Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K220513NITRO Interbody Fusion Cage System Family
  2. K781583PAPANICOLAOU STAIN :EA-50:
  3. K8002940.45% SODIUM CHLORIDE SOL./RESP. THERAPY
  4. K923428PANDA
  5. K883526PORGES STEPPED NEOPLEX DILATOR
  6. K100060EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475
  7. K811144ARIA II INSULIN RIA
  8. K120098STERILE DISPOSABLES FOR MER
  9. K121618BEL-GEN COLD STORAGE SOLUTION
  10. K950517HARMONY LINE PF
  11. K983350ILO292 DP ECHOPORT PLUS OAE SYSTEM
  12. K770708TYGON PAC-STOPCOCKS
  13. K012439DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
  14. K970147ELECSYS CALCHECK PROLACTIN
  15. K050046REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S
  16. K062558MESOSFOL SURGICAL FILM
  17. K180022Athena Cervical Plate System
  18. K052096NUBIC SPINAL IMPLANT
  19. K802712ENTERMED ENTUNIT
  20. K060471FSSB NYLON SURGICAL SUTURES
  21. K003209URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
  22. K062019RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
  23. K141426ELECSYS FOLATE III
  24. K925945MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT
  25. K193139ProVecta 3D Prime Ceph
  26. K790996C.C.F. FEMORAL DEBRIDEMENT PROBE
  27. K100850COWELL IMPLANT SYSTEM
  28. K163539Ez3D-i / E3
  29. K905007STANDARD BREAST BOARDS; DELUXE BREAST BOARD
  30. K965051HEARTPORT NEEDLE TROCAR
  31. BK960024Blood Establishment Computer Software and Accessories
  32. K941685DISPOSABLE FILTERED INSUFFLATION TUBING SET
  33. K803094COPPER SULFATE SOLUTION SP. GR.1.053
  34. K901936PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP
  35. K972451COREGISTRATION FUNCTION
  36. K834155UNIVERSAL PACK
  37. K812148ELECTRONIC STETHOSCOPE #S-50
  38. K923229MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE
  39. K243958Consolidated Operating Room Equipment (CORE) 2 Console
  40. K141824MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP
  41. K101220EXPLORER 4D TREATMENT PLANNING SYSTEM
  42. K861630NEUROSURGICAL INSTURMENTS (VARIOUS)
  43. K924754DERMAGRAN WOUND DRESSING
  44. K241502P-SCOPE
  45. K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser…
  46. K970814NON-STERILE ISOLATION GOWN
  47. K152612eSensor Warfarin Sensitivity Saliva Test
  48. K955235B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
  49. K952709PROTHESIS, CHIN, INTERNAL
  50. K895194LATEX PATIENT EXAMINATION GLOVES
  51. K844230RHINOMANOMETER A440 DIGITAL
  52. K072418OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER
  53. K182369gammaCore Sapphire
  54. K905800X-T AIR DRILL
  55. K940361AUROLITE 1C
  56. K162474Artemis
  57. K843563MSI SURGI-GRADE INCISION & DRAIN TRAY
  58. K884445MAXITHINS PANTY SHIELDS, DEODORANT
  59. K243513DCM (PW-DCM)
  60. K842113AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
  61. K833522NEURO SECTOR FIXATION DEVICE
  62. K951641NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
  63. K130861MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, READY-TO-USE (LINK)
  64. K140068CARDIOCHEK PLUS TEST SYSTEM, CARDIOCHEK HOME TEST SYSTEM
  65. K864866RESUBMISSION OF THE KLEERZIT REAGENT
  66. K254133ENTity USB Videoscope System
  67. K862681ULTRAMARK 1 ULTRASOUND SYSTEM
  68. K862451LUER LOCK SKIRT
  69. K800298USCI BIPOLAR BALLON PACING ELECTRODE
  70. K993194RUSCH MANUAL RESUSCITATOR BAG
  71. K930013CO2 INSUFFLATOR 1100
  72. K910422MODEL RD-1200 RUBY LASER SYSTEM
  73. K801633THE BRAVO NEW PARALLEL FLOW DIALYZER
  74. K980726ULTRA-BLASTER
  75. K820024DIGITAL CLINICAL THERMOMETER
  76. K844892SLT 220 WASHER FOR MICROITITERPLATES
  77. K151693Dr-Ho's Foot Pad Electrode
  78. K970657LMI THROMBECTOMY CATHETER
  79. K211328EIDON FA, EIDON, EIDON AF, EIDON UWFL
  80. BK150301Device, Warming, Blood and Plasma
  81. K952533SIENET DICOM GATEWAY
  82. K851082V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
  83. K180576Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure…
  84. K890827IL1400, BGELECTROLYTE ANALYZER
  85. K161622LensGiene Sterile Saline Solution
  86. K112345DISTAL VOLAR RADIUS PLATING SYSTEMS
  87. K013342EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.
  88. K203566Tablet Application
  89. K874564MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
  90. K812364PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
  91. K974304GERMICIDAL CLOTH
  92. K894783PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP
  93. K132902SYNGO DUAL ENERGY SOFTWARE PACKAGE
  94. K251326Respiration Rate algorithm
  95. K243632uWS-Angio Basic
  96. K832712FOLATE RADIOASSAY KIT CA-1562-125
  97. K951319ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800…
  98. K935816VIDAS T UPTAKE
  99. K905661SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
  100. K972317MONTGOMERY THYROPLASTY IMPLANT SYSTEM
  101. K791360KODAK ORTHO M FILM
  102. K192301BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
  103. K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS
  104. K791591MOTILITY TEST MEDIUM
  105. K870225PERMOBIL EXTERIOR
  106. K984034THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED…
  107. K961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
  108. K992278HEPARIN CONTROL PLASMA LEVEL 1
  109. K802171KODAK ORTHO L FILM
  110. K813221TOXOELISA TEST KIT
  111. K242576AllTest Viral Transport Medium
  112. K102847DISPOSABLE ENDOMETRIAL SUCTION CURETTE
  113. K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE…
  114. K981266AUTO-INJECTOR, SURE-INJECT 2000
  115. K900509NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH
  116. K193642Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System
  117. K061381LC STAR WITH NASAL ADAPTER
  118. K152508Ageless Health Medical Digital Thermometer
  119. K163078DC-UIBC-CAL
  120. K892075MEDLINE LATEX EXAM GLOVES
  121. K223812Sensis Vibe (VD15)
  122. K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
  123. K770562HANDLER CATHETER
  124. K802667ARGYLE CLOSED URINARY DRAINAGE SET
  125. K201833BiPad Hand Activated, Disposable Bipolar Electrocautery Cords
  126. K151598VesselNavigator Rel. 1.0
  127. K812580MEDTRONIC MODEL 2409
  128. K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
  129. K944751COULTER FLOW SET
  130. K831345RIANEN PROLACTIN 125I KIT
  131. K982836CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
  132. K844101CARDIO-NEC MODEL 365
  133. K040670MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE…
  134. K121946AXIS-SHIELD ACVTIVE-B12
  135. K100520NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
  136. K122791LYOPLANT ONLAY
  137. K822682ANTI-NATIVE (DOUBLE STANDARD) DNA TEST K
  138. K121006ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
  139. K982787ASTEION CT SCANNER, TSX-021A
  140. K161554ENDOFLATOR 40, ENDOFLATOR 50
  141. K891615SURGICAL DRILLS
  142. K904843OSCAR(TM) II CAPNOMETER & PULSE OXIMETER
  143. K063771GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
  144. K973384ETHICON NON-STICK BIPOLAR FORCEPS
  145. K041090HDL-EX SEIKEN ASSAY KIT
  146. K132960BIOMONITOR
  147. K791668ENDOSCOPIC CYTOLOGY BRUSHES
  148. K820313VPI-FAIR URETHRAL STENT
  149. K242044FiAPC plus probes
  150. K040169SYNTHES MANDIBLE EXTERNAL FIXATOR
  151. K790020SERUM, LACTIC DEHYDROGENASE
  152. K983262FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
  153. K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho…
  154. K223365RODIN Palette Naturalizing Kit
  155. K052906ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
  156. K935434OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT
  157. K915280FEMOSTOP
  158. K102964EU-TTG IGA AND EU-TTG IGG
  159. K163150ViMove2
  160. K001430RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
  161. K994405INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
  162. K160589Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
  163. K123184FINN CHAMBERS AQUA
  164. K945906SILICONE PUNCTAL PLUG
  165. K192332ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath
  166. K060011MIIG SR
  167. K111254RELIEVA SOLO ELITE SINUS BALLOON CATHETER
  168. K183638SmartLinx Vitals Plus Patient Monitoring System
  169. K993758PROAIR 3000 COMPRESSION SYSTEM
  170. K010142OCO DENTAL IMPLANT
  171. K760316REGULATORS, LOW SUCTION
  172. K920418IL TEST CANNABINOID, 35282
  173. K760821REAGENT SYSTEM
  174. K871132PHARMACIA DELTEC SUBCLAVIAN INTRODUCERS
  175. K090819ONTEX TAMPON (UNSCENTED)
  176. K962012ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER
  177. K120117CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM
  178. K910043TENONE(TM) METHAMPHETAMINE
  179. K083378SYNERGY
  180. K081978RELIANCE SPINAL SCREW SYSTEM
  181. K913311SAFETY INJECTION PORT, MODIFICATION
  182. K853979CARDIMAX FX-1164
  183. K053212RAVEN PROPACT
  184. K942546CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER
  185. K980683TROVAFLOXACIN 10G, SENSI-DISC
  186. K051911GELITA-SPON
  187. K894552'MED-TECH' LATEX EXAMINATION GLOVE
  188. K946307CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE
  189. K791173SURFLO INJECTION PLUG
  190. K973851ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M12/630
  191. K870404COLORED CASTING TAPE (RED AND BLUE)
  192. K022569PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
  193. BK140191Bone marrow processing device to support hematopoietic reconstitution
  194. K953568CODMAN FIDUCIAL MARKER SYSTEM
  195. K884219BRACKET TABLE ARM COVER
  196. K200979DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System
  197. K903960MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
  198. K230292Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
  199. K041074BD FACSCANTO WITH BD FACSANTO SOFTWARE
  200. K990239COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
  201. K050620READMYHEART, MODEL RMH3.0
  202. K890509INDIRECT OPHTHALMOSCOPE ACCESSORY DELIVERY SYSTEM
  203. K051089GII SPINAL FIXATION SYSTEM
  204. K252155AVAVA™ Skin Treatment System
  205. K081236K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
  206. K871262MODIFIED NOFLO I
  207. K973430KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
  208. K932823BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
  209. K042308SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL…
  210. K011527PRAXSYS RELIA TSH TEST
  211. K834549EMIT ST. URINE COCAINE METABOLITE
  212. K882338MODEL #716 ADULT STIM. PADS LOW IMPEDANCE GEL TYPE
  213. K982728NELLCOR PURITAN BENNETT UNIPROBE ADAPTER CABLE, UP12A, UP12B, UP12C
  214. K850314TELEVISION CONTROL OPTION 1220
  215. K150691Datalys Multi-Parameter Patient Monitor
  216. K230530SOZO Pro
  217. K964279SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC)
  218. K032369MODIFICATION TO: APEXPRO TELEMETRY SYSTEM
  219. K200450X-Cube 70
  220. K153222Leva Spacer System
  221. K800734RAPID FERMENTATION AGAR (RFA)
  222. K253102GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
  223. K984607PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM…
  224. K922113KENDALL CURITY CONTINUOUS EPIDDUAL ANESTHESIA CATH
  225. K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System…
  226. K101572IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
  227. K922003ANTIMICROBIAL SUSCETIBILITY TEST PANEL
  228. K002973EMBOL-X INTRODUCER, MODEL CF00200
  229. K122919DIGITAL FLAT PANEL X-RAY DETECTOR11417PCA
  230. K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…
  231. K222298Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With…
  232. K851209CILCO/UNITED SONICS PHACE PF-9000
  233. K842570LUDLUM 88 DOSE CALIBRATOR
  234. K192051THINQ
  235. K915828INJECTION SITE WITH LUER LOCK
  236. K041268SILVERSITE OR CALGITROL
  237. K980144HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
  238. K883621INSTRUMENTARIUM ULF MR IMAGING SYSTEM
  239. K822767UNIVERSAL DYNASPLINT
  240. K061176STRAUMANN DENTAL IMPLANTS
  241. K791220FLOWMETER, BACK PRESSURE COMPENSATED,
  242. K980110ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM
  243. K193482PrisMax System Version 3
  244. K892129EZ COMPLEMENT C4
  245. K843067TCA HEARING AID
  246. K000231TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
  247. K874755EFFNER FE-EX* OROGASTRIC
  248. K945268OPTUS BRONCHOSCOPES
  249. K020487CARESIDE ALT
  250. K161295MiniBox +
  251. K922187COMPACT SPACER
  252. BK150279Blood Establishment Computer Software and Accessories
  253. K102114MEDRANGE ELECTROSURGICAL GENERATOR
  254. K901454VENA CAVA FILTER
  255. K932459FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
  256. K853794NEOGUARD REFLECTOR
  257. K921287SURGICAL RETRACTOR
  258. K931443ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
  259. K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
  260. K173664Medtronic O-arm O2 Imaging System
  261. K192942ALLthread Titanium Suture Anchor
  262. K912661MATRX, PYRAMID TRIANGLE BANDAGE
  263. K821166KOLOR KODE TM
  264. K011402BIOPSY SITE MARKER
  265. K9011695 STRAIGHT SCISSORS
  266. K822044SERALYZER HEMOGLOBIN REAGENT STRIPS
  267. K930179TRACHEAL TUBE FIXATION DEVICE
  268. K142032MRI PATIENT MONITORING SYSTEM TESLA M3
  269. K031359S-MONOVETTE EDTA K2-GEL
  270. K023815C-1805M
  271. K000985MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM…
  272. K892240PATIENT EXAMINATION GLOVES (LATEX)
  273. K854526VITALOGRAPH COMPACT
  274. K980803STERILE POWDER-FREE LATEX EXAMINATION GLOVES
  275. K790536CLEARVIEW
  276. K243640Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
  277. K923838THE ULTIMATE RCS ARCH WIRE
  278. K083073THEKEN ATOLL CERVICO-THORACIC SYSTEM
  279. K210441Incontinence Probe
  280. K864072ADEC 1005-C CHAIR
  281. K150369SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…
  282. K112407SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS
  283. K150607Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
  284. K080118ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE
  285. K862301IL SYSTEM 810, ACL AND THE REAGENT SETS
  286. K953777SYNTHES WIRE MOUNT
  287. K231412CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
  288. K243150Nuance Audio Hearing Aid Software
  289. K954230SORBSAN PLUS TOPICAL WOUND DRESSING
  290. K961828LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688)
  291. K003916DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
  292. K251109SMARTDent
  293. K092171VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
  294. K230057Acumen Hypotension Prediction Index (HPI) Algorithm
  295. K032026LCD MONITOR, RADIFORCE G11, G31, G51
  296. K083747TERUMO PALL AL3X ARTERIAL FILTER
  297. K222379Alinity m STI Assay
  298. BK950026Supplies, Blood-Bank
  299. K792302LS-100
  300. K992977HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
  301. K894090PATIENT EXAMIN GLOVES(MFG: SHANGHAI FACTORY)
  302. K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
  303. K250817Coretech Compression System (Coretech RHB3003)
  304. K820140WEBRIL CAST PADDING
  305. K092329SOPIX 2
  306. K875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN
  307. K032860IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA)
  308. K100841BONEOPTIMIZER
  309. K052310CRYOFLOW 700, CRYOFLOW 1000
  310. K193447Vista Dyes
  311. K896976MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS
  312. K982763SEARE BIOMEDICAL MALAR IMPLANTS
  313. K872251ABRASIVE DISC - POLISHING WHEEL
  314. K050717PROCLEAR ULTRAVUE TORIC, PROCLEAR ULTRAVUE MULTIFOCAL, PROCLEAR ULTRAVUE 200T MULTIFOCAL…
  315. K771759EXTEMP-V
  316. K863959OHMEDA 6000 MULTI-GAS MONITOR
  317. K821870ULTRAZYME PLUS ALP
  318. K895050100 SL (SILHOUETTE LINE) DENTAL CASTING ALLOYS
  319. K190132Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
  320. BK850020Supplies, Blood-Bank
  321. K812253GELMAN IG-FIX KIT
  322. K211336Disposable Vinyl Examination Glove
  323. K020902SERRALESTER
  324. K251727GLAM LED Facial Mask (TB-2386F)
  325. K871438BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52
  326. K924173HEMOCARD(TM) CONTROL
  327. K241461Mpact Constrained Liner
  328. K141725BONGOLD BONE GRAFT MATERIAL
  329. K030927POWDERED VINYL EXAM GLOVES, WHITE
  330. K990328DBC, DONG BANG ACUPUNCTURE NEEDLES
  331. K890560SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
  332. K002733SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM
  333. K252442Kii Structural Balloon Access System
  334. K092638FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22…
  335. K153436LATERAL Spine Truss System
  336. K061329INFINITY MASIMO SET SP02 POD
  337. K790961LIQUID SCINTILLATION COUNTER
  338. K842050IMPACT MODEL 316
  339. K920413DECOMAT A 8666
  340. K102567WATCH-PAT 200S-3 (WP200S-3)
  341. K895899FLEXMEDICS GUIDEWIRE .012 ONLY
  342. K926062ARTHROSCOPIC KNEE INSTRUMENTS
  343. K212055Connected OR Hub with Device and Voice Control
  344. K800253MYCOPLASMA SUPPLEMENT G
  345. K260222Mako Total Knee Application
  346. K221996P-Cure Proton Beam Therapy System
  347. K133533LOGIQ E
  348. K020539TIPOWER POWERDRIVE AND RIMPOWER X & SX
  349. K170593Mako Total Hip Application
  350. K912037DEGULUX LIGHT CURING UNIT
  351. K982154MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM
  352. K180206neuromate Gen III
  353. K170098ICONIX TT All Suture Anchor
  354. BK130028Test, Qualitative, for HLA, Non-Diagnostic
  355. K201069VibrantVue Scleral Saline
  356. K993157HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
  357. K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK…
  358. K860984TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT
  359. K022876MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
  360. K9550983M MINI-DRIVER ELECTRIC SYSTEM
  361. K033870IMAGE MANAGEMENT SYSTEM
  362. K102619COMPUTED RADDIOGRAPHY SCANNER
  363. K160339Cardinal Health Isolation Gown
  364. K260381Eve
  365. K993533POWERHEART AECD
  366. K981920AMM
  367. K243407Forcyte Autograft Harvest Kit
  368. K132581MICROCUTTER XCHANGE 30, MICROCUTTER XCHANGE 30, BLUE STAPLE CARTRIDGE, BLUE STAPLE…
  369. K914991VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS
  370. K900675PHONAK ITE 8000, 7000, 6000 ITE HEARING AID
  371. K041296MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO…
  372. K934834EPTFE SHEET COVERING FOR OCULAR IMPLANT
  373. K080579EFFECTIV (TM) CAP
  374. K190016Lateral Plate System
  375. K823243SIDEARM Y-ADAPTOR
  376. K933400KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR
  377. K834031FACTOR II DEFICIENT SUBSTRATE PLASMA
  378. K260870Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
  379. K081730NOVEL CERVICAL SPINAL SPACER SYSTEM
  380. K120743SPECULUM, VAGINAL, NONMETAL
  381. K100902AEDIS(TM)
  382. K122159DORNIER MEDILAS H30 SOLVO
  383. K221264FROG Forceps Valve (VAL1-F1-100)
  384. K942180KEELER MULTILASE 3000
  385. K882114AMISCO U-100 INSULIN SYRINGE
  386. K844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH
  387. K920337MILES LIPASE SERA-PAK METHOD
  388. K935453CONSENSUS(TM) HIP SYSTEM-HA COATED TIANIUM FEM STEM
  389. K133173RUSCH TRACFLEX PLUS PEDIATRIC TRACHEOSTOMY TUBE SET
  390. K121396DYNAFLEX
  391. K010024O2/CO2 NASAL FILTERLINE
  392. K952309N LATEX IGA
  393. K122591CLYDESDALE SPINAL SYSTEM
  394. K831537PARAMAX CREATINE KINASE REAGENT
  395. K840465Q-MED ELECTRODE
  396. K023405TROJAN MINT TINGLE BRAND LATEX CONDOMS
  397. K130675ARTHREX UNIVERS II CA HEADS
  398. K062341MALE REMEEX SYSTEM
  399. K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS
  400. K023413MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM
  401. K951930CEMENTRALIZER DISTAL STEM CENTRALIZER
  402. K131141EARPROBE
  403. K023688LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
  404. K191214JO Premium Jelly Original Personal Lubricant
  405. K990091S.P.A.R STERILE AMBULATORY RESERVOIR
  406. K895815MICROTEK TOTAL OSSICULAR PROTHESIS
  407. K171086Accuray Precision Treatment Planning System
  408. K933934GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A
  409. K110056AFINION ANALYZER
  410. K140195SURGICAL DRAPE
  411. K130566BASIXTOUCH
  412. K182938Emission Computed Tomography System
  413. K181185Change Healthcare Enterprise Viewer
  414. K811957CAMPYPAK
  415. K811092STERILE PACKAGING
  416. K812962BOUNDARY SURGICAL DRAPE
  417. K823644FINGER FLEXION SPLINT
  418. K031713AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
  419. K011516INFANT FLOW SYSTEM, MODEL M672P
  420. K935510VX4 RECORDING PULSE OXIMETER
  421. K031339OPTIBOLUS
  422. K834002LYSINE IRON AGAR
  423. K103287SYNTHES 6.0 COCR AND CPT TI-3 RODS
  424. K153087IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System…
  425. K211252Nitrile Glove
  426. K901545GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM
  427. K944052RASCAL-II RESPIRATORY AND ANESTHETIC GAS MONITOR
  428. K934185TROCAR REDUCER WITH GAS CLHECK VALVE
  429. K052683SYNTHES (USA) STERNAL FIXATION SYSTEM
  430. K834305ARGON/KRYPTON ION LASER PHOTOCOAGULA
  431. K020171COOLBLU2 DENTAL RESIN CURING DEVICE
  432. K883370FISCHER'S MEDIUM CATALOG NO. 210-4007
  433. K834566PRESERV SAF FIXATIVE 15ML
  434. K980782STAT-SIMPLE PYLORI
  435. K862983ADDITIONAL TARGET THERAPEUTICS GUIDE WIRES
  436. K033534VITALSENSE
  437. K251101AIRO Suction Unit (AIRO-01)
  438. K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE…
  439. K811586F72T12/BL-S/SHO-O UVA SUNLAMP
  440. K955889POWDERFREE LATEX EXAMINATION GLOVES
  441. K201592Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
  442. K171460Powder-free Clear Vinyl Patient Examination Gloves
  443. K930084MICRO-ARTHROSCOPE
  444. K981419TC SERIES (TILT RECLINER)
  445. K121031WAVELIGHT FS200 PATIENT INTERFACE 1505
  446. K203595DynaFuse Fixation System
  447. K070833ATLANTIS ABUTMENT FOR ASTRA IMPLANT
  448. K170595IV Administration Sets
  449. K110404EAUM TOTAL KNEE SYSTEM
  450. K820716MONOJECT 512 SYRINGES W/WO NEEDLES
  451. K210931Libby IAAA v1.0
  452. K042340KASIOS TCP
  453. K940847ENDOSCOPIC PLANTAR FASCIA KIT
  454. K111378OXIMETRY INTERFACE KIT
  455. K800889TRICYCLIC ANTIDEPRESSANT II TX CONTROL
  456. K141746AS20 COMPOSITE GRAFT
  457. K111725MOBILEDIAGNOST WDR
  458. K143355The Simple Locking IntraMedullary (SLIM) System
  459. K160157LOSPA Modular Knee System
  460. K202337Pulsed electromagnetic field wrap
  461. K922703THE ACTA FORMULA
  462. K902220PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL
  463. K931074DU PONT MV DARKROOM CASSETTE
  464. K792341PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
  465. K821080HAND KERATOSCOPE
  466. K242195Gemini Cervical Fusion Cage System
  467. K102802INTEGRA ELECTRODE TUNNELING NEEDLE
  468. K092810EP-WORKMATE SYSTEM, VERSION 4.2
  469. K001596LIFERX
  470. K140897SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL
  471. K854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS
  472. K823436MICROSURGICAL GAUGE
  473. K102968INFINITY CNAP SMARTPOD
  474. K896044CROSS CANCELLOUS BONE SCREW
  475. K952553ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE
  476. K964707SOLDER 585
  477. K142810WEGO-PGCL Absorbable Surgical Monofilament Suture
  478. K828619OHMICRON MAMMOGRAPHY X-RAY SYSTEM MODEL OMC 4520M
  479. K883124AMERLITE FREE THYROID CONTROL SERA LAN.4002
  480. K080085MAS TOX CONTROL
  481. K851624MODEL TT-185 TELEMETRY TRANSMITTER
  482. K022214MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
  483. K900783MDI ADAPTOR
  484. K093951OUCHLESS MODEL PN10114
  485. K040234LASERPRO CO2 CARBON DIOXIDE LASER SYSTEM
  486. K971575BENCHMARK-IV
  487. K810144ALK-PHOS BIOPAK GEL
  488. K130707ISIRONA MAGELLAN
  489. K060763STRYKER INJECTABLE CEMENT
  490. K151147STARband, STARlight
  491. K012563DEEP GRAY
  492. K210637CD Horizon™ Spinal System
  493. K041736PFA PATCH
  494. K141400DCCERAM SYSTEM
  495. K160876PC ECG
  496. K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIE
  497. K760159AGGREGOMETER, DUAL CHANNEL PLATELET
  498. K972801ALLIANCE RUBBER, EC-GRIP
  499. K242111VIVACE
  500. K262649Alians Forearm
  501. K881693TERUMO SENSIBEAD EIA PROGESTERONE KIT
  502. K090469CARESTREAM DRYVIEW 5850 LASER IMAGER
  503. K893038PROTOFLUOR Z
  504. K982168SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
  505. K924213ECLIPSE 2100(TM), MODIFICATION
  506. K944667LIFE PULSE TESUSCITATION TIMER
  507. K913578MILESTONE MS 525 RADIOGRAPHIC X-RAY GENERATOR
  508. K791777CORNING GLYCOSYLATED HEMOGLOBIN SET
  509. K802029OBJECTIVE REFRACTOR
  510. K012473VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
  511. K920104IDENTI LOOPS DEGANIA SILICONE
  512. K843919SPOTTEST LOEFFLER METHYLENE BLUE STAIN
  513. K840295AMBULARM
  514. K242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
  515. K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
  516. K912732FIRST CHOICE(TM)
  517. K140020HYPERQ ACS-100 SYSTEM
  518. K871396ACCULATOR 287EP
  519. K062998COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG)
  520. K984486PULSEMASTER DENTAL LASER SYSTEM
  521. K142948BIOSURE REGENESORB interference Screw
  522. K922354BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET
  523. K092233SURGIMESH XD
  524. K220956Libby Echo:Prio
  525. K950633CANDELA URETHRAL/BLADDER SOUND
  526. K113222ND LOWSPEED AIRMOTOR,ND HIGHSPEED AIRTURBINE HANDPIECE
  527. K972826ESTEEM 1.5T MRI SYSTEM
  528. K780040ALANINE TRANSAMINASE
  529. K182587Device Electrosurgical Generator ESG-150
  530. K801596CYNERGY MODEL 184
  531. K841009SURGICAL RETRACTORS-VARIOUS
  532. K9050834.5F IMAGECATH ANGIOSCOPE
  533. K170800NuVasive LessRay with Enhanced Tracking
  534. K250829Lacevo Wearable Breast Pump (Model S70)
  535. K103838FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
  536. K240168N7-S
  537. K191331Life Sensor Cardiac Monitor
  538. K942344ZOLL PD 1600 SEMI-AUTOMATIC EXTERNAL DEFIBRILLATOR
  539. K250556Porous Biologic Scaffold
  540. K000832STEROTACTIC LOCALIZATION DEVICE (SLD)
  541. K030605RAPID IMF
  542. K191233ARIETTA 750
  543. K122246MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12
  544. K811263TOX TM ANALYZER
  545. K982733OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE
  546. K922064MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE
  547. K854542TDX C-REACTIVE PROTEIN
  548. K932392PHX TECHNOLOGIES CORP ELECTROSURGICAL PROBES
  549. K902265FLEXIBLE SNARE
  550. K182732JTL-250-01
  551. K942850ZOLL POWERBASE(TM)
  552. K253017BloodSTOP iX Trauma Matrix (TM-iX-20)
  553. K213409ZEUS System (Zio Watch)
  554. K071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL
  555. K863560URESIL STD FLAT/ROUND & FLAT/ROUND SPLIT. SILI/DRA
  556. K250768Elecsys Anti-SARS-CoV-2
  557. K911739SWEMAC REISON BIPLANAR 300
  558. K831774LOGIPE A DATA REDUCSYSTEM IP SPECIFIC-
  559. K002853SCITON IMAGE HAIR REMOVAL LASER
  560. K240066Fine Osteotomy™
  561. K820859COAXIAL DUAL FLOW CATHETER
  562. K954372AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
  563. K913805MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER
  564. K863085COULTER COUNTER MODEL T-540
  565. K873509IDENTICULT-BL
  566. K912352PEACE MODEL 100 CUFF MONITOR
  567. K122449ENTERAL NUTRITION WARMER
  568. K132993COUNTER OTC TENS DEVICE
  569. K130212SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
  570. K892575VINYL PATIENT EXAMINATION GLOVES
  571. K051506MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT…
  572. K790407MICROTEC BACTERIAL FILTER
  573. K851916VSM MODELS A & B
  574. K890576KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
  575. K152297OBS Anchorage Screw
  576. K994326ASCENT KNEE SYSTEM
  577. K992556PERMACOL
  578. K180850re.t.a Reuseable Tampon Applicator
  579. K112857INTERFACE BONE VOID FILLER
  580. K193050Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
  581. K801936PAD, EXAMINING TABLE
  582. K092447DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
  583. K980957KAPLAN-SIMPSON INFUSASLEEVE II
  584. K960858GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
  585. K120151NEBULAE I
  586. K993023SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
  587. K981084URISCREEN
  588. K082546REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS…
  589. K963731TRU-5000 THERMAL RECOVERY RADIANT HEATING UNIT
  590. K851048CHEST CATHETERS/THORACIC CATHETERS
  591. K852060INFUSION SETS MODELS 9120,9121,9125, 9122 & 9123
  592. K790588ASSAY REAGENTS, LSA 290
  593. K936040HYPO(R) SAFETY CARTRIDGE SYRINGE
  594. K965154TST CONTROL INTEGRATOR FOR STEAM AUTOCLAVE
  595. K960882CONTROL SYRINGE
  596. K050049DYNAFLO BYPASS GRAFT
  597. K163201KYMCO EQ10D Scooter
  598. K173446Contour 24
  599. K810536ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB
  600. K202169Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
  601. K042268EBI CAS SPINE SPACER SYSTEM
  602. K023946ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE…
  603. K223542TubaVent Balloon Dilatation System
  604. K811141SECHRIST INFANT VENTRILATOR MODEL IV-100
  605. K913121OMNIFLEX OVERHEAD TUBECRANE CAT.#S-9108/#6713.400
  606. K060553RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE
  607. K900149POWDER-FREE VINYL GLOVES
  608. K093946HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2
  609. K101377SMITH & NEWPHEW ULTRABRAID II SUTURE
  610. K972418HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED…
  611. K07355918 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
  612. K833274DERMATOLOGY HANDPIECE-OPHTH LASER
  613. K190783Health Expert Electronic Stimulator (model: AST-300L)
  614. K090228ROC LUMBAR PLATING SYSTEM
  615. K163544Lumipulse G Prolactin
  616. K163294syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology
  617. K831431AUDIOMETER MODEL-500
  618. K101191NAVIAID ICVI DEVICE
  619. K954791SEMINAL FLUID COLLECTION KIT II
  620. K822844PENTAX BRONCHOFIBERSCOPE #FB-19E
  621. K082752QUICKPIN
  622. K792456PNEUPAC VENTILATOR/RESUSCITATOR #3
  623. K162702Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression…
  624. K252286BIORES Dental Implant System
  625. K810781L-GLUTAMINE
  626. K122174PEDIATRIC POSITIONER PAD SET
  627. K241625Anatase Navi Disposable Instrument
  628. K973168SMARTVIEW OPTIONS FOR HISPEED CT/I
  629. K203323Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
  630. K082833NBX - NON-BRIDGING EXTERNAL FIXATOR - SHOULDER
  631. K771047QUANTA-MATE VITAMIN B-12/FOLATE RA
  632. K223326Axiom PSR System
  633. K812013FLUORESCENT ANTIBODY CONJUGATE FOR GP.A
  634. K173198Facet Screw Fixation System
  635. K0417915.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)
  636. K961703COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION…
  637. K081081ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
  638. K914313HICOR
  639. K180515GammaTile
  640. K220976Life Scope PT BSM-1700 Series Bedside Monitor
  641. K760934HOSPITALITY SERVER
  642. K781713ADAPTER, C/D SUCTION
  643. K920788BLOOD ADMINISTRATION SET
  644. K093527ARIA RADIATION ONCOLOGY WITH MIRS
  645. K233183Surgical Gown (40083)
  646. K943692SMART DOSE(TM)
  647. K984278MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II
  648. K972403BTI CORTICAL BONE SCREWS
  649. K211063HALYARD Flexaprene Green Powder-Free Exam Glove
  650. K833138DIGITAL INJECTOR SYS
  651. K827796INNOSCAN EXAMINATION LIGHT
  652. K950280TDX(R)/TDXFLX(R) FREE PHENYTOIN II
  653. K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen Test
  654. K012147DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
  655. K182064ExpanSure Transseptal Dilation System
  656. K931201TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETER
  657. K152996Molteno3 Glaucoma Implant
  658. K170421ET Hybrid Abutment
  659. K933570RESOLUTION(TM) HIP STEM
  660. K834588OXYMIZER-PENDANT
  661. K871807BARD MICROINFUSER I INSULIN INFUSION PUMP
  662. K974429RAPET CRP
  663. K955716VANCOMYCIN FPIA REAGENT SET
  664. K052273POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
  665. K202928DV. Target
  666. K882867CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE
  667. K901078SINGLE-USE, STERILE 4OZ BOTTLE CONTAIN 0.9% SALINE
  668. K173244superDimension Navigation System V7.2
  669. K861646BIO-CARB D16000, D16001, AND D17000
  670. K932778BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER
  671. K181586Tinnitus Sound Generator Module
  672. K932216C-SECTION, LABOR & DELIVERY TRAYS (PACKS)
  673. K810742AQUEOUS TRIOLEIN STANDARDS & KITS
  674. K831289PREFILLED IEC COLUMNS
  675. K803260SENSOMAT MUSCLE/TISSUE PH
  676. K082773STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331
  677. K032441F-10 FOLDING POWER CHAIR
  678. K902762PM14 SOFT AIR COMPRESSOR
  679. K121637AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE
  680. K872311ABBOTT A-GENT LIQUID MAGNESIUM REAGENT
  681. K021610QAB2A IGM ELISA KIT HRP
  682. K051535MODIFICATION TO:REGISTRADO X-TRA
  683. K954523THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
  684. K051533I-STOP
  685. K162427Vado Bi-Directional Steerable Sheath
  686. K101816STN PROBE
  687. K041861NEXUS INTRAVENOUS TUBING SETS (NIVTS)
  688. K963830SHARPS CONTAINER MODEL# SC001
  689. K964251OCCLUSION CLAMP** DEVICE
  690. K133105BREEZE NEBULIZER (NBR-10X)
  691. K820307TECNOMED GENERATOR, RADIOGRAPH., 3 PHASE
  692. K022066REGISTRADO X-TRA
  693. K801469BONN MICRO IRIS HOOK (NON-STERILE) #7613
  694. K822762CLINICAL GAS MIXTURE-FLAMMABLE
  695. K800303ELECTRONIC PERINEOMETER
  696. K922913EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS
  697. K821418TRYPTOSE BLOOD AGAR W/5% SHEEP BLOOD
  698. K031915PULPDENT ETCH-RITE ROYALE
  699. K161369EVEREST Spinal System
  700. K910607PACIFIC MARQUIS SPA
  701. K032817EXTERNAL DRAINAGE SET
  702. K233709Exceed Unlimited
  703. K792159FISCH DRILL SYSTEM
  704. K002070BIOLOK SCREW
  705. K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant System
  706. K961559SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
  707. K905655NONABSORBABLE POLYPROPYLENE SURGICAL MESH
  708. K024340SMITH & NEPHEW FEMORAL HEADS
  709. K991693TWO RIVERS POWER LIFT/RECLINE CHAIR
  710. K860755KODAK MIN-R FAST SCREEN SO-459
  711. K072000APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
  712. K941526MODEL 2000 MILD INTERMITTENT SUCTION PUMP
  713. K945580DSP OPTION
  714. K770248ARGYLE RAPID GASTRIC LAVAGE KIT
  715. K082086KEY RING ALCOHOL BREATHALYZER
  716. K954997CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
  717. K243171Yushan X-Ray Flat Panel Detector
  718. K053585VANGUARD REPROCESSED SUTURE PASSER
  719. K110295INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
  720. K844638ELECTROCAINE MODEL SR-IV
  721. K130652VITALITE E CROSS-LINKED POLYETHYLENE ACETABULAR INSERT
  722. K894290ACCESS TM
  723. K943125QUADRASPHERIC FUNDUS LENS
  724. K202927EYE-SYNC
  725. K202087DIXI Medical Microdeep Micro-Macro Depth Electrodes
  726. K881756STERILE SURGEONS GLOVES
  727. K853463LX EMBEDDING CENTER
  728. K033113UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER…
  729. K993926OMNIAXIAL CONNECTOR
  730. K063650VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
  731. K963733NICCHECK I
  732. K193303Tinnitus Sound Generator Module
  733. K243426Nurochek-Pro System
  734. K160260Tempo Temporary Pacing Lead
  735. K040359HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
  736. K953863HICHEM ISE STANDARDS KIT 70011
  737. K072713ION DENTAL RESIN SYSTEM
  738. K243419Altus Spine Navigation System
  739. K232185SM-IV
  740. K070357FLEXCATH STEERABLE SHEATH & DILATOR
  741. K033978ADAM
  742. K033505RENACLEAN SH DIALYZER CLEANING SYSTEM
  743. K853461COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA
  744. K180545VACUETTE SAFELINK Holder with male luer lock
  745. K883300IRRIGATION SET
  746. K911069VERSA-STIM ELECTRODE LINE MODIFIED
  747. K043191REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG…
  748. K770096EPIDURAL BLOCK PROCEDURE PACK
  749. K051093OSTEOPORE PCL SCAFFOLD
  750. K897008MENSTRUAL TAMPON
  751. K131260NMI DIALYSIS CATHETER
  752. K072546SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM
  753. K761312ORTHOTIC BRACING
  754. K810088URIC ACID (TPTZ) COLORINMETRIC
  755. K992961LORENZ SMALL FRAGMENT SYSTEM
  756. K915697CRITIKON VITAL SIGNS MODULE
  757. K810483FALLOPIAN TUBE FORCEPS
  758. K003922NITRILE EXAMINATION GLOVES (POWERED)
  759. K121536INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
  760. K760675ELECTROSURGICAL DISPERSIVE PLATE
  761. K963363HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
  762. K823321DENTAL INSTRUMENTS - CARVER
  763. K080219MODIFICATION TO:NESS L300
  764. K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0
  765. K121165BEAM BRUSH/BEAM APP
  766. K172278Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
  767. K961759CEMENT AND BONE REMOVAL KIT
  768. K110934ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
  769. K202757CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50…
  770. K871876MODEL 5050 SURGILASER FOR PULMONARY USE
  771. K981214OSTEOGRAF/N-700
  772. K962033CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
  773. K822786MDM ARTERIAL BLOOD GAS KIT
  774. K182766Cufitec Surgical Mask
  775. K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
  776. K984246PROMPT L-POP
  777. K033054HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP
  778. K863124MODEL 8 EEG PREAMPLIFIER
  779. K083756GUARDIAN 150 ELECTRODE
  780. K183208Suprasorb A + Ag “R”
  781. K950243TITAN INSUFFLATION NEEDLE
  782. K242061Reusable Interface Cable 1.5 m (PRD-IFC-002)
  783. K160967Finapres Nova Noninvasive Hemodynamic Monitor
  784. K090676MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES
  785. K190107VeriSplint
  786. K991304HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
  787. K990042SILON DUAL-DRESS
  788. K243182Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
  789. K092250MEDLINE RED RUBBER URETHRAL CATHETER
  790. K250508AK 98 Dialysis Machine (955607)
  791. K791046ENDOTRACHEAL TUBES, LONG & SHORT TERM
  792. K220133Sterilization Wraps
  793. K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec…
  794. K860580ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
  795. K905098ELEGANCE GH ELISA
  796. K910557BARRIER* EXTRA PROTECTION PLUS FACE MASK
  797. K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CR
  798. K212755SIGNUS SACRONAIL® Transsacral Stabilization System
  799. K890704BTE HEARING AID OTICON MODEL: E42P
  800. K950324MULTI-WASH
  801. K901485ENZYGNOST ANTI-CMV/IGG + IGM
  802. K160171Illuminated Mediastinal Access Port
  803. K861916ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
  804. K131753MERIDIAN
  805. K141654THE BELMONT RAPID INFUSER
  806. K884819O'NEIL URINARY CATHETER INTRODUCER
  807. K990372MODULAR INSTRUMENT SYSTEM FOR MINIMAL INVASIVE SURGERY
  808. K113218PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
  809. K801392DISPOSABLE SUMP SETS
  810. K802493SPUTASOL
  811. K810754LUTENIZING HORMONES
  812. K894722RENNER-PLAN
  813. K052204THE ELITE - ULTRA-LIGHT, COMPACT PORTABLE SCOOTER
  814. K130380ORTHOSENSOR KNEE BALANCER
  815. K910148AM130 AGC-O (BEHIND THE EAR) HEARING AID
  816. K192485BioCode Respiratory Pathogen Panel (RPP)
  817. K120282CARDNAV
  818. K220271Hand Diagnostic Radiography Imaging System
  819. K792284CULTURIA EMB/COLUMBIA CNA W/5% SHEEP
  820. K241627Safety Lancet (XXXV)
  821. K853513DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY
  822. K090976VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS
  823. K884081INTERIM, TEMPORARY CEMENT
  824. K220607BD MAX Enteric Viral Panel
  825. K943676DANEKSCOPE OPTI-PROBE
  826. K822598TEFLON PIGTAIL/PERCUTANEOUS CARDIOVAS
  827. K060103ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS
  828. K001901POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL…
  829. K831167ENTERAL PUMP SET
  830. K771191HEISS RETRACTOR
  831. K092089CLARUJUST
  832. K171765Nihon Kohden CO2 Monitor
  833. K170967Intraskan DC Plus
  834. K170571Tyber Medical BioTy(TM) Nanotopography Trauma Screw, TyFix Screw
  835. K840575SPOTTEST OXIDASE REAGENT
  836. K915445MAALEABLE FACIAL IMPLANT
  837. K904886VASCULAR ACCESS PORT CONTINUOUS INFUSION SETS
  838. K883200CANON AUTOREFRACTOMETER R-22
  839. K863017ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAX
  840. K920718DISPOSABLE POSTERIOR MICROSCISSORS
  841. K823835SPEMBLY 140 CRYOSYSTEM PROBES & TIPS
  842. K950393ACE(TM) CEDIA(R) FERRITIN ASSAY
  843. K992234THE TAPER-FIT TOTAL HIP SYSTEM
  844. K802836SERIES 1800 EXERCISE TREADMILL
  845. K924554CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE
  846. K191401PregSense
  847. K935422SUNLOVERS, CHARLES JOURDAN, COURREGES SUNGLASSES
  848. K013225INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
  849. K945706BONE DRILL
  850. K972416MOMO DESIGN OR MOMO
  851. K992620BLULAZE
  852. K893895HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL
  853. K811290ARACHIDONIC ACID
  854. K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…
  855. K963387DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP
  856. K200757Foley Catheter with Temperature Sensor
  857. K820579FLEX-E1 ECG ELECTRODE
  858. K952674TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA
  859. K182219SGS Dental Implants System
  860. K822185LARYNGEAL SYRINGE
  861. K232091JO Coconut Hybrid Cooling Personal Lubricant
  862. K801613MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
  863. K860446C ARM SURGICAL TABLE
  864. K220426Fiber Dust PRO
  865. K002483POWER 5000 GENERAL PURPOSE COIL
  866. K253146Hyperdrive 35 Guidewire
  867. K771183TOOTHBRUSH, PEDODONTIC, #0126-0188-00
  868. K932505RI-STAR
  869. K971211DISPENS-O-DISC SPARFLOXACIN
  870. K871512SL-100 ND:YAG LASER FOR GYNECOLOGY USE
  871. K102604I-LOGIC INREACH SYSTEM
  872. K874921HEADFIRST (CONDOM)
  873. K210993CereLink ICP Monitor
  874. K910835BACTEC NR-860
  875. K980417MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK…
  876. K212306Tapestry Biointegrative Implant
  877. K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT…
  878. K173403GEM Premier 5000
  879. K953979APOLIPOPROTEIN CALIBRATOR (APO-CAL)
  880. K022588HRW-63-INT WRIST ARRAY COIL
  881. K781523PFT GASES
  882. K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter
  883. K221720Extra Silver Gelling Fiber Dressing
  884. K830245HEAD HALTER
  885. K883783TSRH SACRAL SPINAL SCREW
  886. K181143Keeler TonoCare Tonometer
  887. K770680HEMATRAK
  888. K853895AUDTEX 85
  889. K834569VENTILATORY FREQUENCY MONITOR
  890. K102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
  891. K982066MP-3 POWER BASE CHAIR
  892. K150438Force Fiber OrthoTape suture
  893. K870897KODNER ANAL PERIONEAL RETRACTOR
  894. K122347ELISIO-H AND ELISIO-M HEMODIALYZERS
  895. K790265LEVO-STAND-UP WHEELCHAIR
  896. K213777Stryker Resorbable Fixation System
  897. K021245DEGOTZEN SYNCHRO
  898. K143107DLP Vein Graft Cannula
  899. K844601UNSCENTED MENSTRUAL PAD
  900. K231874AOT & T-L Abutment
  901. K895402ENDOCOAGULATOR 2001 KLI
  902. K071410ARGEN PEARL BRAND ZIRCONIA
  903. K183321Treace Medical Concepts (TMC) Plating System
  904. K203455Disposable Medical Mask
  905. K061283PULMOLIFE
  906. K936294SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS
  907. K964656TEFGEN GUIDED TISSUE MEMBRANE
  908. K082861AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3…
  909. K823846URIC ACID TEST
  910. K861565SERIES TEN THOUSAND COMPACT
  911. K260669Endoform Dermal Template
  912. K173430SeQure® NF and SeQure® Microcatheters
  913. K791560GOAT ANTI-HUMAN C-REACTIVE PROTEIN
  914. K963447DOUBLE SUPPORT PONCHO/SLIDER PONCHO
  915. K032950GEM INSET PATELLAR COMPONENT
  916. K011551SURE CHECK PREGNANCY TEST
  917. K850079NOW HOME PREGN. TEST KIT ENZYME IMMUNOASSAY HCG
  918. K103172CIV-OB (PLUS)
  919. K913302DISPOSABLE SPECIALTY SPONGES (DISSECTORS)/MODIFIED
  920. K161038PK Morcellator
  921. K141867ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
  922. K121310MESOTHELIUM DENTAL MEMBRANE
  923. K946164KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC…
  924. K823696MICRO Z BLOOD COLLECTING NEEDLES
  925. K954639SUNGLASSES
  926. K151020Rampart-T Interbody Fusion System
  927. K212912OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors…
  928. K921131CKS OSCILLATING SAW BLADE
  929. K151017JMS Harmony A.V. Fistula Needle Set
  930. K924093ELECTRIC HI LO TILT TABLE
  931. K081954GYRUS ACMI GENERAL SURGERY WORKSTATION, MODEL G400, AND DUAL FOOTSWITCH CONNECTOR CABLE
  932. K200283Medussa-PL Cage
  933. K922831QUANTA LITE SM ELISA
  934. K870015HCI ALL PURPOSE DRAIN/CATHETER SET
  935. K083865PILOT SPINAL SYSTEM
  936. K933503PRO-PHACO HANDPIECE
  937. K183077Delta Xtend Reverse Shoulder System
  938. K220512Disposable Surgical Face Mask (M01, M02)
  939. K861200UROTOPO CATHETER
  940. K093680DIAZYME CYSTATIN C ASSAY
  941. K250014Symani Surgical System (820-03830)
  942. K770363ACA AMMONIA ANALYTICAL TEST PACK
  943. K944249AUTO SUTURE* ANTI-FOG DEVICE**
  944. K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORD
  945. K910701ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
  946. K941147SPLASHMASTER OC EYE AND FACE PROTECTIVE PRODUCTS
  947. K923834TRACHEOSTOMY CARE SET WITH GLOVES
  948. K183343Vantage Total Ankle Flat Cut Talar Components
  949. K822740K30000 DENTAL CHAIR
  950. K042040TRIACTIV SYSTEM
  951. K101420GC FUJI TEMP
  952. K914792PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET
  953. K203331Quick-20m
  954. K911490LAPAROSCOPE SUPPORT ARM
  955. K093066I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
  956. K014155OPENING/CLOSING WEDGE OSTETOMY PLATES
  957. K903644SERIES 1500 12-LEAD ANALYSIS OPTION
  958. K010149WUJIN #3 FEMORAL NAIL
  959. K972431MERIDIAN DSP
  960. K882443ZINDRICK IM ROD INSTRUMENTS
  961. K161849Bright
  962. K781616OMNI STIK
  963. K183479Asthma Monitor AM3
  964. K223058EzRay Air 2 Wall (Model: VEX-S350W)
  965. K241621Da Vinci Monopolar and Bipolar Adapters (378896)
  966. K895900WILSON-COOK BILIARY AND GASTRIC ASPIRATION NEEDLE
  967. K152906Disposable High Pressure Injector Syringe
  968. K850324ELECATH OPEN TIP BIPOLAR PACING CATHETER
  969. K883023MODIFIED ULTRA-FRESH ODOR REDUCING COMPOUND
  970. K213728Serranator PTA Serration Balloon Catheter
  971. K024000METRICATH SYSTEM COMPRISED OF METRICATH 1000 CONSOLE & METRICATH BALLOON CATHETER
  972. K153119Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography…
  973. K201241Striate+™
  974. K073313MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP
  975. K080101AAP CANNULATED SCREW AND DARCO HEADED SCREW
  976. K870833CIBA CORNING/SHIMADZU MODEL 580 CLINI. CHEM. ANALY
  977. K022679RAPHAEL
  978. K083163OMNI 2 OXYGEN SYSTEM
  979. K772022SPECTROPHOTOMETER CARY 219
  980. K162550Medtronic Model 5392 External Pulse Generator (EPG)
  981. K873929'CATCH-IT' OR FECAL CONTAINMENT DEVICE
  982. K013876INFRARED EAR THERMOMETER, MODEL DX-707
  983. K131082INTERFORM INTERBODY CAGE SYSTEM
  984. K910553ROCHE APOLIPOPROTEIN STANDARD
  985. K220598AutoContour Model RADAC V2
  986. K024102DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
  987. K232529Disposable Double Lumen Endobronchial Tube
  988. K092907DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER…
  989. K891662PATIENT EXAMINATION GLOVES (LATEX)
  990. K851594SF BROTH
  991. K160560Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for…
  992. K001409GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
  993. K992399ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
  994. K781018DX TOOTHBRUSH
  995. K844963VITAPEP
  996. K980836GENIE CUP INTEGRATED SCREENING DEVICE
  997. K981726PERCUSSIVETECH HF, MODEL 2001
  998. K002242POLESTAR N-10
  999. K083005NANGEL
  1000. K943704LIPASE CALIBRATOR

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