GORE BIO-A Tissue Reinforcement
  861. K090474ORTHOREX INTRA-OPERATIVE LOAD SENSOR
  862. K061078BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
  863. K895036TITANIUM MODULAR MODULAR COLLARLESS HIP
  864. K945401WHITE STAR
  865. K803286CARDIOMEMO
  866. K965167PERCUTANEOUS VENOUS INTRODUCER 10264
  867. K190290AltiVate Reverse Humeral Stem, 48mm
  868. K871312FIBREFLEX
  869. K202485ImPACT Version 4
  870. K940788AURIUM 830
  871. K890905DISPOSABLE NON STERILE LATEX EXAM GLOVES
  872. K070250NUTRITONE FACIAL BEAUTY SYSTEM
  873. K962627CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
  874. K223714UniFit Dental Implant System
  875. K213483SnapLoc Wire Lock
  876. K970285AESUCLAP SOCON SPINAL SYSTEM
  877. K942965COMPUTER DYNO/GONIO/MYO GRAPHY
  878. K863515MODIFIED SARNS OXYGENATOR SYSTEM
  879. K980816RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES
  880. K834582DETECT GROUP A STREP TEST
  881. K170654USS System
  882. K102337SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE
  883. K842526AMIZYME-LEISHMANIA SPP. TEST KIT
  884. K780092ULTRACHEM ALBUMIN
  885. K822317ARGYLE CAROTID ARTERY LOOP SHUNT
  886. K242960AdVance™ XP Male Sling System (720163-03)
  887. K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and…
  888. K973345MATRIX PLUS MULTI-CALIBRATOR KIT
  889. K081837AVEA VENTILATOR
  890. K852071OHMEDA GMS ABOSORBER
  891. K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
  892. K110019RESPIRATORY HUMIDIFER
  893. K790637COMPUTERIZED ELECTRO-OCULOGRAPH
  894. K892326LATEX EXAMINATION GLOVES
  895. K853291GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300
  896. K123708SPINE COIL
  897. K211570Zeolite Hemostatic Gauze
  898. K240155Cochlear Osia System
  899. K901693TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC
  900. K862526MINI-HOLTER, MODEL 2000
  901. K103800BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES CLINICAL INFRARED…
  902. K181367Tenex Health TX System with the TXP MicroTip
  903. K072951PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES
  904. K162681Enobio Wireless EEG
  905. K000739EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR
  906. K902437COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
  907. K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
  908. K964915MAGNESIUM
  909. K033768ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE
  910. K844264MODEL 493-03 PACING LEAD
  911. K891169DADE THROMBOPLASTIN IS
  912. K790465KNEE COMPRESSION HOOK SYSTEM
  913. K921829RIONET HEARING AID HB-52S
  914. K170298Liberator Beacon Tip Locking Stylet
  915. K210311Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6…
  916. K000564CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
  917. K993390REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
  918. K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
  919. K780411TAYLOR CATHETER HOLDER
  920. K901765POSTEROMEDIAL GUIDE
  921. K791164NEGATOVE PRESSURE CONVERTOR
  922. K160354MX50T(MX50TQS)
  923. K850665CORNEASCOPE MODEL 1200
  924. K060706LIBERTY NORMAL GLUCOSE CONTROL SOLUTION
  925. K820711WALK-A-CYCLE
  926. K231845Dental unit Model: Mare
  927. K091295APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0
  928. K950487GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE
  929. K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic…
  930. K7606664-WAY STOPCOCK W/LUER-LOCK FITTING
  931. K893678DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H
  932. K790429MEDTRONIC MODEL 6957
  933. K010610RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
  934. K912019ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM
  935. K040276QUANTUM CEMENT RESTRICTOR
  936. K140534ELECSYS PRECICONTROL TS
  937. K983913MODIFICATION TO BIO-LOGIC SLEEPSCAN
  938. K901097FILLOCK REAMER
  939. K183396HANAROSTENT FASTTM Biliary (NNN)
  940. K883324DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
  941. K053425PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
  942. K240852da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)
  943. K812526MICRO BLADE II
  944. K223558CUVIS-spine
  945. K163408Isolator Multifunctional Linear Pen
  946. K140504ACCUCATH BC INTRAVASCULAR CATHETER SYSTEM
  947. K210699Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona…
  948. K022859ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
  949. K934815AIR COMPRESSOR, MODEL PAC 6.7
  950. K050831STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
  951. K151440Klassic HD Hip System
  952. K940789AURIUM C
  953. K253204Catalyze
  954. K951476E-PACK PROCEDURE KITS
  955. K954323MAS LIQUID URINALYSIS CONTROL
  956. K201620Luna® G3 BPAP 25A
  957. K240631V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System
  958. K790597SENSOMAT SIDEARM ADAPTER
  959. K970217VISTA ILLUMINATION SYSTEM
  960. K864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT
  961. K213398EMBOLD Fibered Detachable Coil System
  962. K934196CODMAN QUICK SHUNT KIT, CAT. #82-6570
  963. K181525INNOVANCE Free PS Ag
  964. K003728MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM
  965. K911462SURGICAL TROCAR
  966. K823072LECITHIN LACTOSE AGAR
  967. K854674DSL ANDROSTENDIONE RIA (DSL #4200)
  968. K944728BIORESOURCE TECHNOLOGY LIQUICHEMTROL-NORMAL LIQUID HEMAN PROTEIN ELECTROPHORESIS CONTROL
  969. K252006OTTO™ Disinfecting Cap
  970. K892004LIQUICHEK(R) SERUM ALCOHOL CONTROL; LEVELS 1,2 & 3
  971. K090632COMPEX REHAB
  972. K260799Nipro Dry Acid Concentrate Mixer
  973. K242653The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the…
  974. K863225UNITRON MODEL UL21 HEARING AID
  975. K051590T2 ANKLE ARTHRODESIS NAIL
  976. K893740LIPIDIRECT LOW DENSITY LIPOPROTEIN CHOLESTEROL TES
  977. K020750DIGITAL ELECTRICAL MUSCLE STIMULATOR, MODEL EV-807 DIGITAL EMS
  978. K961977KENDALL SHER-I-BRONCH ENDOBROCHIAL TUBE
  979. K922529POWERED MUSCLE STIMULATOR
  980. K874019STAPHSLIDE
  981. K012876DERMAGRIP POWDER FREE LATEX EXAMINATION GLOVES WITH ALOE VERA PROTEIN CONTENT LABELING…
  982. K072937OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET
  983. K182927Pulmonary Cytology Brush
  984. K160239TAP 3, TAP 1
  985. K141624PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH…
  986. K820566PATIENT ISOLATOR #S-10/D-10
  987. K152466Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)
  988. K203804Global Med Systems Milesman Compact Laser
  989. K780453STANICOR THETA MODEL 221 CARDIAC PACER
  990. K260517Automatic Core Biopsy Instrument
  991. BK100056Automated Blood Cell Separators
  992. K082919UC-CARE POSITIONING SYSTEM
  993. K963299HWA-TO ACUPUNCTURE NEEDLES
  994. K792661TREADMILL MODEL 3060
  995. K801360CARDIOTOMY RESERVOIR WITH FILTER
  996. K873295PROSTATIC URETHRO. BALLOON DILATATION CATHETER
  997. K211554InnoGenic Non-resorbable Membrane
  998. K971694ETEST FOR CEFTAZIDIME
  999. K930143AYNELISA M2-ANTIBODIES
  1000. K982447PLUS BIPOLAR PROSTHESIS COCRMO

About this dataset

A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database