FDA 510(k) clearances — page 861
clearances on record, most recent first.
Clearances — page 861
86,001–86,100 of 175,890- K992167 — PERFORMANCE KNEE SYSTEM
- K992197 — MODIFICATION TO ZYMED HOLTER 2000
- K984627 — AVE 4F SITESEER CARDIOVASCULAR ANGIOGRAPHIC CATHETER
- K991517 — CRYO-HIT II, MODELS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
- K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE
- K984060 — LUER ACCESS INJECTION SITE
- K984428 — SULLIVAN AUTOSET NASAL CPAP SYSTEM
- K990348 — WALLACE TRIAL TRANSFER CATHETER, MODEL TT 1816N
- K990349 — WALLACE MALLEABLE STYLET-18CM, MODEL 1816ST, WALLACE MALLEABLE STYLET-23CM, MODEL 1816NST
- K990350 — WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
- K991065 — CARESIDE PT
- K991110 — REDI-TEST COCAINE
- K991322 — ENHANCE-S PLUS
- K991607 — VANTAGE 2.5
- K991631 — FASTRAY LC
- K991668 — COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12)
- K991902 — LC PIT & FISSURE SEALANT
- K991913 — PENTAMIX 2
- K991951 — SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
- K992020 — BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDERED)
- K992216 — BIOMEND EXTEND ABSORBABLE COLLAGEN MEMBRANE, BIOMEND ABSORBABLE COLLAGEN MENBRANE
- K992244 — GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE
- K980070 — OSTEONICS HA-COATED DEVICES
- K990579 — CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
- K990618 — VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
- K990732 — LAP-WAVE 3000 (P07)
- K990823 — PVS 1400 GUIDEWIRE
- K991446 — BIOSACA SYSTEM, MODEL 800
- K991586 — SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
- K992021 — BRIGHTWAY BRAND LATEX SURGICAL GLOVES - STERILE (POWDER FREE)
- K992034 — DOCUMENT THYROID CAL*VER
- K992041 — RELISA ANA SCREENING TEST SYSTEM, MODEL 7096-11
- K992205 — PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
- K992231 — FOUNTAIN Infusion Catheter and Occluding Guide Wire
- K990476 — HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, MODEL REV. K WITH EASI-ECG OPTION
- K991424 — INSULSCAN INSULATION TESTING SYSTEM
- K991449 — SNORE-AID PLUS
- K991504 — REDI-TEST METHAMPHETAMINE
- K991597 — COBAS INTEGRA AMIKACIN MAB
- K991598 — COBAS INTEGRA ACETAMINOPHEN
- K991723 — TRANSFX MULTI PIN CLAMP
- K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027
- K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
- K992207 — QUIKSTRIP ONE STEP COCAINE ASSAY (COCAINE AND COCAINE METABOLITE TEST SYSTEM
- K984392 — ANSELL CONDOMS
- K991557 — MEDRAD VISTRON CT INJECTOR SYSTEM
- K991588 — EMS SWISS ORTHOCLAST
- K991844 — PRO-GLASS
- K992142 — SCIMED ANGIOGRAPHIC CATHETERS
- K992328 — FUZZY AUTOMATIC BLOOD PRESSURE MONITOR MODELS MD-750, MD-770, MD-800
- K984180 — THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM
- K990342 — SYNOCTA PROSTHETICS
- K990656 — CHROMOPHARE D 530 LDR SURGICAL LIGHT
- K990712 — OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM
- K991416 — ENDOSCOPIC CAMERA
- K991464 — DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50
- K991469 — AWARE PAD
- K991525 — DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
- K991608 — DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
- K991609 — DERMAPHYLYX SUPER ABSORBENT FIBER DRESSING
- K991636 — ELEKTA STEREOTACTIC GUIDE
- K991860 — SYNTHES CRANIAL FLAP TWIST CLAMP
- K991865 — Q-LITE 75 LIGHT CURE UNIT
- K991957 — CICACARE MANAGEMENT FOR SCARS
- K992000 — SYNTHES CRANIAL FLAP TUBE CLAMP
- K990597 — SUMMER'S EVE LUBRICATING JELLY
- K991104 — MICROTOOLS
- K991173 — <GENX> FERTILIZATION MEDIA-HTF
- K991367 — MEDITRON STETHOSCOPE SYSTEM
- K991408 — FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
- K991568 — MR SPECTROSCOPY PACKAGE
- K991700 — SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO
- K991827 — GINRAM SPECUVAG, GINRAM SPECUVAG AS, GINRAM CUSCOVAG, MODELS 720101, 720102, 720103, 720179, 720227, 720043
- K991863 — CUTE-LITE I LIGHT CURE UNIT
- K991403 — SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
- K991514 — GEBAUER'S CHLORIDE FINE NOZZE
- K991727 — STAT PROFILE M7 ANALYZER
- K983940 — EZ-INTRO PERCUTANEOUS CATHETER SHEATH, EZ-INTRO VESSEL DILATOR
- K984528 — PARKER FLEX-TIP TRACHEAL TUBE
- K990304 — MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM
- K990524 — E9000 SYSTEM
- K990681 — DBSET MULTIDRUG SCREEN TEST KIT
- K990820 — RAPIDONE - OPIATES TEST
- K990822 — RAPIDONE - COCAINE TEST
- K991001 — MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
- K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101
- K991389 — ANORECTAL MANOMETRY SUITE, MODEL 9032S0201
- K991489 — ALGINATE IMPRESSION MATERIAL I (FAST & REGULAR SET)
- K991490 — ALGINATE IMPRESSION MATERIAL II (FAST & REGULAR SET)
- K991694 — DYNAREX DRAIN SPONGE
- K991695 — DYNAREX NON-WOVEN SPONGE
- K991705 — N PROTEIN STANDARD UY
- K992122 — TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
- K980380 — NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
- K983660 — EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)
- K984563 — THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
- K990068 — SOLAR 9500 INFORMATION MONITOR
- K990341 — ELECTRO MECHANICAL LITHOTRIPTOR
- K990847 — INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M
- K990941 — NEWLIFE DISH (ETCHED OR NON-ETCHED, WITH OR WITHOUT LID), MODELS 14-52, 1452E, 1452EL, 1452L
Data sourced from openFDA. This site is unofficial and independent of the FDA.