Orca1

Data catalog

510(k) premarket notifications

About 178K records

More records

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

  1. K933178GDC 3509
  2. K250666Alegria Flash CTD Screen
  3. BK170157Automated Blood Cell Separators
  4. K914209MODEL 310GE-64: WHOLE VOLUME NECK COIL
  5. K952686BUCHALTER FAUSER FEMORAL COMPONENTS
  6. K253249TriALTIS™ Spine System
  7. K190918SwabTip Male Disinfectant Cap
  8. K110474PHILIPS INTELLIVUE TCG10
  9. K810690CURITY 100% SILICONE SAFETY INDICATOR
  10. K933290ORTHOLOC ADVANTIM
  11. K941929SUNGLASSES
  12. K032093PARIEFIX
  13. K093570POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR
  14. K231574Scenaria View 4.2
  15. K924871MODEL 880 INFUSION PUMP, MODIFICATION
  16. K141303ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
  17. K201393restor3d MTP Implant
  18. K811992ASSURE NATURAL FIT TAMPON
  19. K862838CYTOTECH HSV IGG ENZYME IMMUNOASSAY
  20. K830835STERILE 5 IN 1 CONNECTORS
  21. K945894MASK, GAS, ANESTHETIC
  22. K860987MINI-CHEM ANALYZER
  23. K954148SUTURE WASHER
  24. K823190BACKSTOP VALVE W/SIDE ARM
  25. K961744TK40 - TILTMASTER
  26. K250226Clarius Median Nerve AI
  27. K170315Acuson SC2000 Diagnostic Ultrasound System
  28. K760217SUCTION INSTRUMENT, MACBICK DIS. FRAZ.
  29. K903393AUTO FIRST-AID KIT FOR AMERICA
  30. K850735ENRICHED CULTURE MEDIUM
  31. K873239BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463
  32. K935348ODYSSEY CLINICAL AUDIOMETER
  33. K000694PECTOFIX DYNAMIC STERNAL FIXATION SYSTEM (DSF)
  34. K771805ACA SALICYLATE CALIBRATOR
  35. K092315SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
  36. K891966ALAMTEX PATIENT EXAMINATION GLOVES (LATEX)
  37. K162922GalaFORM 3D
  38. K883578S 21 INSTRUMENT STAND
  39. K851450FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM
  40. K003098ACCESS ULTRASENSITIVE HGH CALIBRATORS
  41. K984087SYSTEM U3 FOR AMPICILLIN
  42. K063233DELTACUT (APPARATUS AND CANNULA)
  43. K854622PROPHYLACTIC (CONDOM)
  44. K913670HAPTOGLOBIN IMMUNOLOGICAL TEST KIT
  45. K251764Oxygen Concentrator-P2-O5E
  46. K905555A-ZILICONE
  47. K95322032MM NICKEL PLATED DISC ELECTRODE
  48. K250542AC3™ Range™ Intra-Aortic Balloon Pump
  49. K932570MARK I HUMIDIFIER
  50. K902428INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS
  51. K192832Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i
  52. K051961WWMED, MODEL 401
  53. K930940LUKENS STAINLESS STEEL SURGICAL SUTURE
  54. K222453Self-adhesive Electrode
  55. K000263GO MEDICAL BALLOON INFUSION SYSTEM
  56. K000990OPUS 10 DENTAL DIODE LASER
  57. K861261OHMEDA POSI-PULSE SUCTION UNIT
  58. K834003MOTILITY INDOLE ORNITHINE-MEDIUM
  59. K142139SMR 40MM GLENOSPHERE
  60. K230478Acro Composites Interbody System
  61. K960955JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
  62. K033402PORTABLE SLEEP DATA RECORDER (PSDR)
  63. K021490REEVUE INDIRECT CALORIMETER, MODEL#8100
  64. K792499AMBU PAEDI ANAESTHESIA SYSTEM
  65. K151644Masimo Root Vital Signs Monitoring System and Accessories
  66. K822933SYVA ADVANCE EMIT AED VALPROIC ACID ASSA
  67. K855081PHOENIX MODELS 250/251 PULSE GENERATORS
  68. K864103CURITY ANESTHESIA FILTER
  69. K883629HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013
  70. K112099CONTOUR HEALER
  71. K791008ECA (SPECIAL) HEME BUFFER
  72. K950951NEOCAST C, V, S
  73. K972348HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
  74. K082964PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)
  75. K200281The Gecko Spinal System
  76. K171715HammerTube System
  77. K984552COOL-TIP RF SYSTEM
  78. K010453M2376A DEVICELINK SYSTEM
  79. K090856JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)
  80. K122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
  81. K802201SD-700 BLOOD PRESSURE MONITOR
  82. K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR
  83. K142360Everest Spinal System
  84. K942930CAPCARD
  85. K960170ELECTROENCEPHALOGRAPH (EEG)
  86. K091129QUATTRO LT
  87. K861060SITE PHACO DISPOSABLE CASSETTE
  88. K994046HARDYDISK CEFACLOR 30MCG
  89. K172270gammaCore-2
  90. K852479PULMONARY VEIN CLAMP
  91. K990442ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3
  92. K791190STETHOSCOPE WITH TEMPERATURE SENSOR
  93. K964608MRT-35A V9.0
  94. K924796LUNG DIFFUSION GAS MIXTURE
  95. K931220SPERMICIDAL LUBRICATED CONDOM
  96. K881943EMIT HVA CALIBRATOR KIT
  97. K140031SUCTION PUMP
  98. K884723(DATAGLOVE) HAND IMPAIRMENT EVALUATION SYSTEM
  99. K240663Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S)
  100. K01316214F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM…
  101. BK180220System, Test, Automated Blood Grouping and Antibody
  102. K790951SA/7860 FETAL HEART MONITOR (DOPPLER)
  103. K193377TopLock Anchor System
  104. K990978ALBUMIN BCG, MODEL AL 103-01
  105. K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
  106. K183623LifeSPARC Pump, LifeSPARC Controller
  107. K810919HEMOGLOBIN ELECTROPHORESIS CONTROL
  108. K881395GAUZE AND LAP SPONGES -STERILE & NON-STERILE
  109. K844163EZ 502
  110. K821237NEUROMATIC 2000
  111. K001088ULTRASIM CT SYSTEM
  112. K830439DENTA A-33
  113. K830687NORELCO ELECTRONIC ANALOG BLOOD PRESS
  114. K242922Extracorporeal Shock Wave Lithotripter (U200)
  115. K791570IL MODEL END TIDAL CO2 ANALYZER
  116. K111830FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY AUTOMATIC…
  117. K760957SURGICAL RECIPROCATING SAW
  118. K791983SPATULA'S #'S 7618,7248,7240,7242,5108
  119. K802434VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH
  120. K974494RENAMEL FLOWABLE COMPOSITE
  121. K110940ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL…
  122. K032724PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
  123. K072720ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
  124. K201438ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution…
  125. K830278FLORET GAUZE PACKING
  126. K861870DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER
  127. K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
  128. K021050KSEA NEUROENDOSCOPES AND ACCESSORIES
  129. K031400FABIUS TIRO ANESTHESIA SYSTEM
  130. K812690C-PEPTIDE CONTROL PACK
  131. K920517MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
  132. K860110GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET
  133. K990826INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM
  134. K131000V-PATCH SYSTEM
  135. K882773MCCOY'S 5A MEDIUM, CATA NO. 200-2026
  136. K063064MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML)
  137. K0934001ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2
  138. K153011iViewDose R1.0
  139. K022011V.A.C. ABDOMINAL DRESSING
  140. K202325EasyPoint Blood Collection Plus
  141. K923698BETAMIST 2
  142. K121176STGC
  143. K062510AESCULAP STERILCONTAINER SYSTEM
  144. K131148THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH
  145. K904155MEDILAS 4060N FIBERTOM(R) SURGICAL LASER
  146. K830527N.E.W. NEB
  147. K884543LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
  148. K083335MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
  149. K242804PAL Aspiration System
  150. K120361SYNAPSE 3D BASE TOOLS
  151. K043116ICSI-100
  152. K874100AML CALCAR FEMORAL PROSTHESIS
  153. K841433CORNING LACTATE DEHYDROPHORETIC ASSAY
  154. K810431NARCO TLECARE MINIATURE PRESSURE DOME
  155. K861413BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
  156. K923056NEUROSIGN MODEL 100
  157. K151465AeroDR SYSTEM 2
  158. K823538POUR BOTTLE DECANTER #2010
  159. K791147ARCO PROGAMMABLE PACEMAKER SYSTEM
  160. K240351FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)
  161. K872951AMERICAN BRAIN RETRACTOR COVER
  162. K243582da Vinci SP Advanced Access Port Kit (432701)
  163. K962237THUMPER CARDIOPULMONARY RESUSCITATOR
  164. K212643POWERSEAL Curved Jaw Sealer and Divider, Double Action
  165. K072447PENTABORN
  166. K254028Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV…
  167. K253502Critical Care Suite with Enteric Tube Positioning AI Algorithm
  168. K234070Stelo Glucose Biosensor System
  169. K221860PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume)…
  170. K925880KODAK AMERLITE CK-MB CONTROL SERA LAN.4413
  171. K971458ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
  172. K820967BIOPSY FORCEPS W/ALLIGATOR TYPE CUPS
  173. K900189CURAPULS 403 DIATHERMY UNIT
  174. K233264Anthogyr INTEGRAL Guided Surgery Cassettes
  175. K844674APPLIED GAUZE SPONGE 2X2X8 PLY
  176. K771271SCALP VEIN SET
  177. K961000CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
  178. K143079Endovascular Stent Planning Software
  179. K935477AS/3(TM) ANESTHESIA MONITOR SYST INTERFACE BOARD
  180. K772084LAS-R HUMAN C3 PROACTIVATOR TEST
  181. K972011OPUS ETHANOL
  182. K220231GyroStim
  183. K211185IPL Home Use Hair Removal Device
  184. K222113Abiomed 14Fr Low Profile Introducer Set
  185. K895115FRANK INHALER THERMAL S
  186. K924030SCRIBE
  187. K031877EMBRACE WET-BOND RESTORATIVE MATERIAL
  188. K920731X-RAY TUBE ASSEMBLY CIRCLEX1.2UG
  189. K131223CARESCAPE MONITOR B650
  190. K092604LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL…
  191. K191710FlowTriever Retrieval/Aspiration System
  192. K953920REVERT SUNGLASSES & POLAR SUNGLASSES
  193. K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer…
  194. K993754HSV-1 ELISA IGG, MODEL EL0910G
  195. K120681ADVIA CHEMISTRY GLUH_3 REAGENTS
  196. K943880RIA LATEX CONDOM
  197. K884940RELLPLATE C KIT, RELLPLATE C BULK PLATES
  198. K932692INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
  199. K832235DISPOSABLE VITRECTOMY HANDPIECE
  200. K951737ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
  201. K895964DCL SYPHILIS-M CATALOG NO. 600-80
  202. K961564EG-2940, VIDEO GASTROSCOPE
  203. K792433TEMPORARY BURN SHEET WITH PERFORATED
  204. K172737MESIRE - Balloon Sinus Dilatation System
  205. K954050RESECTOSCOPES
  206. K862379CORNEAL MODELING SYSTEM
  207. K193295Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor
  208. K964781IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT
  209. K013081MEDSTAR 150
  210. K121356MICRO/MINI N-PK(H) BONE ANCHOR
  211. K865079ASPIRATING NEEDLE, CATALOG CODE #12006
  212. K093352HG III FIXTURE SYSTEM
  213. K950656PED ALERT
  214. K940128CAT-400UL PENILE PLETHYSMOGRAPH
  215. K100424DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
  216. K953737VL7600 REM PATIENT RETURN ELECTRODE
  217. K893212THERMALAP
  218. K894995LATEX PATIENT EXAMINATION GLOVES
  219. K153102QuadraSphere Microspheres
  220. K843926PRESTILIX 1690
  221. K994138FIRST CHECK HOME DRUG TEST PANEL 3
  222. K183535Fully Automatic Electronic Blood Pressure Monitor
  223. K111460OPTO HYALUS GREEN LASER
  224. K243968Revolve Surgical System
  225. K261041ClearSafe Closed System
  226. K150293EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear…
  227. K913004BACTIDROP(TM) SPOT INDOLE
  228. K953441RIZA-RIBE NEEDLE
  229. K881738AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID
  230. K881742BIOTROL ALKALINE PHOSPHATASE
  231. K772282HODGE TUBE
  232. K843136BRIMFIELD CANNULATED GRASPING HOOKS
  233. K100074POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW)
  234. K792704HISTOPLASMA CAPSULATUM, ANTIGEN YEAST
  235. K970508ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
  236. K182622GU60A, GU60A-65
  237. K991898ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
  238. K961434VITA ZETA CROWN AND BRIDGE ACRYLIC VENEERING SYSTEM
  239. K004021F1 DIODE LASER SYSTEM
  240. K972756MODIFICATION OF EST CULTURE SYSTEM II - MYCO
  241. K905511CODMAN NEUROLASE LASER SYSTEM/MODIFICATION
  242. K801916ORNITH-ASE TUBES
  243. K220760Pre-Formed Penile Silicone Block
  244. K982900PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW
  245. K171244Physiotrace
  246. K042069INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
  247. K873214APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300
  248. K914125FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403
  249. K103119BILLY BOY MALE LATEX CONDOM
  250. K971814IMPROVEMENTS TO THE MEHL RUBY LASER
  251. K022327NOVUS SPECTRA
  252. K952408ATI DISPOSABLE TEST PACK FOR STEAM STERILIZATION
  253. K974743MANAN
  254. K260506Ventana® P/T Lumbar Interbody System
  255. K993377MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
  256. K851198MEDIPART LUNG AEROSOL KIT MP-1012A
  257. K821627THE ARTIFICIAL URINARY SPHINCTER
  258. K181750SITZMARKS
  259. K871896TINA-QUANT [A] TRANSFERRIN
  260. K922700DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH.
  261. K820087CODMAN * REUSABLE PERFORATOR
  262. K915557RICH-MAR MODEL 510 ULTRASOUND
  263. K854852WELLCOGEN BACTERIAL ANTIGEN KIT
  264. K193387Arm Electronic Sphygmomanometer
  265. K922242910T MONTORIZED INSTRUMENT TABLE
  266. K982051KELOCATE SHEETING
  267. K212198Tyvek(R) Roll with CI for STERLINKTM Sterilizer
  268. K951049SPECULUM, ENT (S3)
  269. K150631St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire…
  270. K260228POYA 3.5mm Medial Proximal Tibia System
  271. K220466ibiomedi Electronic Stethoscope ES-2020
  272. K780242SPECTROPHOTOMETER, FLUORESCENCE M.650-10
  273. K901683IMPROVED BAKER TWIN-CUFF SUMP TUBE
  274. K952242TRANSFEER SPIKE II
  275. K133981AVACEN 100
  276. K830195NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
  277. K790165OXYGEN MASK-HIGH CONCENTRATION
  278. K972502SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
  279. K190756IODOFLEX
  280. K183066The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with…
  281. K842856LANDERS-FOULKS TEMP. KERATOPROSTHESIS
  282. K172582EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™…
  283. K092749MAS AND MINI-TROL PTH CONTROL
  284. K935496NANOSEP N10
  285. K832874ISOVIS WOUND PROTECTOR
  286. K201131firefly T-2
  287. K191618SleepTight Mouthpiece STZ
  288. K090740MODIFICATION TO: TSRH SPINAL SYSTEM
  289. K180765Televere Podiatry X-Ray System HF
  290. K963079CANON TX-10 TONOMETER
  291. K012336MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
  292. K010875HYCARE LATEX EXAMINATION GLOVE, POWDERED
  293. K030776MEGA BITE REGISTRATION - DENTAL BITE REGISTRATION MATERIAL
  294. K982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1
  295. K895142ENTERAL PUMP SET WITH ENTERAL SPIKE
  296. K843665PARAINFLUENZA 1
  297. K202992BriefCase, RIB Fractures Triage (RibFx)
  298. K093127TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
  299. K221569Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
  300. K862827FCW TUBE STAND
  301. K853660MICRO SURGICAL DRILL SYSTEM
  302. K953760CORDIS WIZDOM STEERABLE GUIDEWIRE
  303. K130678BIOMARC GOLD FIDUCIAL MARKER
  304. K844402SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
  305. K934657BRAINLAB LINAC HARDWARE
  306. K911472BIO-SENSOR 01 EKG ELECTRODE
  307. K972662CRYOGEN CRYOSURGICAL SYSTEM
  308. K852841RAPID DIRECT STREP A LATEX AGGLUTINATION TEST
  309. K845033FOREMOST DENTIN ADHESIVE
  310. K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath…
  311. K092328MED-SEG, MODEL BTMS 1000
  312. K254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
  313. K872729INFUSION STAND
  314. K821247ACCUDEX REAGENT STRIPS
  315. K011492IN TEN-S
  316. K060306ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY
  317. K083665VERIFY SCBI 275F 3-10
  318. K885262POLYHESIVE MONITORING AND DIAGNOSTIC ELECTRODES
  319. K203667EzRay M (Model: VMX-P300)
  320. K800164413A NEONATAL MONITOR
  321. K980237GYNEX ENDOSPECULUM
  322. K860654M.C.R. KNEE PROSTHESIS (SERIES 3000)
  323. K850096LASER-GLOBIN
  324. K001640BIOSOFT RESIN
  325. K902593RAICHEM(TM) SPIA(TM) CRP REAGENT
  326. K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…
  327. K954909PROFIX POSTERIOR-STABILIZED KNEE SYSTEM
  328. K781647BACK TRAC
  329. K904236ENDOSSEOUS IMPLANTS
  330. K193582SterilContainer S2 System
  331. K093297EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
  332. K011227REGAL MOTOTRIZED 3 WHEELED VEHICLE
  333. K973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODE
  334. BK080073SOFTWARE, BLOOD VIRUS APPLICATION
  335. K253615Invictus Bands System
  336. K904576HEARING AID, UNITRON MODEL UM60-UH
  337. K000961AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
  338. K851710586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC
  339. K820923DULBECCO'S PBS POWDER
  340. K160412GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
  341. K062957FASTPACK TOTAL PSA METHOD VERIFICATION KIT
  342. K010089REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS-RP (PROPOSED)
  343. K901307PASSAGE AIRWAY SPLINT
  344. K962236SCARF THREAD-HEAD SCREW
  345. K883822FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309
  346. K212708Halo One Thin-Walled Guiding Sheath
  347. K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…
  348. K864493REVISED RESISTANT 5 MIC PANEL
  349. K911869IVT GUIDING CATHETER
  350. K924043AUTO-PEEP
  351. K151744Passeo-18 Peripheral Dilation Catheter
  352. K071250CA, MODEL: CAM
  353. K833579MODIF. OF EMIT URINE AMPHETAMINE
  354. K040037MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
  355. K800939COMPUTRIM 900
  356. K991011ORASCOPE
  357. K812551BEAUCOR
  358. K925978MPC-80 TRANSDUCER
  359. K230112CAC Software
  360. K171051HORIZON Therapy System
  361. K851876PREFER INCONTINENCE AID
  362. K871175JUMBO DIGITAL GAMMACAMERA, GCA-901A
  363. K812125LAPIN CLEAR CUT II
  364. K210302Disposable Medical mask
  365. K961867PEEP VALVE
  366. K021149AURORA DS
  367. K940213UNIVERSAL CUSHIONED METAL EYE SHIELD
  368. K921451EVACUATOR, GASTRO-UROLOGY
  369. K221337Materialise TKA Guide System
  370. K761198MODEL 3044 3-CHANNEL STRESS TEST SYSTEM
  371. K260849ICON 35; ICON 45; ICON 60; ICON 30FAF
  372. K122729ABL90 FLEX
  373. K891261INTRAOPERATIVE RADIATION THERAPY DEVICES
  374. K243799Fetal Pillow
  375. K241616ALLONUS Tech Prosthetics
  376. K231678Overjet Periapical Radiolucency Assist
  377. K120866DA01 BLOOD GLUCOSE MONITORING SYSTEM
  378. K061787MAXFORCE TTS SINGLE-USE BALLOON DILATOR
  379. K792136HYPO-ALLERGENIC PLASTIC TAPE
  380. K873626FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM
  381. K932646ROLLENS POST-MYDRIATIC SUNGLASS
  382. K93039616 X 125 MM TEST TUBE, CATALOG #01-291
  383. K983058CERALAS D LASER SYSTEM, MODEL # CERALAS D15
  384. K132597BLACK COLOURED CONDOM
  385. K954743DERMAGRAN WOUND DRESSING CLEANER W/ZINC
  386. K261488OBSIDIO Conformable Embolic
  387. K050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
  388. K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…
  389. K863995KEYNOTE
  390. K041710VERSAWAVE DENTAL ER:YAG LASER SYSTEM
  391. K903765QUIDEL CHLAMYDIA POSITIVE CONTROL
  392. K142100AIXPLORER
  393. K002718ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER…
  394. K181578DemeTECH PTFE Nonabsorbable Surgical Suture
  395. K892398BIPOLAR HIP SYSTEM
  396. K992283ARTISAN ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
  397. K153674Sorbact Foam Gentle Border, Sorbact Superabsorbent
  398. K000128HARDYDISK, CEFAZOLIN, 30MCG
  399. K961080MEDIAL MALAR IMPLANT
  400. K884937BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING
  401. K822750MEDI-TRACE 5' OFFSET ELECTRODE
  402. K040324WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH
  403. K961948SAS SALMONELLA O FACTOR 20 ANTISERUM
  404. K060235ENDO-EASE ENDOSCOPIC OVERTUBE
  405. K202507EEA Circular Stapler with Tri-Staple Technology
  406. K941213SONGER CABLE SYSTEM
  407. K203817Tyber Medical Anatomical Plating System
  408. K072776THE CROSSER SYSTEM
  409. K924432MEDISON 1500
  410. K140501XENMATRIX SURGICAL GRAFT
  411. K946094CADWELL EASY AMBULATORY EEG
  412. K012600CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
  413. K093185OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
  414. K810285BARNES-HIND ROSE BENGAL OPHTHALMIC STR.
  415. K002001BREEZE SLEEPGEAR WITH DREAMSEAL
  416. K944984EMSEE LABS MODEL S
  417. K903039A-1101 CAST ABUTMENT
  418. K933829PULSE ELECTRIC TOOTHBRUSH
  419. K212910Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece
  420. K820833AUDICRAFT VIP HEARING AID
  421. K003030LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
  422. K120433CLEAR + BRILLIANT LASER SYSTEM
  423. K922754TANDEM-E IGE II CALIBRATION VERIFICATION SET
  424. K200503ATL Anchors
  425. K944607MODEL 5135 AUTO LP/FLASH
  426. K133852APOLLO BALLOON DILATATION CATHETER
  427. K073181NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL
  428. K182153Ultrasound System SONIMAGE HS1
  429. K930770MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
  430. K903151INTERVERTEBRAL DISC RONGEUR
  431. K022789VIATRONIX V3D EXPLORER
  432. K844082QUEST BETA HCG ENZYME IMMUNOASSAY KIT
  433. K862610ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
  434. K882184HR-1000 W/SUFFIXES (B,C OR D)
  435. K120384PROTECTOR, INJECTOR, CONNECTOR
  436. K925869SHEATHES, STERILE SHEATHES
  437. K020110MODIFICATION TO TRELEX MESH SURGICAL MESH
  438. K123484SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT…
  439. K190008Carescape One
  440. K203006R2 Dermabrasion Tip (for Dermal Cooling System)
  441. K203186DYNATAPE Suture
  442. K072314DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR
  443. K000334IMPACT MODULAR TOTAL HIP SYSTEM
  444. K960109QUANTITATIVE SENTINEL SYSTEM
  445. K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…
  446. K930135SILICONE RECTAL BALLOON
  447. K844662KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI
  448. K820980BIOPSY FORCEPS W/OVAL CUP & NEEDLE
  449. K812707STERILE DISSECTOR SPONGES-X-RAY DETECT
  450. K852041DEKNATEL THORACIC CATHETER
  451. K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER
  452. K920877THE KEYSTONE SYSTEM
  453. K083248FULLY AUTOMATED ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7902
  454. K061013PLAYTEX EMBRACE PETITE BREAST PUMP
  455. K243567Tyto Insights for Rhonchi Detection
  456. K936214CS-PLUS STEM
  457. K830902OCUCARE PACK
  458. K850647HEATED RESPIRATORY HUMIFIFIER MR440
  459. K020672ELECSYS ANTI-TG TEST SYSTEM
  460. K202092ABC Dental Implant System
  461. K121511MACLIN POWER INTRAVASCULAR ADMINISTRATION SET
  462. K021145ACCOMMODATOR WHEELCHAIR, MODEL #2000X
  463. K172713Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT…
  464. K932827ALPHA-DENT CORE BUILDUP PASTE
  465. K183632Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
  466. K991607VANTAGE 2.5
  467. K003857STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
  468. K103488CONCORDE BULLET CAGE SYSTEM
  469. K203275Recon Support Catheter
  470. K983821PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
  471. K081308FUJIFILM FCR VIEW, MODEL CR-VW674
  472. K972053PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
  473. K101043ECT DIGITAL THERMOMETER
  474. K964066DUAL SLIM PORT IMPLANTED PORT (0654970/0654940)
  475. K211414KHEIRON Spinal Fixation System
  476. K254297Tempus ECG-MR
  477. K060785POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES W/ALOE VERA, GREEN COLOR
  478. K972973PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
  479. K011996TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
  480. K171316O2Vent W
  481. K133012SENTIERO
  482. K910564VERSACATH(TM0 MAINLINE(TM) WITH INTRODUCTION TRAY
  483. K130709VISI MOBILE MONITORING SYSTEM
  484. K910830INVALIFT
  485. K110152SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
  486. K234059Forma Medical Optimal Plating System
  487. K960240RUSCH OPTOSAFE
  488. K041819GOODKNIGHT 425, MODELM-114500-00
  489. K781360MODEL 80100A, PATIENT DATA MEMORY
  490. K183708Poly Clear
  491. K110569AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
  492. K143443VEGA Knee System, Columbus Total Knee System
  493. K063641PC-60, NON-INVASIVEPULSE OXIMETER
  494. K920618AUTOTRANSFUSION SUCTION SET
  495. K925433THE STACHROM HEPARIN ASSAY KIT
  496. K994021CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
  497. K954051SIME POWDERFREE PLUS
  498. K063459CRANEX NOVUS
  499. K190354BRAUN Silk.expert Pro 5
  500. K952957THE TULIP INSULATED GRASPERS
  501. K091553BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE
  502. K020022DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
  503. K810649INVALID CUSHION
  504. K941973GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
  505. K970785SIMS HYPERINFLATION BAG SYSTEM
  506. K253726uAngio AVIVA CX
  507. K904440LOCAL PLEXUS BLOCK ANESTHESIA CATHETER KITS
  508. K151423APEX Compounding System Transfer Set
  509. K112311ALP 501 RB PUMP SYSTEM
  510. K904394INFLATION/DEFLATION DEVICE
  511. K022979LAPARETTE, MODEL LAP J L S H N
  512. K092516POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
  513. K892263MERIFLUOR(TM) -TRICHOMONAS
  514. K943281POLYETHYLENE VENT TUBES
  515. K93036525CM2, 75CM2, 150CM2 FLASK, CATALOG #03-241
  516. K081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHT
  517. K934411MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
  518. K190644Guide Sheath
  519. K040812DETECT SURGICAL PACING AND MAPPING TOOL
  520. K020571STOCKERT CENTRIFUGAL PUMP CONSOLE
  521. K162868Exam Vue PACS
  522. K771368PORTABLE INFANT VENTILATOR
  523. K931356SAFE AIR VARI-SPOT HANDPIECE TELESCOPE AND ADAPTOR
  524. K871904TOTAL LUNG EXERCISER (TLE)
  525. K873213HICKMAN PLASTIC SUBCUTANEOUS PORT
  526. K160208NILE Alternative Fixation Spinal System
  527. K090700IMMUNOCARD STAT CAMPY, MODEL 751530
  528. K902199COULTER DIRECT BILIRUBIN
  529. K85180069-100 TO 69-114 VARIOUS CUTICLE SCISSORS
  530. K083757BPZ02 MULTIPURPOSE SOLUTION
  531. K963220TEMPRA COLD PACK, REORDER NO. TC150
  532. K012128PROTECTIV ACUVANCE IV CATHETER SYSTEM
  533. K111232GAP ENDO-EXO MEDULLARY SYSTEM
  534. K963461SAFETY PONCHO/SHOULDER STRAP PONCHO
  535. K250517Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD…
  536. K023102ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM
  537. K121347PRESSON ELECTRODE
  538. K980698ASTRA TECH IMPLANTS - DENTAL SYSTEM
  539. K780171ELBOW PROTECTOR
  540. K832788INFUSE-A-PORT
  541. K932675GXP DENTAL X-RAY PROCESSOR
  542. K791468RESUSCI-BAG-VALVE
  543. K820989MEDTRONIC #6993
  544. K013789EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
  545. K012983ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
  546. K854906PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
  547. K844986ROCHE REAGENTS REAGENT FOR URIC ACID
  548. K864455THE EXPERIMENTAL
  549. K831941LEAP RHEUMATOID FACTOR TEST KIT
  550. K980671COLOSCREEN-ES
  551. K081514TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND…
  552. K850994SPECTRA 1 FILTER PHOTOMETER
  553. K943719VISISTAT STAPLER
  554. K101673URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10
  555. K210913V12 PRO
  556. K101224SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
  557. K820778RESPIRATION MONITOR 1000
  558. K926312INFRARED EYE MOVEMENT MONITOR
  559. K870860CHEMPRO 1000(TM)
  560. K151578Carbamazepine Gen 4
  561. K050327E-POLY (VITAMIN E) ACETABULAR LINERS
  562. K152493POGO Automatic Blood Glucose Monitoring System
  563. BK150308Blood Establishment Computer Software and Accessories
  564. K172343Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
  565. K152178StimQ Peripheral Nerve Stimulator (PNS) System
  566. K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…
  567. K142969ANI Monitor
  568. K831960TEST FOR HUMAN ALPHA ONE ACID GLYCO-
  569. K893264LATEX EXAMINATION GLOVES
  570. K963805PRODIGY AC
  571. K130115DISCOVERY MR750W 3.0T
  572. K803071PLA-MATE
  573. K181343HeartSee Cardiac P.E.T. Processing Software
  574. K872604HAND/FOOT 624-208
  575. K033948MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)
  576. K810686SR-IVOLEN
  577. K840211FIBRI-PREST AUTOMATE HA34
  578. K132199DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL…
  579. K770098HOOK, IRIS, HERSHMAN
  580. K922349DOWD(TM) II
  581. K13113721.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
  582. K933259SCD(R) CONTROLLER
  583. K852011NYLAMID MESH PAD FULL & HALF
  584. K931293SSH-140A FETAL DOPPLER SYSTEM
  585. K900514JYROCHAIR POWER WHEELCHAIR
  586. K000492MDA D-DIMER
  587. K842431ALLIED ASSOC. THERAP. EXERCISE EQUIP-
  588. K920996BARRIER SURGICAL GOWN WITH SYMETRY FABRIC
  589. K860739CHICK SURIGICAL LIGHT
  590. K012649RAICHEM BUN RATE REAGENT
  591. K200183CS 9600
  592. K930089SMS BALANCE PERFORMANCE MONITOR
  593. K142392Zavation Posterior LEIF
  594. K913312HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED
  595. K863401RECOVER
  596. K853619APL TRIPLE SUGAR IRON AGAR
  597. K251970Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
  598. K770480IN VITRO T-3 UPTAKE TEST
  599. K802272COMPUTER ECG TERMINAL
  600. K822029MONOJET 520 20CC SYRINGES W/NEEDLES
  601. K011899PF 5050 PRESSURE UNIT, MODEL PF 5050
  602. K130807POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
  603. K900991SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET
  604. K043222VISCUCAM C DIGITAL CAMERA
  605. K032551MASIMO LNOP-TF-I RESUABLE TRANSFLECTANCE SENSOR
  606. K964630GLUCOMETER ELITE BLOOD GLUCOSE METER
  607. K052316POWERHEART ECD
  608. K251952Virasight
  609. K852938TUF TRACK MODEL TT83 CUBICLE TRACK & IV83 INTR TRK
  610. K861531DISPOSABLE SURGICAL DRAPES AND ACCESSORIES
  611. K201039HepaFat-AI
  612. K061776ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE
  613. K895959BREVET FLOSS PICK (COLD STERILIZATION FLUIDS)
  614. K832064VENOUS CATHETER
  615. K962394IMPLANT INTEGRATION SYSTEMS DRILLS AND TAPS
  616. K0122001.5T INFINITY TWINSPEED MR SYSTEM
  617. K080292EPICOR ABLATION SYSTEM
  618. K061239EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
  619. K090431DEXIS SOFTWARE
  620. K914922UNISURGE TISSUE COLLECTION SYSTEM FOR ENDOS SURG
  621. K970299JUPITER PTA CATHETERS (VARIOUS)
  622. K183089Air Next
  623. K161164CareEvent inclusive of the CareEvent Mobile Application accessory
  624. K974593SEMKIN INSULATED BIPOLAR FORCEP
  625. K092420KRD1 PEDICLE SCREW SYSTEM
  626. K102573PROVU (TM) DENTAL X-RAY SYSTEM
  627. K791862HEART RATE COMPUTER
  628. BK120051Blood Establishment Computer Software and Accessories
  629. K203756Disposable Surgical Mask
  630. K863150BOWEN CANNULA
  631. K233893AlphaVent Knotless SP PEEK Anchor
  632. K852548ATL 225 MW TRAIL LENS SET
  633. K072969DSS
  634. K911820GED (GRADUATED ELECTRONIC DECELERATOR
  635. K043168BISCOVER LV
  636. K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
  637. K201876Soteria Bed Barrier
  638. K890829UNIFAST LC
  639. BK070057Container, Empty, For the Collection '& Processing of Blood/Blood Components
  640. K853520LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD
  641. K791433KOTEX LIGHTDAYS DEODORANT PATILINERS
  642. K053216HEARID WIDEBAND MIDDLE EAR POWER ANALYZER
  643. K782157IRMA TEST, NORDICLAB FERRITIN
  644. K212789Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
  645. K831706SATO FAMILY FIRST AID KIT
  646. K833627CIRCULATOR MINIBOOT
  647. K840618LIQUI-URA CHEMISTRY URINE CONTROLS
  648. K955611KMANZ II
  649. K223022SC HONKYTONK PTCA Balloon Dilatation Catheter
  650. K131234LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
  651. K033219BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
  652. K823078SPUNGUARD FACE MASK
  653. K080331SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
  654. K173136Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
  655. K812610SIEMENS-ELEMA PULSE GENERATOR 668 B
  656. K190221IOB Warming Blankets
  657. K170870Site~Rite Halcyon Diagnostic Ultrasound System
  658. K961690CARDIOARC SERIES: POSITIONER C-ARM MODELS NO. 6896.001 AND 6896.105
  659. K093650BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
  660. K904585POST MYDRIATIC SPECTACLES
  661. K982672COLLEAGUE PUMP SYRINGE ADAPTER SET
  662. K140662FLEX ENDOSCOPIC INSTRUMENTS
  663. K092456MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C
  664. K894065OPUS MODEL 4001
  665. K881944EMIT HVA CONTROL KIT
  666. K851330PROLACTIN SYSTEM BY RIA
  667. K133652GSP NEONATAL TOTAL GALACTOSE KIT
  668. K111219GMD UNIVERSAL URINARY INCONTINENCE SLING
  669. K981198MEDTRONIC ZUMA GUIDING CATHETER
  670. K173701Implant-One System
  671. K943768HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
  672. K151780CAAS Workstation
  673. K013771MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND…
  674. K110747TEMPFLEX
  675. K041419LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
  676. K912455DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL
  677. K941047WESTERN TRADING CO
  678. K832762MILLER/NADLER GLARE TESTER
  679. K926344HYDROPHILIC COATED GUIDEWIRE
  680. K902057PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
  681. K883586TECHNICON RA-100 SYSTEM POTASSIUM
  682. K992775OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500, QDR4000, QDR1000…
  683. K911777ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED
  684. K964617GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
  685. K060484ERBE VIO ESU, MODEL VIO 300 D
  686. K980071SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
  687. K974432ULTRAGUIDE 1000
  688. K925590MULTI-TRAUMA DRESSING
  689. K940694XEROFORM PETROLATUM DRESSING
  690. K130069INNOVA EPVISION 2.0, INNOVA EPVISION 2.0
  691. K031468TEMPORARY TITANIUM ANEURYSM CLIP
  692. K120147ACE STAPLER AND CARTRIDGE
  693. K85177519-790 TO 19-1042 DRESSING/SPONGE FORCEPS
  694. K882446ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
  695. K023048MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT
  696. K052304SUPER PORCELAIN EX-3 PRESS
  697. K243487CryoFreeze Wart and Skin Tag Remover
  698. K001373LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363
  699. K130088PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
  700. K072229MONOSWIFT
  701. K874873COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
  702. K041590AUTODETECT SYRINGE
  703. K010421WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML…
  704. K870421TDMAC-HEPARIN COATED RMI
  705. K860160OPERATING ROOM TRAY
  706. K012953GIOTTO IMAGE
  707. K980367AEROSET SYSTEM
  708. K020164E-SCAN XQ
  709. K810278EYEGLASS FRAMES
  710. K030937STIMUCATH CONTINUOUS NERVE BLOCK SET, MODELS AB-02030, AB-02060, AB-02090, AB-02030-PK…
  711. K180263EcoFit Vit E Acetabular System
  712. K850209QUICK-LYTE
  713. K844632INFANT LIMB ELECTRODE
  714. K032996ELEKTA SYNERGY SYSTEM
  715. K090953TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
  716. K934342GLASER RT450 HEARING AID TEST AND ANALYSIS SYSTEM
  717. K970656HYDROFLEX
  718. K252153FFX Facet Fixation System
  719. K163379KneeAlign 2 System
  720. K772073RADIAL IMMUNODIFFUSION KIT-COMP. 3
  721. K823509P-S MED. LUMBO PERITONEAL & VENTRICULO-
  722. K024047ERBE VIO APC WITH ACCESSORIES
  723. K211880Minuteman G5 MIS Fusion Plate
  724. K071808MIRAGE MICRO
  725. K954506EMOX
  726. K904999WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE
  727. K161016Z-Clamp ISP System
  728. K143321ITST Intertrochanteric/Subtrochanteric Fixation System
  729. K760351CATHETER, ARGYLE THORACIC
  730. K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3
  731. K864029AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID
  732. K904998THE BODY COOLER SYSTEM
  733. K121256ALCO-SCREEN 02
  734. K020408SYSTEM 2000 CONTROLLER, SYSTEM 5000 CONTROLLER, FOOTSWITCH, POWER CORD, AND VISAGE WANDSFF
  735. K921750CVIS INSIGHT III SYSTEM
  736. K883266FDL ELISA FOR CHLAMYDIA
  737. K9748563.25MM SIMPLER THREADED DENTAL IMPLANT
  738. K120184POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLORED, BLACK COLORED AND WHITE COLORED
  739. K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
  740. K111480MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
  741. K080418REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET…
  742. K222780LILY Extension Tube and Needleless Connector
  743. K940489SIMON NITINOL FILTER
  744. K792711HISTOPLASMA CAPSULATUM, ANTISERUM
  745. K122365ULTRACHECK CURVE BLOOD PRESSURE CUFFS
  746. K902732KODAK X-OMAT 460 RA PROCESSOR
  747. K834448URINARY DRAINAGE CONTAINER
  748. K945069FLEXILOG 2000
  749. K071550PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
  750. K192098EzMobile
  751. K913490PHOENIX BURR HOLE BUTTON, BURR 1
  752. K101644QUANTA FLASH H-TTG IGG
  753. K870538MODEL 192 PRINTER
  754. K013761MEDLINE EXCEL RECLINCER WHEELCHAIR
  755. K191611Diode Laser Therapy Systems
  756. K760010COLORIMETRIC DETERMINATION (SGOT/SGPT)
  757. K110567C.T.M. MOBILITY SCOOTER HS515(3W)
  758. K082681VACORA VACUUM ASSISTED BIOPSY SYSTEM
  759. K862266MAPLE ALLERGEN DISC
  760. K875177J&J SCALP VEIN INFUSION SETS
  761. K051605SBI K-WIRES
  762. K202151Smart SPACE Shoulder System
  763. K851029NEW VITAJET
  764. K802786POROPLAST-EYE DRESSING
  765. K941401MILL ROSE ERCP CANNULAS
  766. K200742JUSHA-CP610 LCD Monitor
  767. K895663SITE 810E PHOTOCOAGULATOR AND ACCESSORIES
  768. K042890TRIAGE D-DIMER TEST, MODEL 98100
  769. K861913SLENDER REGULAR TAMPAX TAMPONS
  770. K861895UNI-TENS
  771. K111945IMPAX NEXT GENERATION
  772. K812372GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF
  773. K760404BI-CENTRIC SYSTEM
  774. K903910LUBRICATING JELLY
  775. K060546BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
  776. K050926TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060
  777. K082830INFX-8000H, INFINIX-I
  778. K242292uAI Easy Triage ICH
  779. K894235EB VCA STAT M TEST KIT
  780. K771512COUNTER MODEL S PLUS BLOOD CELL COUNTER
  781. K971039HEMAGEN ANTI CARDIOLIPIN SCREEN
  782. K993242CASTLE SURGICAL LIGHT, MODEL 3000
  783. K972037PROWLER
  784. K831487ELECTRONEURAL STIMULATOR 12
  785. K894161ASC-950 ECG AMPLIFIER
  786. K894477INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM
  787. K781653NEPHELRATE ANTISERUMS C3C
  788. K885019BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
  789. K884418PREMIER DIE-TRAK ARTICULATOR
  790. BK200517Blood Establishment Computer Software and Accessories
  791. K220886Upper Arm Type Blood Pressure Monitor
  792. K103556IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON…
  793. K872255TAMPAX DEODORANT TAMPON, SUPER PLUS
  794. K853136MODEL 1100 APC(ANGIOPLASTY PRESSURE CONTROLLER)
  795. K223847CREED™ Cannulated Screws
  796. BK130068Platelet And Plasma Separator For Bone Graft Handling
  797. K130995NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY
  798. K923565OLYMPUS IRON REAGENT
  799. K082391PRIMAEVA MEDICAL RENESIS SYSTEM
  800. K131410CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM)…
  801. K840651MOLE-MARKER
  802. K911955OLYMPIC WARMETTE
  803. K213142Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors…
  804. K883666QUIDEL ALLERGY SCREEN
  805. K211305ANNE One
  806. K141049IFUSE IMPLANT SYSTEM
  807. K180363Clear-Tip EUS-FNA
  808. K172335Bleep DreamPort
  809. K982057BC 900 SLIT LAMP
  810. K853095BOEHRINGER LABORATORIES SUCTION INTERMITTOR
  811. K042449DOLPHIN INFLATION DEVICE
  812. K860210ELEFIX ELECTRODE CREAM
  813. K073323SA-3000P
  814. K993781SIMPLEX CONDOMS, LATEX CONDOMS-SILICON LUBRICATED
  815. K781549TOXELISA TEST KIT
  816. K200854DePuy PINNACLE Dual Mobility Liner
  817. K961022TANGENT VI TABLE
  818. K123008RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM…
  819. K780303AUTO ISO-FILTER COLLECTION TUBE CAP
  820. K230386SpassageQ
  821. K181789VeriSuite
  822. K851957CHIBA NEEDLE
  823. K874192MULTIPURPOSE TRANSDUCER RANGE
  824. K781231OXYGEN SUPPLY TUBE, DISP., PLASTIC
  825. K895217CORTICAL SCREW
  826. K072866ISSYS LP SPINAL FIXATION SYSTEM
  827. K133046OMNIPORE CUSTOMIZED SURGICAL IMPLANTS
  828. K203339NEOLab Clear Aligners
  829. K211507Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
  830. K254036Novii+ Wireless Patch System
  831. K080302CAYMAN BUTTRESS PLATE SYSTEM
  832. K790776DADE LOW IONIC STRENGTH SOLUITION (LISS)
  833. K893915EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420
  834. K955650OLYMPUS SD SERIES SNARES
  835. K230834CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
  836. K180453Bio-Medicus Adult Cannulae and Introducer
  837. K050322MICROTEK EQUIPMENT DRAPES
  838. K890830DENTURE RESIN
  839. K972414FRESHCELLS
  840. K861416CANON AUTO ACUITOMETER CV-10
  841. K911079AMB-ALERT
  842. K113212DENTAL LASER THERAPY SYSTEM
  843. K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
  844. K072625TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
  845. K013140RHODIA HYDROPHILIC DENTAL IMPRESSION MATERIAL
  846. K862623I81 INITIALES
  847. K864147AQUAVALVE
  848. K003441CASTLE MODEL 233HC STEAM STERILIZER
  849. K093678PLATELIA ASPERGILLUS EIA MODEL 62793
  850. K801689SONATRON ULTRASONIC DENTAL SCANNER
  851. K082700TEMPORARY COLD.V AND SELF-CURE DENTINE
  852. K883508HERA H
  853. K926570HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878
  854. K190721LongBow Ti
  855. K071424PMAX NEWTRON XS
  856. K952929LD GENERAL PURPOSE DISINFECTANT
  857. K193004Monopolar Cord
  858. K072476THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
  859. K060328PLANMECA PROMAX 3D
  860. K110993FEMCHEC PRESSURE MANAGEMET DEVICE
  861. K033245BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
  862. K250195MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
  863. K896553MEDX CERVICAL EXTENSION TEST & REHAB MACHINE
  864. K223406SmartRelease Endoscopic Soft Tissue Release System
  865. K002777VACUETTE WITH PPACK
  866. K162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…
  867. K844839DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
  868. K021801BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
  869. K840409INFUSION SET-STERILE
  870. K822175ADAPTOR FOR FIBEROPTIC LIGHT SOURCE
  871. K203453BD Hypodermic Syringe
  872. K852978COMFORT - CUF
  873. K902353CUSTOM ITE HEARING AID MODELS F AND L
  874. K993077HOWMEDICA OSTEONICS RESTORATION HA HIP STEM
  875. K020548FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300
  876. K081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO
  877. K820640HOO2D SEAT-INFANT
  878. K925798A-DEC 2545 DUO IC MICRO-CART
  879. K931146SURGICAL DRAPES, MODIFICATION
  880. K242051VersaD Delivery Catheter
  881. K173030Vertera Spine Cohere Cervical Interbody Fusion Device
  882. K230214Huma RPM (RPM)
  883. K240180Orthopeasia Spinal Fixation System
  884. K851397SONICATOR 705 MODEL ME 705
  885. K850588SPQ TEST SYSTEM FOR COMPLEMENT C3
  886. K981224DIRECT HDL
  887. K961519ETEST SUBMISSION FOR AZITHROMYCIN
  888. K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma…
  889. K013787NYCOCARD CRP
  890. K945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEM
  891. K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
  892. K061949DOUBLEPLAY SUTURE ANCHOR
  893. K232392CT Lung Ventilation Analysis Software (CT:V)
  894. K231861EndoflipTM 300 System
  895. K180859PYRAMIDION Dental Implants and Prostheses
  896. K011284THIN FILM DRESSING FOR ULTRASOUND EXAM
  897. K211649PCEA Syringe Set
  898. K923116COMBINE II WETPROOF PAD
  899. K911042GAMMAT ELECTROFORMED GOLD COPING
  900. K091688A-GRIX RESORBABLE BONE VOID FILLER
  901. K910042EBV IGM ELISA TEST
  902. K022794E-SPEED EBT SCANNER SYSTEM
  903. K001314MEDSCOPE
  904. K050448CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
  905. K964850SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
  906. K013311MODIFICATION TO: POCKETVIEW ECG SOFTWARE
  907. K921429SOLUTION ADMINISTRATION SET
  908. K922179CATHETER INSERTION TRAY
  909. K923105MILES URINE AMYLASE METHOD
  910. K983360MACROPORE PROTECTIVE SHEET
  911. K992649ATD AUTOMATIC BRIDGE REMOVER
  912. K924779BURTON KERATOMETER - MODLE 2040
  913. K073109STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM
  914. K935839GEMSCOM SERIES 5000,
  915. K984338JOSTRA HL-20 TWIN PUMP
  916. K052761MODIFICATION TO: XIA 4.5 SPINAL SYSTEM
  917. K760514DISC, WILL-CERUM LIQUID
  918. K912544BIPOLAR FORCEPS
  919. K924264O.R. CONCEPTS CABLE HARNESS
  920. K871567PHENYTOIN FPIA CONTROLS
  921. K914980HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES
  922. K861592WEC-WASH, CATALOG NO. 850-115
  923. K943472COHORT AVB RETRACTOR SYSTEM
  924. K982606AUROFLUID CPF
  925. K140552CADWELL SPIKE AND SEIZURE DETECTOR
  926. K842036BIPHASIC BLOOD CULTURE BOTTLE
  927. K010605ATLAST DATA MANAGEMENT SOFTWARE (DMS)
  928. K131077LIFE SPINE PLATEAU SPACER SYSTEM
  929. K083024HYLATOPIC EMOLLIENT FOAM
  930. K810159BONE MINERAL ANALYZER CONTROLLER
  931. K072144CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE…
  932. K024240BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS
  933. K060887ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
  934. K003191MIS IMPLANT SYSTEM DECIVE
  935. K811772AUDITORY LOCALIZER
  936. K844814BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
  937. K024201NAVIGUS FIDUCIAL MARKER SYSTEM, MODELS FM-1000, FM-2000
  938. K970803ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
  939. K895688NOBLES-LAI ENGINEERING INFUSION PUMP
  940. K884174MODIFIED OLSEN 755/756 SWITCHPENS
  941. K942834ACUFEX UNI-CUT 4. OMM CARPAL TUNNEL CANNULA
  942. K140558PROCTIGARD
  943. K792144DISPOSA-HOOD
  944. K010836AT WORK DRUG TEST, MODEL 9147T AWT
  945. K934403SUNGLASSES
  946. K193194CrossTorq 14 Guidewire
  947. K920307AUSONICS OPUS 1 SYSTEM, ANNULAR ARRAY OPTION
  948. K915724MODEL 6984M LEAD EXTENDER KIT
  949. K965040INTROL BLADDER NECK SUPPORT PROSTHESIS WITH REMOVAL TOOL
  950. K113260MODIFIED CONCENTIRC MICROCATHETER
  951. K760154TEST, (IVDP) THYROID ANTIBODY
  952. K822226ERIKA NEGATIVE PRESSURE VENOUS BLOOD LIN
  953. K820832PHOSPHORUS IL
  954. K013642AVEA
  955. K953496ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES
  956. K121151PRO-LINK CERVICAL SPACER SYSTEM
  957. K102663AED RESECTOSCOPE
  958. K821452DURAZYME CPK
  959. K973049IMCOR EXTERNALLY HEXED, SELF-TAPPING SCREW IMPLANT SURGICAL DRILLING SYSTEM
  960. K870120DIGILAB MODEL 1500 PERIMETER
  961. K771256GAS CHROMATOGRAPH
  962. K022365STRYKER NAVIGATION SYSTEM - HIP MODULE
  963. K923510ALT (GPT) - ALANINE AMINOTRANSFERASE
  964. K970886HANAULUX BLUE 80 HOSPITAL
  965. K032324ECHOENCODER
  966. K171976Sofia Strep A+ FIA, Sofia 2 Analyzer
  967. K000673HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
  968. K963406UHE COLLIMATOR (210591)
  969. K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X
  970. K970831REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK
  971. K903851CLUB FOOT CPM MACHINE
  972. K04285855CM 15.5FR DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER W/SEPARATED TIPS
  973. K220861M6-C Artificial Cervical Disc Instruments AS
  974. K973453TORNIER CEMENT RESTRICTOR
  975. K902579EMIT(R) II COCAINE METABOLITE ASSAY
  976. K882830INFUSION PUMP
  977. K822822GAMBRO PRESSURE MONITOR PRM 10
  978. K032153BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
  979. K132306PERSYST 12 EEG REVIEW AND ANALYSIS SOFTWARE
  980. K203024C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon…
  981. K941711HYPERFLEX FLEXIBLE GUIDEWIRES
  982. K925794TRACE MICROPROTEIN REAGENT
  983. K162815SterilContainer S System
  984. K831051HOME PREGNANCY TEST KIT HPK #1
  985. K012009MX8000 IDT CT SYSTEM
  986. K790080APRON, LEADED VINYL
  987. K181344C.T.M Mobility Scooter
  988. K122822SPECTRUM SPINE LAMINOPLASTY PLATING SYSTEM
  989. K212107Reverso
  990. K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
  991. K090962CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
  992. K213721BriefCase
  993. K082647POWDERED VINYL PATIENT EXAMINATION GLOVES
  994. K922645LSF ANATOMIC CEMENTED HIP
  995. K952799ABBOTT XL3M INFUSION PUMP
  996. K152613True Flow Valvuloplasty Perfusion Catheter
  997. K863805MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME
  998. K891582MODIFIED OSTEOANALYZER (# SPSHA110/220)
  999. K851861PROGRAMALITH III MODEL 249 PULSE GENERATOR
  1000. K260343Carescape Canvas 1000; Carescape Canvas Smart Display

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