Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K031840CAREMATIX WELLNESS SYSTEM
  2. K820446CATHETER, MULTIPLE LUMEN
  3. K851112RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER
  4. K844940SPACELABS MODEL 90201 HOLTER RECORDER
  5. K092895APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
  6. K011560TRUBYTE DENTURE BASE RESIN SYSTEM
  7. K792699OUCHTERLONY AGAR PLATES
  8. K141599DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
  9. K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST…
  10. K831090HEMATOXYLIN GILL FORMULATION IX#56016
  11. K0003553M COMPLY 1249 LIQUID PERACETIC ACID CHEMICAL INDICATOR
  12. K182684HammerTechTM Fixation System
  13. K082415PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
  14. K882036WILLIAMS ACS MARKER NEEDLE
  15. K760711REAGENT SYSTEM (NO. SC 135)
  16. K151760Barricade Embolization Coil System
  17. K241694ZeTTA PACS
  18. K884998SELBY INSTRUMENTATION
  19. K862547MECHANICAL INFLATION DEVICE
  20. K945907KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC…
  21. K203193BD Intraosseous Infusion System
  22. K791916PELICAN BAY KEL-COR CEPHALOMETRIC SYS.
  23. K103714ENCORE ACCLAIM STERILE POWDER-FREE LATEX SURGICAL GLOVES, TESTED FOR USE WITH CHEMOTHERA
  24. K051376ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK…
  25. K072281NEXGEN PROLONG ALL-POLY PATELLA
  26. K841008BIOPSY PUNCH, VARIOUS
  27. K112531VITREA CT MYOCARDIAL ANALYSIS
  28. K140595THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM
  29. K021815SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
  30. K883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602
  31. K173951Legend Acetabular Liners
  32. K924472INSTRUMENTARIUM MEGA4 HT
  33. K250207eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)
  34. K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz…
  35. K090855EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE
  36. K030019MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
  37. K830343CONTAINER W/PRIMING SOLUTION
  38. K033814BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007
  39. K243580GraftGun Universal Graft Delivery System (GDS)
  40. K963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
  41. K935591CEDIA DAU MULTI-LEVEL THC ASSAY
  42. K232968Grande Medical Masks, Model SF-600
  43. K071660VISIONS PV 8.2 INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 88900
  44. K200710Infrared PT2L Digital No-Touch Thermometer
  45. K051007ACCU02 SYSTEM
  46. K080932MOSAIC LASER SYSTEM
  47. K950599STORS SCLERAL SPONGE II (LINCOFF DESIGN)
  48. K971987SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
  49. K172965Handheld VitalSigns Monitoring System
  50. K843206COOK COUNTY HOSPITAL DRESSING CHANGE SET
  51. K771287FINGEO EXTENSION SPLINTS
  52. K881462UNIMODE(TM) POWER MODULE SYSTEM
  53. K911127COLLIMASTER-90
  54. K980402CAPINTEC MODEL 292 ELECTROMETER
  55. K97390117 B-ESTRADIOL (ELISA)
  56. K081564CREASPINE SUPSTANCE VERTEBRAL BODY REPLACEMENT SYSTEM LINE EXTENSION
  57. K231913T-FIT
  58. K071119POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE…
  59. K760882GE CT/T MODEL NO. B7800 A
  60. K951736LOCK-UP
  61. K832505IMAGE PROCESSING SYS A3
  62. K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
  63. K891640PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
  64. K790252ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTI
  65. K883834MEDRAD OMNIPLANE 300 SYSTEM
  66. K896367STERILE SURGICAL DRAPES AND SHEETS
  67. K863235SURGICAL IOP MONITOR
  68. K923844LYRIS 100/120 LABORATORY INFORMATION SYSTEM
  69. K010864ANALYST PANELS + ANALYTICAL TEST ROTOR
  70. K896206STATSPIN STATSAMPLER
  71. K032512Y.E.S POWERED WHEELCHAIR. T180
  72. K192287Transpara
  73. K001331SYNERGY HEAD/NECK COIL
  74. K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…
  75. K990536O.B. TAMPON
  76. K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component
  77. K200957Brainsway Deep TMS System
  78. K771609PEDIATRIC THYROXINE TEST SYS. T4
  79. K962022POWERCUT GOLD SURGICAL SYSTEM
  80. K780986DIGITAL BLOOD PRESSURE MONITOR
  81. K000273SCREENERS OPIATES TEST DRUGSCREEN DIP OPIATES TEST
  82. K926562QUANTA LITE(TM) JO-1 ELISA KIT
  83. K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
  84. K170338A-View
  85. K240807VM-2000
  86. K970759SOLAR SPECS
  87. K201951Cemented Origin Hip Stem
  88. K802187STERILE DISPOSABLE CYTOLOGY BRUSH
  89. K072033OTODYNAMICS OTOPORT
  90. K913766ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
  91. K052900QUILL NONABSORBABLE NYLON BARBED SUTURE
  92. K150007Modified Bencox Hip System
  93. K942941CONQUEST MALE CONTINENCE SYSTEM
  94. K053631CONTOUR TRANSTAR CURVED CUTTER STAPLER SET
  95. K772397COTTLE COLUMELLA FORCEP
  96. K100964POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
  97. K001923REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
  98. K091472URITEST 50 AND URITEST 500 URINE ANALYZER
  99. K770866RABBIT COMPLEMENT
  100. K882089MRM GASTROSTOMY BELT
  101. K964345ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED
  102. K032917NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREE
  103. K770804RESP. SYNCYTIAL-FA LABELLHD (8-301-RF)
  104. K032532TARAS THREADED FIXATION PIN
  105. K163281FastStroke
  106. K841831CANNU-SKREEN-PRELIMINARY
  107. K200722PCA-C1 series Patient Cable
  108. K051546BPCALIBRATOR MC3000/MC3100
  109. K925311TRILOGY INFUSION PUMP
  110. K122389TRUSCULPT
  111. K071033T2 XVBR SPINAL SYSTEM
  112. K771101HEMOGLOBIN ANALYZER & PERFORM. CHECK SET
  113. K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
  114. K951037AKISU FOLDING WHEELCHAIR, MODELS AW-900, 910, 920, 930, 950 AND AW-820, 830
  115. K141356ECHO TIP ULTRA FIDUCIAL NEEDLE
  116. K923963NK DIGI-GRIP SENSOR, MODEL DGR001
  117. K002287WIZAIR COMPRESSION SYSTEM
  118. K841856AMER. MED. OPTICS ARGON/KRYPTON LASER
  119. K992729NIPRO LUER ADAPTOR
  120. K863859TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM
  121. K020040LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
  122. K202026Blue Sky Bio CAD-CAM Abutments
  123. K990631CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS…
  124. K842824CHERMEL BONE CHISELS
  125. K913108TEFLON COATED ELECTRODES/ELECTRODES HANDLES
  126. BK060056Blood Establishment Computer Software and Accessories
  127. K896225COBAS READY PROFILE 2 REAGENT STRIP
  128. K070589C!
  129. K965062SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
  130. K181790CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
  131. K895745SICKLE CELL SOLUBILITY TEST KIT
  132. K833723MODEL 2000 AMBULATORY MED. INFUSER
  133. K873343ENTUBE-MEER AND MEER FEEDING TUBE BRIDLE SYSTEM
  134. K172785CONQUEST FN
  135. K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX
  136. K946156DEPUY COMPRESSION HIP SCREW SYSTEM
  137. K090242GAMMA-BSM, BETA-BSM
  138. K860024FUKUDA DENSHI CARDIMAX FCP-211
  139. K143633CREO Stabilization System
  140. K241438Signus Tetris™ St; Signus Tetris™ R St
  141. K212523VFSS Pro Mobile Digital Imaging System
  142. K902155HI CHEM ISE REAGENTS (PRODUCTS #88960 AND #88964)
  143. K103272ZENIUS SPINAL SYSTEM
  144. K210958i-STAT CHEM8+ cartridge with the i-STAT 1 System
  145. K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE
  146. K062736SIASCOPE V
  147. K821720PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000
  148. K203653MRI PPG Patient Cable
  149. K122813HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
  150. K171465Stryker Self-Punching ICONIX
  151. K170386BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes…
  152. K812474BABY WALKER W/TOY CHEST
  153. K853349VARIAN XIMATRON C-SERIES RADIOTHERAPY TREATMENT ST
  154. K851988ADMINISTRATION SET
  155. K033350BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER
  156. K160984MultiScan G-Arm System
  157. K000716ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
  158. K252607AllTest Urinary Tract Infection Test
  159. K971250LASERSCOPE MICROBEAM IV MICROMANIPULATOR
  160. K873488SILENT GUARD CAT. NO. SG-10
  161. K832425GREAT LAKES PASTE SOLDER
  162. K231054V-Laser
  163. K000276MPT 24 AND VITAL VIEW 24
  164. K926107ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS
  165. K843399SURGEONS CHOICE PI VASCULAR STAPLING
  166. K071307INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501, 140001, 140002, 140003
  167. K830731NETILMICIN 30 MCG ANTIMICROBIAL DISK
  168. K933572URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125)
  169. K162862Raycast High Precision Lung Board Solution
  170. K251822MAGNETOM Free.Max; MAGNETOM Free.Star
  171. K791289GIZMO TOWEL CLAMP
  172. K810164VC 430 VIDEO CONVERTER
  173. K213261EpilME
  174. K113551ESOPHAGEAL TTS STENT
  175. K872644INNOFLUOR VANCOMYCIN CALIBRATOR SET
  176. K113198NMI CONTROL SYRINGE, 7 ML NMI CONTROL SYRINGE, 8 ML
  177. K040669CERAFORM BONE VOID FILLER
  178. K122874POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
  179. K030936RITA CLIPS FOR INFUSION PUMPS
  180. K080860CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM
  181. K032503EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
  182. K060280ICHEM 100 URINE CHEMISTRY ANALYZER
  183. K862100MODEL ED BEHIND-THE-EAR HEARING AID
  184. K251565Wheelchair (N817)
  185. K874548SIM 4000C
  186. K781748IRRIGATION TRAY
  187. K953295ANESTHESIA FACE MASK
  188. K010090XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED)
  189. K202406Butterfly iQ Ultrasound System
  190. K870705THERMAL COAGULATOR
  191. K800672SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
  192. K840281ANGIOGRAPHIC DRAPE PACKS
  193. K053034ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000
  194. K020712ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-4
  195. K850317UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050
  196. K120561NEUROBLATE SYSTEM
  197. K820231COMMAND ULTRA I
  198. K941105UORCAP,MODEL NUMBER UDS-UCAP
  199. K903686ARGILITE 4 GOLD ALLOY FOR PORCELAIN
  200. K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)
  201. K970877IMMULITE CEA
  202. K001760RADIOLUCENT COLLES FRACTURE KIT
  203. K920060DENTAL SOLDER ALLOY
  204. K780059RABBIT ANTIBODY/THYROID STIMUL. HORMONE
  205. K033590ERBE HELIX HYDRO-JET
  206. K220232Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
  207. K061412THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401
  208. K900076SHARPLAN FLEXIBLE CO2 SURGICAL LASER APPLICATOR
  209. K800265BORDETELLA SELECTIVE SUPPLEMENT
  210. K132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
  211. K153505F&P Eson 2 Nasal Mask
  212. K880785SKILCRAFT
  213. K842438DISPOSABLE SURGERY HOOD
  214. K100384FIBERLASE C02 LASER WAVEGUIDE
  215. K122022ATHEROEDGE
  216. K873728DEKNATEL TEMPORARY CARDIAC PACING WIRE
  217. K001420SLIDESCAN
  218. BK000036Counter, Differential Cell
  219. K200461Freeprint denture
  220. K841073QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE
  221. K0310983-CCD DIGITAL CAMERA SYSTEM
  222. K240946Gastric Alimetry
  223. K140955MTA2.1 MATERIAL
  224. K232295LAA Exclusion System
  225. K843913COBAS FP TDM CONTROLS
  226. K821056FLOW DIRECTED THERMAL-DILUTION CATHETER
  227. K920078AFFINITY B12
  228. K092423XPECT FLU A & B
  229. K230691HyperVue™ Imaging System
  230. K240264Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A…
  231. K913987OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID
  232. K880498RM-301 PATIENT MONITOR
  233. K896463RESOUND CUSTOM IN-THE CANAL HEARING AID MODEL CA1
  234. K954651ELECTRODE RECORDING CATHETER
  235. K880674MICROMEDIC CRACKPOT RIA KIT
  236. K902515ACUSON S228 TRANSDUCER FOR TRANSCRANIAL COLOR DOPP
  237. K922451LEGACY-XT
  238. K925744TEMPA-KUFF SINGLE PAT PRE-GAGED BALANCED DISP CUFF
  239. K913563MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY
  240. K913047STERILESERT(TM) CABLE AND POLE DRAPE
  241. K903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTS
  242. K884557ADVANCED SURGICAL PRODUCTS SCISSORS HANDPIECE
  243. K221983Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free…
  244. K011922POWDERED LATEX EXAMINATION GLOVES
  245. K871222TANTONE MULTI-DAY #633 TENS ELECTRODE
  246. K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)
  247. K102305HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P
  248. K031110APEX MODULAR ACETABULAR CUP
  249. K062699PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
  250. K110770HEALTHTRACKER
  251. K833331ASPIRATION & IRRIGATION CATHETER
  252. K761127LONG HANDLED BATH BRUSH
  253. K013688MODIFICATION TO XIA SPINAL SYSTEM
  254. K842316CRITIKON TRIPLE-LUMEN CENTRAL VENOUS
  255. K810855INTERFACE 20 MICRON TRANSFUSION BLD. F.
  256. K972038INTRUDER
  257. K945364DYRACT(TM) MATERIAL
  258. K981310MAGNATEK C-300
  259. K790903TRACOR MODEL RA-411 MICROPROCESSOR
  260. K09404718 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14…
  261. K032812ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
  262. K892523GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
  263. K925577DANEK TISSUE RESECTING SYSTEM
  264. K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
  265. K921854IMPLA-MED HEX SCREW IMPLANTS, 18 AND 20 MM
  266. K811597UREA AGAR SLANT
  267. K071196DISPOSABLE HIGH PRESSURE INJECTION LINES WITH AND WITHOUT ROTATING ADAPTERS
  268. K002589OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
  269. K881598SDL TRICHROME STAIN
  270. K895792DEXTROLYTE II CAPD TRANSFER SET - NO. 48-4009-6
  271. K152677geko T-2 Neuromuscular Stimulator
  272. K902592EPC ELECTRONIC PIPETTING SYSTEM
  273. K001041AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED, AGC-GOLDBONDER…
  274. K964442VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM
  275. K093913MERCURY MEDICAL T-PIECE RESUSCITATOR
  276. K233141SmartFrame OR
  277. K080614DR VISION NEO, DR VISION DOU
  278. K132718INTEGRITY SPINE CORE SYSTEM
  279. K231252Ventana™ L Spinal System
  280. K843603AUTO SUTURE POLY GIA SURGICAL STAPLER
  281. K180801Actreen Hi-Lite Cath, Actreen Hi-Lite Set
  282. K102668ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
  283. K852374OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18
  284. K170952syngo.CT View&GO
  285. K873972GUIDE WIRE INTRODUCER
  286. K884895ACS 0.010 HI-TORQUE FLOPPY GOLD GUIDE WIRE
  287. K143615Antistatic Compact Space Chamber
  288. K912059PRE-ANGLED ABUTMENTS
  289. K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
  290. K926369WALTHER CATHETERS, MALE, FEMALE
  291. K964047CRYOSIL SILICONE GEL SHEETING
  292. K000220MA-300 ELECTROMYOGRAPHY SYSTEM
  293. K073670KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260
  294. K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
  295. K261102UNIDRIVE Select System
  296. K120731TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
  297. K951688MICRO TITANIUM PLATE SYSTEM
  298. K931301OLYMPUS AMYLASE REAGENT
  299. BK850001System, Test, Automated Blood Grouping and Antibody
  300. K032360MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS…
  301. K140199VUPAD
  302. K211543Wei Nasal Jet Tube
  303. K212448NightGuard Flex
  304. K781974IMPLANT DRIVERS AND TIPS
  305. K945198DIDECO PEDIATRIC ARTERIAL FILTERS
  306. K964158JEL-40 (CODE NAME RD-0430)
  307. K850625ARGYLE 15MM SWIVEL CONNECTOR
  308. K843139ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND
  309. K905447E-Z-EM PULSED INFUSION SYSTEM
  310. K962830VISTA BRITE TIP CATHETERS
  311. K971679I-SCOPE OPHTHALMIC ENDOSCOPE
  312. K061116MOBILLIFE - MODEL (MOBIL RAIZER 22) - POWER WHEELCHAIR
  313. K820810#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
  314. K951878SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
  315. K982626URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT…
  316. K914853ANTINUCLEAR ANTIBODY (ANA) SCREENING TEST KIT
  317. K950491RICH-MAR CARBON ELECTRODES
  318. K182947Dental Pain Eraser
  319. K222398Care Team Portal
  320. K220424Through the Scope Tracheal Stent System
  321. K060079KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM
  322. K893450LATEX EXAMINATION GLOVES
  323. K133098SENYINT PACS
  324. K991169SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854
  325. K213000Air Compression Massager (Model LF-FT003)
  326. K052518PIEZOSURGERY
  327. K864401PLURIMUS CARDIAC EVALUATION SYSTEM
  328. K890446ANESTHETIC GAS MONITOR
  329. K962706EZ-FIX CANNULATED SCREW SYSTEM
  330. K141359HARD PACK SYRINGE
  331. K072237MAGNETOM VERIO
  332. K203469AI Segmentation
  333. K880165TRUST RPR TEST FOR SYPHILIS IN SERUM OR PLASMA
  334. K161602Arctic Sun Temperature Management System
  335. K921214OPHTHALMIC PROJECTOR
  336. K852387GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE
  337. K813016ZEE TRACTION SPLINT
  338. K182494FlowMet-R
  339. K925717CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE
  340. K082837STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
  341. K133223XENMATRIX AB SURGICAL GRAFT
  342. K930768ORION DIAGNOSTIC ULTRASOUND SYSTEM
  343. K830588POTASSIUM ANALYZER-SODIUM/ELECTROLYTE
  344. K810221SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
  345. K170773Stryker Universal Mesh
  346. K030963TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS…
  347. K843533CARDIAC EVENT RECORDER
  348. K952065PACEART CARDIOVOICE
  349. K162912VIPER PRIME™ additions to the VIPER® System
  350. K923720SUNCAST
  351. K831337COMPRESSAR DISPOSABLE DISC
  352. K173491RTS Lesser MTP Implant System
  353. K940785MOUTH PROPS
  354. K130430IVAS 10MM AND 15MM BALLOON CATHETER
  355. K962564RICHARDS TOTAL/PARTIAL PROSTHESIS
  356. K121560LEVANT, HOMEGLIDE
  357. K830017VOLUMETRIC PUMP ADMIN. SETS
  358. K871188LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
  359. K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual…
  360. K855138BOVIE ULTRASONIC SURGICAL SYSTEM
  361. K200989Reliance Endoscope Processing System
  362. K082306POWERLOC CLEAR SAFETY INFUSION SET
  363. K153717Venus Versa System
  364. K913429EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS
  365. K830349SAC-RO-FORM INSERT & BINDER
  366. K063044CARDIOBELT ELECTRODE BELT
  367. K040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
  368. K051943SUREFLOW SAFETY INFUSION DEVICE
  369. K811519K-FLEX
  370. K910069SR-ISOSIT SPECTRA LINK SYSTEM
  371. K233207Polaris X™ Unidirectional Steerable Diagnostic Catheter
  372. K003115ACTIS ADJUSTABLE CONSTRICTION LOOP
  373. K173554PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and…
  374. K252847NextAR Hip Platform
  375. K853845ALLOY B
  376. K011842SABRE COMPAC
  377. K920940AMERLITE FREE THYROID CONTROL SERA LAN.4002
  378. K842658ANTI-CHLAMYDIA TRACHOMATIS KIT
  379. K863660EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
  380. K781205TOILET AID
  381. K931743BURRON CARDIOVASCULAR ANGESTAT(TM)
  382. K132441BARD VENTRALEX HERNIA PATCH
  383. K232146Anovo Pedestal
  384. K032457MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
  385. K890281HUMAN LYME EIA FOR THE DETECT OF ANTIBODIES
  386. K032878KUNG SHIN, HMEF SK203
  387. K901815MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY
  388. K042755MONOCHROME LCD MONITOR, RADIFORCE G51
  389. K896265QUIDEL GROUP B STREP TEST
  390. K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)
  391. K813206HEARING AID CUSTOM ITE
  392. K844050ARTHOPOR-ACETABULAR COMPONENT
  393. K042987MODIFICATION TO SYNTHES CRANIAL PLATES
  394. K201200Visera Elite II Video System Center
  395. K060123LEVELERT II FLUID LEVEL SENSOR
  396. K982018LIGHT SABER ASPIRATION NEEDLE
  397. K131027MEMORY PUMP MODEL Y4947
  398. K203141Uramix CuraWay Biopsy Needle
  399. K234097Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with…
  400. K863116CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
  401. K123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPERED
  402. K072120PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE
  403. K113478PLIF CAGE
  404. K924262ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
  405. K932241ECONOMY HI-LOW MAT TABLES/ELECTRIC MODELS
  406. K812527IVA SEAL II
  407. K040397MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
  408. K002137CATHCOR DESKTOP
  409. K790957HISTO-DISPENSER
  410. K993373ROTORBLADE SUTURE ANCHOR
  411. K832511RECLINING WHEELS
  412. K003951PECTOFIX STERNAL REPAIR WIRE
  413. K163666neuro inspire
  414. K021264TRZ-CG POWER POSITIONING SYSTEM WITH CENTER-OF-GRAVITY SHIFTING POWER TILT, RECLINE, AND…
  415. K972245TOM CAT F.L., TOM CAT S.L.
  416. K911662MARQUETTE PEDIATRIC DEFIBRILLATION/PACING PADS
  417. K950075MED-TEC TRAY ADAPTER
  418. K981769HICHEM PHOSPHORUS REAGENT KIT
  419. K791043LINDE OXYGEN CONCENTRATOR MODEL LOC-HC
  420. K183316Dr J Spinal and Epidural Needles
  421. K953446AESCULAP BIPOLAR CORDS
  422. K781316PULSED AND CONTINUOUS SHORTWAVE APPAR.
  423. K950541HOWMEDICA V40 22MM FEMORAL HEAD
  424. K974095FOUNDATION POROUS COATED FLARED RIM SHELL
  425. K934553WHEEL-O-VATOR
  426. K884984M40 K KARAYA GUM DISP. MICROTAPE ECG ELECTRODE, 40
  427. K212978Diode laser therapy system
  428. K212697Leaf Smooth
  429. K861893GGT REAGENT CARTRIDGE (PRODUCT NO. 88204)
  430. K091189ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
  431. K883274SURGITEK (R) UROFLOW SYSTEM
  432. K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
  433. K896950CORE BUILD UP COMPOSITE
  434. K984081EMOX
  435. K900392CENTERING PLUG
  436. K170010Salle Intraoperative Pyeloplasty Stent Set
  437. K780595MINI-IRRIGATION TRAY
  438. K974670ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1…
  439. K020502SOLO ORTHO 3
  440. K121073POWERGLIDE MIDLINE CATHETER
  441. K031104POWDERED VINYL EXAM GLOVES, WHITE
  442. K800676REAGENTS FOR DETERM. SODIUM IN HUMAN SUM
  443. K832582MYCOSEL AGAR
  444. K862412INTESTOPLANT
  445. K251231ViewFlex™ X ICE Catheter, Sensor Enabled™
  446. K040399QONTRAST
  447. K946274COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN
  448. K842187MULTIPLE LENS, SPECTACLES, CUSTOM
  449. K243721Self Sealing Sterilization Pouches
  450. K033805SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES
  451. K213509Latex Examination Gloves, Powder Free
  452. K062731ULTRASONIC SCALER, VARIOS 560
  453. K942778MODEL VPW2877F8, MAMMO 5 POWER SUPPLY
  454. K831550FINGER BONIOMETER BK7506
  455. K862002MEDISYSTEMS PHERESIS NEEDLE
  456. K912690AUGUSTINE GUIDE(TM) KIT
  457. K894078LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
  458. K860349LACTATE DEHYDROGENASE (LDH) REAGENT SET
  459. K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid
  460. K892774PATIENT EXAMINATION GLOVES
  461. K162539Solitaire 2 Revascularization Device
  462. K1430112014 InterActive/SwishActive System
  463. K862058RAPID ENDOSCOPIC LAVAGE SYSTEM
  464. K992885VERSALOK LOW BACK FIXATION SYSTEM
  465. K781706RESPIRATOR/GILL 1/SIMV
  466. K874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
  467. K970019MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
  468. K990845MODIFICATION TO PARTS NUMBERED CGT-SL AND CGT-SL-15
  469. K822814EMG 100T
  470. K884434VORTECH'S MEDICAL IMAGING GATEWAY
  471. K071936WOUNDSTAT, MODEL TC1001
  472. K091562DOCTOR SMILE A-810 AND B-980 LASERS
  473. K181735Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
  474. K854061SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM
  475. K070683MIRAGE CEDARS OPTION
  476. K252496Neurophet AQUA AD Plus
  477. K861082CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
  478. K212907Aimanfun Lumea Comfort, A-2789/A-3588
  479. K072175TITANIUM HIP TOOL LOCKING PLATE
  480. K843579ULTRACLONE ECL-01-1100
  481. K895881MOTIONSPECT
  482. K792169HORIZONTAL RADIOGRAPHIC 4/WAY FLOATING
  483. K120501CHAMP CHAMP TRANSIT
  484. K131181OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE
  485. K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
  486. K003396BURN JEL PLUS
  487. K863175EES 10 ELECTRODELESS ELECTRICAL STIMULATOR
  488. K091672DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES
  489. K073227SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
  490. K840836CAT 100
  491. K203231Switched Internal Paddles
  492. K180083Silicone Personal Lubricant, ALL-IN-ONE
  493. K030444PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
  494. K873346MODEL 2240 SLAVE SCOPE
  495. K972842INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE
  496. K250454HardyDisk Aztreonam/Avibactam 30/20µg (AZA50)
  497. K933950LADY'S CARE MAXI PADS
  498. K881826ENDO-ICE
  499. K925650IMAGEVIEW 5000
  500. K903060ARGENCO 34
  501. K001528PC FLOW +
  502. K85175313-100 TO 13-158 VARIOUS TYPES OF OPERATING SCISSO
  503. K941840HEMAGEN ACL IGA CALIBRATOR
  504. K981798LACTOSORB POP RIVET
  505. K991792CRYO-MONO CRYOGENIC SYSTEM, MODEL CRYO-MONO WITH TUF PROBE
  506. K220724CD Horizon™ Spinal System and PASS LP™ Spinal System
  507. K160554Enseal X1 Large Jaw Tissue Sealer
  508. K910955HSV-1 IGM ELISA TEST
  509. K002323ADVANCED UROSCIENCE INJECTION NEEDLE
  510. K895741CLAS PHOTOKERATOSCOPE
  511. K800806I.C.S. MINI & SMALL FRAGMENT SET
  512. K090560CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS
  513. K181374NRFit Syringe
  514. K971473IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
  515. K851996LD-L REAGENT
  516. K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
  517. K891263SHIELDTEX PATIENT EXAMINATION GLOVE (LATEX)
  518. K120760LDR SPINE SPINETUNE TL SPINAL SYSTEM
  519. K180514VERITON NM
  520. K251671Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems
  521. K981578CA
  522. K072767QUASAR BLUE LIGHT THERAPY SYSTEM
  523. K801691TSH RIASSAY
  524. K901191TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING)
  525. K123821AIO HD OTOSCOPE
  526. K991105ECG ELECTRODE (VARIOUS)
  527. K914495E.R.C.P. CATHETER
  528. K993051VERSALET 7700 CARE CENTER, MODEL # 7700
  529. K911427BREATHING FILTERS
  530. K800634OHIO DISPOSABLE TRACHEAL TUBE
  531. BK020002Blood Establishment Computer Software and Accessories
  532. K170638Retina Workplace
  533. K883836COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
  534. K880573MODIFIED NICOLET VIKING SYSTEM
  535. K941600MT-300 CASSETTE HOLDER
  536. K902761AUTOMATIC CASSETTE LOADER
  537. K921132SYN ELISA DSDNA ANTIBODIES
  538. K222181Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate
  539. K892742PATIENT EXAMINATION GLOVES (LATEX)
  540. K914172KPE 230 AM
  541. K941023RAREX GREEN FAST
  542. K930534TMC I, II
  543. K780743CLAMP FORCEPS
  544. K854041CD-100 CARDIAC MONITOR
  545. K874688FLOWTRON AC200/2
  546. K243872BD Veritor System for SARS-CoV-2
  547. K021388CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM…
  548. K202019Maven Patient-Specific Instrumentation
  549. K9609143I OSSEOUS FIXATION SYSTEM(S)
  550. K024335CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
  551. K211791Ez3D-i/E3
  552. K171379Digital Automatic Wrist Blood Pressure Monitor MD4300
  553. K043034OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
  554. K153408HM70A Diagnostic Ultrasound System
  555. K211120ERIC Retrieval Device
  556. K1532776200 Ultrasound System and 6250 Ultrasound System
  557. K891220SINTON LATEX EXAMINATION GLOVE
  558. K940181SE-CHECK
  559. K120815INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
  560. K874461HEMO-SOL
  561. K962354DIOMED 15, 30, 60 SURGICAL DIODE LASER
  562. K190151COBRA Fusion Ablation System
  563. K191274BonAlive Granules
  564. K834008SABOURAUD DEXTROSE AGAR
  565. K971845HEARTLAND TECHNOLOGIES, ITE, ITC, CIC
  566. K860698THE BOOSTER
  567. K873951MICRO CULTURE MEDIA P3528, P3137, P3149, P3139
  568. K002482VISION 9000 PHASED ARRAY TORSO COIL
  569. K904325COAG-1 PT-NC TEST CARD
  570. K973872ATRION MEDICAL COATED LACRIMAL INTUBATION SET
  571. K071717GE OEC ALTITUDE
  572. K871873CLOSED CHEST DRAINAGE SET
  573. K901170PERIODONTAL KNIFE
  574. K926214GUIDE WIRE FOR LAPOROSCOPIC USE
  575. K9461623M(TM) SURGICAL SLIPPER, 9660 SERIES
  576. K772378NEIVS TRACHEOTOMY RETRACTOR
  577. K230492Avitus® Precision Autograft Delivery System
  578. K141935STRYKER S2 DRILL
  579. K983100KAVO KEY LASER 1242
  580. K895120BATEMAN UPF II HIP PROSTHESIS SYSTEM
  581. K170842WEGO-PTFE
  582. K241589Ceribell Seizure Detection Software
  583. K900380MEDILASE 5010 ENDOSCOPE CONSOLE
  584. K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
  585. K761167ENEMA KIT
  586. K760733SKIN STAPLE EXTRACTOR
  587. K990920DRG TITANIUM BONE PLATE
  588. K080034THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
  589. K172253Altus Spine Cervical Interbody Fusion System
  590. K950801CARDIO REP LD CONTROL - CAT NO. 3325
  591. K173785Custom Clear Aligner System
  592. K981003ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES
  593. K213517Access Thyroglobulin Antibody II
  594. K894103SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II
  595. K9318152000 X-RAY - TOMOGRAPHIC
  596. K191582Cartesion Prime
  597. K890515PERIPHERAL ATHERECTOMY SYSTEM
  598. K932221NEUROLOGICAL OR CRANI TRAYS (PACKS)
  599. K041346SYNERGY ULTIMATE
  600. K910579OVARIAN ASPIRATION/IRRIGATION NEEDLE
  601. K210534GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
  602. K904139SINGLE LUMEN CATHETER KITS
  603. K132830DISTALOCK TIBIAL IM NAIL SYSTEM
  604. K883747IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES
  605. K911913PRECISION GLIDE - ENHANCED SURGICAL BLADE
  606. K924679OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
  607. K992904MINI-PORT
  608. K840304CATEGORY 17-MICROBIOLOGY DEVICES
  609. K132457FORA DIAMOND NEXUS MINI INFRARED FOREHEAD THERMOMETER
  610. K000031AQUANET, MODEL EC 2000
  611. K934049BII-PORE(TM) CANAL WALL PROSTHESIS
  612. K950255ARGUS HYSTEROSCOPY INSTRUMENT SYSTEM
  613. K811570ANTIBODY TO CHLAMYDIA TRACHOMATIS
  614. K191749TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
  615. K941680SUNGLASSES
  616. K973888SMARTLOCK SAFETY SYRINGE
  617. K073640ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS
  618. K823005BIO MAG FREE T4 RADIOIMMUNOASSAY KIT
  619. K860346KERR PORCELITE
  620. K220627SURGIVISIO Device
  621. K791517COLUMBIA BLOOD AGAR
  622. K860770AM-100 I/A AMPAC
  623. K023954ALTUS MEDICAL COOLGLIDE LASER SYSTEMS AND ACCESSORIES
  624. K831543ADJUST. WEIGHTS-BK5171-05,10,20 BEOK
  625. K150132IMMULITE IGF Control Module, IMMULITE Gastrin Control Module
  626. K032753GLUCOSE TOLERANCE BEVERAGE
  627. K792389WIDEX HEARING AID MODEL S10
  628. K150814Straumann Screw-Retained Abutment
  629. K022898PTS PANELS LIPID PANEL TEST STRIPS
  630. K170238BodyTom Elite
  631. K011473SNAZZY2
  632. K882074SUCTION RETRACTORS
  633. K920251USCI HEMAQUET XT INTRODUCER
  634. K200614FiteBac Antimicrobial Cavity Cleanser
  635. K910365WOUND CLOSURE KIT
  636. K885252MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001
  637. K230679WellsForm Tricuspid Annuloplasty Band (WF)
  638. K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT
  639. K961968BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
  640. K130028RESURFX 1565NM LASER MODULE
  641. K024327SETPOINT ENDOVASCULAR TEMPERATURE PROBE
  642. K181280Patello-Femoral Wave (Kahuna) Arthroplasty System
  643. K082103LTM WOUND DRESSING
  644. K9918611ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL…
  645. K910953HSV-2 IGM ELISA TEST
  646. K162078EVOS Small Fragment Plating System
  647. K982459TEMPFIL F - 2
  648. K213975KEOPS Balance Analyzer 3D
  649. K802264WASH SOLUTION KIT, #88102
  650. K962857COAG-A-MATE MTX
  651. K111882LAMINAR FLOW PHACO TIPS
  652. K820205VP 2
  653. K955400QUEGEL HYDROPHILIC WOUND DRESSING
  654. K913916HYDROXYLAPATITE COATED TI-FIT FEMORAL COMPONENT
  655. K071314SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS
  656. K161077RnD TE and RnD SE
  657. K904109BIO-IMPEDANCE ANALYZER
  658. K871792VEOLAR VENTILATOR
  659. K213900WAVi SCAN EEG System and Accessories
  660. K790244CYSTOTOMES
  661. K083206LOUSEBUSTER
  662. K953719HUMAN TUBAL FLUID
  663. K213758Lexa PLUS RIS-311
  664. K874623FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101
  665. K895413ACROMED DOUBLE SUBLAMINAR WIRE
  666. K032396RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
  667. K092689MANUKAPLI WOUND DRESSING
  668. K053259DISPOSABLE PVC EXAMINATION GLOVE, POWDERED AND POWDER-FREE
  669. K981923THE SNORE PEACE
  670. K800283OTICON MODEL E17VF EARETTE HEARING AID
  671. K042073OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
  672. K020806ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY
  673. K041600QWIKCHECK-BEADS
  674. K061645MAGPRO, MODEL R30
  675. K974112VACUDAP, MODEL 2000, 2001
  676. K842168ATAGO URINE SPECIFIC GRAVITY & SERUM
  677. K811852REDUCT-ASE TUBES
  678. K925114LAPAROSCOPIC INSTRUMENTS
  679. K933203APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
  680. K002570BIO-LOGIC CEEGRAPH NETLINK
  681. K051104EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
  682. K230945Forma Medical Headless Compression Screw
  683. K854424BARD PARKER 150CC BELLOWS RESERVOIR
  684. K073159TRAUSON BONE SCREW, MODELS HA 3.5 AND 4.5
  685. K022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
  686. K954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SET
  687. K231317TrueBeam, TrueBeam STx, Edge, VitalBeam
  688. K230594Tigereye ST CTO-Crossing Catheter
  689. K240127PlumeSafe X5 Smoke Management System
  690. K262116TRUE METRIX Self Monitoring Blood Glucose System
  691. K222833Ventana™ C Spinal System
  692. K840298MCA IN THE EAR CUSTOM HEARING AID
  693. K211937SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
  694. K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
  695. K102249EXPEDIUM SPINE SYSTEM
  696. K931037WHITMORE VACUUM-LOCK SPINAL FRAME (VLSF-100)
  697. K230528Extension Set
  698. K173838ARIA Radiation Therapy Management
  699. K790280AUTOANTIBODY REAGENTS, AFT SYSTEM II
  700. K922569TETRIC LIGHT-CURING COMPOSITE
  701. K991436STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND…
  702. K141565GLOBE-TROTTER GT5400
  703. K081132SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
  704. K1003781 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
  705. K813151VITATRON INSERT
  706. K0809773 CCD ENDOCAM 5550
  707. K173896Microcyn Antimicrobial Hydrogel
  708. K971214KILOWIN
  709. K955844APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
  710. K811060POLYETHYLENE MEDULLARY PLUG
  711. K953673ECLIPSE PROBE COVER
  712. K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly…
  713. K002664HARDYDISK LEVOFLOXACIN, 5MCG
  714. K151100U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose…
  715. K003758ALLOFIT ACETABULAR SYSTEM
  716. K9435097300 NASAL CPAP SYSTEM
  717. K790509CARDIOCASSETTE II, AMBULATORY ECG SYSTEM
  718. K844373O.M.S. ULTRA-PHACO
  719. K850925BLOOD TUBING(PVC) 201458 W/(TOTM) PLASTICIZER
  720. K192388SonoVision Ultrasound Imaging System
  721. K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
  722. K133017ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
  723. K913336ABUSCREEN(R) ONLINE(TM) CONTROLS
  724. K832697RMP INTUBATION EQUIP. STORAGE TRAY
  725. K771882REPLICA DENTAL COMPOSITE-RADIOPAQUE
  726. K935987FLEXTRANS
  727. K914576KELLER CARDIAC MONITOR MEDIL KMS870
  728. K882499JAYCO HYDROGEN MONITOR
  729. K961124THE NAUTILUS
  730. K961501ELECSYS CK-MB
  731. K041534SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC SUSCEPTIBILITY PLATE AND…
  732. K152558Leksell Stereotactic System, Injection/ Aspiration Needle Kit
  733. K130940KYMCO EQ20C SCOOTER
  734. K101068ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
  735. K061918FOLEY CATHETERS WITH TEMPERATURE PROBE
  736. K240824Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003…
  737. K833746TECH. RA-1000 SYS SERUM CHLORIDE
  738. K024064POLARIS DS
  739. K921321ORTHO CHLAMYDIA ANTIGEN ELISA TEST
  740. K952973THE TULIP MONO-POLAR CAUTERY SPATULA
  741. K842136STERILE PAN SET
  742. K191321Primelase Excellence
  743. K891702PATIENT EXAMINATION GLOVES (LATEX)
  744. K250867Dunamis Screw and Suture Locking System
  745. K912023LASERSCOPE DISPOSABLE LAPAROSTAT W/IRRIG & ASPIR
  746. K922348VALTRAC(R) INTRODUCER FORCEP
  747. K863133PROPHY CARE PASTE
  748. K910027CRYSTAL FOCUS EMERALD LASER SLT MCX 1.5 CONVEX PRO
  749. K132362WECK EFX ENDO FASCIAL CLOSURE SYSTEM
  750. K000287BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO
  751. K850218SWIM'S S-77 POWDER MEDIUM
  752. K920150ENCORE SCL-70
  753. K874662MYCO-FLUOR REAGENT A & B
  754. K844279INTERCEPTOR, 662-01
  755. K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)
  756. K864510PSORALITE 12800 SERIES
  757. K863402MEDI-PLAST DISPOSABLE MANIFOLD
  758. K915179PHENCYCLIDINE EIA ASSAY
  759. K904252HEATWAVE
  760. K024004XIVE TRANSGINGIVAL DENTAL IMPLANT SYSTEM
  761. K922299ZEPPELIN MOTOR DRILL SYSTEM
  762. K020295NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART #…
  763. K944349OXYLATOR EM-100
  764. K951014ISOLAB'S T4 TEST KIT
  765. K041281DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
  766. K842093MK 700 ULTRASOUND SYSTEM
  767. K092183EMBRYOSCOPE AND EMBRYOSLIDE
  768. K050611ENDOTINE RIBBON
  769. K061455DORNIER MEDILAS H 20 LASER
  770. K811352POLAROID TPX RADIOGRAPHIC FILM
  771. K062774BELMONT BUDDY PLUS FLUID WARMER
  772. K872073BIO-INTERFERENCE BLANKING MATERIAL, AM CAT. #2052
  773. K801837PLASTIC STRIP BANDAGES
  774. K935144DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
  775. K951863ROLLER ELECTRODE
  776. K100138ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
  777. K840021OPERATING ROOM TRAY SET
  778. K013762RIGID GAS PERMEABLE CONTACT LENS
  779. K191937Ezvena IPC, Ezvena SQS
  780. K982148PRODIGY 2
  781. K831648ANCHOR BRAND SURGICAL NEEDLES
  782. K972938AURECAST 10
  783. K102366FINESS ENDOSCOPE
  784. K945428SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION
  785. K944782CATCO UROLOGICAL CATHETER
  786. K851092PORTABLE DEFIBRILLATOR/MONITOR ED 425
  787. K100479PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
  788. K890438GAS-VAK(R), MODEL 300
  789. K980147YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
  790. K142649Progressive Orthopedic Total Knee System
  791. K950533TROPHY RADIOLOGIE RVG RADIOVISIOGRAPHY
  792. K963247VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
  793. K200747PuriLens Plus Preservative Free Saline
  794. K882926MODEL AU-1 ACCESSORY UNIT
  795. K241530Stellar Imaging System
  796. K030813PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE…
  797. K971916MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL
  798. K911107SONARSCAN 128 ULTRASOUND SCANNER
  799. K944344LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER
  800. K941593DIAGNOSTIC ULTRASONIC TRANSDUCER
  801. K852906DURACLEAN DENTURE CLEANER
  802. K043597FC 700 FETAL MONITOR
  803. K153073UroNav (Version 2.0)
  804. K973328INTERSOURCE
  805. K240871Synxess Neurovascular Guidewire
  806. K903742ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
  807. K920595ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER
  808. K896450NEURO N 50 LESION GENERATOR
  809. K851409UNILOC TOTAL HIP PROSTHESIS
  810. K951222TOTAL PROTEIN (URINE)
  811. K9549003M RED DOT ECG LEAD WIRES A
  812. K780065ULTRACHEM E-GLU, MANUAL DETERM.
  813. BK090058Automated Blood Cell Separators
  814. K853439MODEL 43130A DEFIBRILLATOR
  815. K072089ARTHROCARE SPINEWAND
  816. K003760TAI-CHI ACUPUNCTURE NEEDLES
  817. K964879PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY ARTHROSCOPY PULSED…
  818. K843130SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
  819. K150296Biodenta Customized Abutment-Hybrid
  820. K960160SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM
  821. K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
  822. K884156HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
  823. K935840TL 20W/12/RS & TL 40W/12/RS
  824. K003069ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
  825. K911937OSTEOMED IB DRILL
  826. K200278CytoCore
  827. K935036HEPA FILTERED HEAT AND MOISTURE EXCHANGER
  828. K130951SIM
  829. K9460253M X-LARGE SHEET #7979/ #7979NS
  830. K811970AP X-RAY TUBE ANGULATION DEVICE
  831. K761267ANGIOTENSIN I IMMUTOPE KIT
  832. K921902PORT ACCESS NEEDLE
  833. K792581GENERAL ELECTRIC PANELIPSE LD
  834. K881563TRYPTOSE PHOSPHATE BROTH
  835. K837481BF24 DOPPLER MODEL P872 AND P874
  836. K840273LOPEZ LOCK
  837. K002531EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3
  838. K983657OSTEONICS SERIES 7000 AD TIBIAL TRAY
  839. K992683MODUS 2.5 MANDIBULAR TRAUMA SET
  840. K240597TERA HARZ CLEAR
  841. K945962BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY
  842. K964945INNOVASIVE DEVICES ROTATOR CUFF FASTNER
  843. K952219SUCTION TIP CLEANER CUP
  844. K841703TDX REA LDH
  845. K091298LUBREASE FEMALE LUBRICANT
  846. K211088Grosz Play Feel
  847. K202294Affirm Contrast Biopsy
  848. K913530LOOK VISCODISSECTOR
  849. K827069PODIOSCOPE BY ARROW
  850. K902336CIBA CORNING ACS:180 AUTOMATED CHEMILUMINESCENCE
  851. K810323ACRYTOL, MOUNTING MEDIUM
  852. K193405Simplant Digital Guide
  853. K071010TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS
  854. K022941MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING
  855. K810836DECALCIFIER II
  856. K812047IDS BETA-LACTAMASE DISC
  857. K253524Adaptos®Fuse Bone Graft
  858. K943874PRECISON THERMOPLASTIC COMPONENTS GAS AMPLING LINES AND CONNECTORS
  859. K954143HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
  860. K771980FEVER TESTER
  861. K913622HEMOPLUS
  862. K880719PHARMACIA B2-MICRO RIA
  863. K905223OCTA-HEX (TM) IMPLANT RESTORATION SYSTEMS
  864. K971674VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL…
  865. K901453QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD
  866. K841133THAYER MARTIN MEDIUM
  867. K903487SOLARSHIELDS ENCORE
  868. K883256BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM
  869. K153334Oral-B 5% Sodium Fluoride Varnish
  870. K983027TRIMETHOPRIM/SULPHAMETHOXAZOLE
  871. K993821VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT
  872. K011186POWDER-FREE STERILE SYNTHETIC VINYL EXAMINATION GLOVES
  873. K242228Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle…
  874. K212054Senhance Surgical System
  875. K130181GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
  876. K220456Elecsys FT4 IV
  877. K900572LYME IGM MICROASSAY
  878. K102617AUDIT MICROCV CARDIAC MARKERS LINEARITY SET
  879. K132329NIVATOPIC PLUS
  880. K812289CELESTIN DILATOR
  881. K053339ALLOFIX ANCHOR
  882. K9323898100 ANESTHETIC AGENT MONITOR
  883. K953246OCTOROLL
  884. K925608SCIMED ENCORE(TM) ADVANTAGE KIT/ESSENTIALS KIT
  885. K911854DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL
  886. K812084SPS DISK
  887. K060182TRUMPET VALVE HANDLE WITH 3-METRE TUBING, SINGLE SPIKE, 5MM CANNULA, TRUMPET VALVE HANDLE…
  888. K024356CLEARFIL SILANE KIT
  889. K183064TxTi IBF System
  890. K914988500 INFUSER
  891. K991137ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
  892. K911302MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
  893. K860600SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION
  894. K020677GAMMA 3 LAG SCREW
  895. K133474BIOSIGN FLU A + B, STATUS FLU A & B
  896. K822550SAFE LOCK TITANIUM ADAPTER SET
  897. K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM
  898. K081539DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
  899. K863912THE MMG 5 IN 1 CONNECTOR
  900. K132233K-PACK II NEEDLE - 27G X 3/4 THIN WALL
  901. K253914Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434)
  902. K230131ReShape Calibration Tubes
  903. K855100S.L.T. CONTACT LASER SYSTEM
  904. K924820HYPOGRIP(TM)
  905. K130056PATIENT MONITOR
  906. K852208PHACO-BAC STOP FILTER KIT
  907. K983274STARTRACK INFANT GRAPHICS MONITOR
  908. K930999SIEMENS MODEL 584-P-AI
  909. K082454MICROMYST APPLICATOR, MODEL 20-5000
  910. K241745Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy…
  911. K181091AxSOS 3 Ti
  912. K111655FLAATZ 760
  913. K182758MCI - CMF System
  914. K252260RELIEEV HSG Catheter (HSG7FA1)
  915. K001336DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
  916. K896196ARTHROSCOPY DISP. & REUSABLE SHAVER BLADES, RECHAR
  917. K052911ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM
  918. K900669HYPO-ALLERGENIC SURGICAL GLOVES
  919. K162099IBS Implant System II
  920. K243839Alteon® HA Femoral Stems
  921. K832847MEDI-JECT
  922. K770424OXYGEN TWMER, MODEL SST
  923. K821117SCISSORS STRAIGHT 5&1/2SHARP
  924. K222297CentriMag Pre-connected Pack
  925. K030302HBS HEADLESS BONE SCREW
  926. K173933Sorrento Bioglass Bone Graft Substitute
  927. K050752AESCULAP ORTHOPILOT 2 THA V 2.0
  928. K863390HYDROCOLLOID DRESSINGS - STERILE
  929. K980103ACUMED SUTURE ANCHOR
  930. K840986PREFILLED PULSATOR SYRINGE
  931. K890601STUART TITANIUM SURGICAL MESH
  932. K883079WWDS-005 HUMAN RECTAL PROBE
  933. K961938STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
  934. K892870PERITONEAL DIALYSIS CYCLER SET, W/5 PRONG MANIFOLD
  935. K001724STIMULAN -CALCIUM SULFATE BONE VOID FILTER
  936. K841534ACME DIGITAL INFANT SCALE-30
  937. K771599GAMMA CAMERAS -GXA-301 & GCA-402
  938. K880778MEDSURG ACUTE DIALYSIS TRAY
  939. K242776LimFlow V-Ceiver
  940. K0611703.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
  941. K900950GS-2000 MICRO SCISSOR, CURVED LEFT, 5MM
  942. K001162GOLDFINGER DEVICE
  943. K840438COMFEEL ULCUS SHEET
  944. K973773DAPELLE HAIR REMOVER
  945. K963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWS
  946. K862084E. T. TAPE ENDOTRACHEAL TUBE HOLDER
  947. K761157AMINOGLYCOSIDE (125I) RIA KIT
  948. K974586AURORA DIODE LASER SYSTEM
  949. K864224ABBOTT SPECTRUM GLUCOSE REAGENT
  950. K875368THE DDI SERODOT RUBELLA IGG TEST KIT
  951. K854616ENTERAL FEEDING BAG
  952. K260910EndoTool IV Cloud 1.0
  953. K180406Ellipse Ydun
  954. K780609MASK, ISOLATION
  955. K832393ENCODYNE 4 & VACUFIX 4
  956. K935458AUDIPHON, MODEL H-11
  957. K953236CYLINDER IMPLANTS HA, TP, GRADE 3
  958. K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit
  959. K030589MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
  960. K141224JIUYUAN POWDER-FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES
  961. K081814REPROCESSED ENT SHAVERS
  962. K981767QTEXX POWDERFREE LATEX EXAMINATION GLOVES
  963. K970095PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
  964. K241369LIJIA Night Guard
  965. K111622UNIMAX ANTI-FOG SOLUTION
  966. K844403MODEL FORCE 2 ELECTROSURGICAL GENERATOR
  967. K961262WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
  968. K781823ELECTRODE, MODEL 030-326
  969. K942922SELECTA 20/60 CHEMISTRY ANALYZER
  970. K102875CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY…
  971. K940072I.V. SET (20 DROPS/ML)
  972. K802010GUAZE SWABS CAT.#251-300 (SIZE & PLY)
  973. K250767Newclip Patient-matched instrumentation non sterile PSI
  974. K812499INFUSION PUMP
  975. K911120DECONTAMINATING MACHINES, LS-850, LS-76, DW/T-216, T-21
  976. K192627Laser Hair Growth Cap
  977. K201299HD Steth
  978. K020957ORACAM
  979. K854631ASSERT EO BIOLOGICAL TEST PACK
  980. K032016DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN…
  981. K850601MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR
  982. K171491R2P Destination Slender Guiding Sheath
  983. K812908ELECTRO-GONIOMETER
  984. K193607BOBBY Balloon Guide Catheter
  985. K153695Biomet Spine Fusion System
  986. K981401BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS
  987. K9745533M UNIVERSAL ELECTROSURGICAL PAD, SPLIT (9160) 3M UNIVERSAL ELECTROSURGICAL PAD (9130)
  988. K912300VS11
  989. K082326ZONARE ULTRA ULTRASOUND SYSTEM
  990. K120115ORTHOSIZE
  991. K240850EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems
  992. K821381IOL FORCEPS
  993. K855018DURAHESIVE WAFER WITH FLANGE
  994. K042876URS LP DIGITAL, MILLENNIUM, RADPRO
  995. K950281MESH MATRIX WOUND DRESSING
  996. K110274AUTODELFIA NEONATAL IRT KIT
  997. K011017PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS…
  998. K911430IDEIA(TM) CHLAMYDIA, MODIFICATION
  999. K851912LASER PREALBUMIN TEST
  1000. K073292MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM

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