FDA 510(k) clearances — page 847
clearances on record, most recent first.
Clearances — page 847
84,601–84,700 of 176,637- K992657 — IBC VRV, MODEL 1350
- K993951 — SPOT ENDOSCOPIC MARKER
- K993965 — CRYO-HIT
- K993966 — 8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
- K994076 — IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY
- K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D
- K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118
- K994143 — SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES]
- K994244 — CONVERTORS SURGICAL GOWNS, STERILE
- K994298 — FRIOS MICROSAW
- K994361 — ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
- K994379 — EU-TTG IGA ELISA
- K994424 — DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM
- K000022 — HARDYDISK CEFAMANDOLE, 30MCG
- K000119 — SJM TAILOR ANNULOPLASTY RING, MODEL TARN
- K991737 — LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
- K992556 — PERMACOL
- K994134 — HARDYDISK OXACILLIN, 1MCG
- K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
- K000236 — SYNERGY VLS CAP NUT MODELS 2206, 6102
- K000242 — ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE
- K000295 — ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000334 — IMPACT MODULAR TOTAL HIP SYSTEM
- K000379 — MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
- K981936 — ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
- K984565 — TMC-EASY-302
- K992751 — SOMAVISION
- K993332 — GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
- K993846 — ULTRASEAL XT PLUS
- K993872 — VANNA BATHING SYSTEM
- K994012 — TEMPOFIT, MODEL 02693
- K994135 — HARDYDISK ERYTHROMYCIN, 15MCG
- K994150 — HARDYDISK NORFLOXACIN, 10MCG
- K994314 — CASTLE SERIES 100HC STEAM STERILIZERS
- K994425 — MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM
- K994432 — HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
- DEN990008 — WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-4000
- K000116 — QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
- K000300 — LIGHTSPEED 2.0CT SCANNER SYSTEM
- K000310 — VOYAGER 6.0 SOFTWARE OPTION
- K991395 — QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
- K991396 — WATER FOR TISSUE CULTURE, MODELS 500 L & 1.5 L
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K993395 — REMED MALE LATEX CONDOM (DOUBLE WHOOPER) PREVENTOR, LUCKY BOY AND SUMMIT
- K993396 — REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
- K993404 — REMED MALE LATEX CONDOM (CLASSIC) PREVENTOR, LUCKY BOY, AND SUMMIT
- K993405 — REMED MALE DOTTED CONDOM PREVENTOR, LUCKY BOY, SUMMIT
- K993408 — REMED MALE RIBBED CONDOM PREVENTOR, LUCKY BOY SUMMIT
- K994154 — MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES
- K994159 — HMP CONTROLS (TAS) RAPIDPOINT
- K994184 — PLR SPLINED REVISION STEM
- K994212 — HARDYDISK MEZLOCILLIN 75MCG
- K000170 — SECCA TUBULAR ELECTRODE DEVICE, MODEL A4000
- K000185 — GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)
- K992699 — NIPRO BLOOD COLLECTION NEEDLE
- K993037 — LCV+ VERSION 2
- K993390 — REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT
- K993881 — GENX CULTURE DISH
- K993884 — GENX MICROTOOLS
- K993903 — WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013
- K993958 — IDX-60 INTRAORAL X-RAY
- K993959 — ISOCENTRIC BEAM CHECKER
- K993960 — PERMA-DOC PHANTOM
- K993995 — VEIN ENTRY INDICATOR DEVICE (VEID)
- K994054 — ISSA PHAROS
- K994061 — LOCON-T DISTAL RADIAL PLATE
- K994345 — MAGNA 5000 PHASED ARRAY CTL SPINE COIL
- K000144 — NIPRO INSULIN SYRINGE
- K000184 — AUDIOSCREENER OAE
- K000225 — CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
- K000256 — CAP PORP, CAP TORP
- K983928 — KODAK HOME HEALTH MONITORING SYSTEM
- K991397 — TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS
- K993224 — T-GEAR, MODEL TG/400-700
- K993436 — CAVERMAP SURGICAL AID
- K993704 — GASTRO-INTESTINAL SYSTEM EN-410WM
- K993889 — EXETER CERAMIC FEMORAL HEADS
- K994089 — HARDYDISK CHLORAMPHENICOL, 30MCG
- K994091 — HARDYDISK GENTAMICIN, 10MCG
- K994129 — HARDYDISK CEFIXIME, 5MCG
- K000017 — PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
- K000052 — X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
- K000090 — GUTHRIE PRIME POWDER-FREE CHLORINATED PATIENT EXAMINATION GLOVES
- K000101 — RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
- K000186 — DATEX-OHMEDA INOVENT DELIVERY SYSTEM
- K000274 — EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
- K000331 — SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
- K992039 — EXEL I.V. BLOOD LINE SET
- K992176 — EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL
- K992467 — IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM
- K992571 — I-STAT SYSTEM
- K992689 — MU PLUS
- K993184 — R1000 SERIES INSULIN PUMP
- K993190 — ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
- K993291 — COPALIS RUBELLA IGM
- K993554 — YEASTEST
- K993861 — FUJI COMPUTED RADIOGRAPHY DUAL SIDE READING, BOTH SIDE READING, FCR 5501D DUAL SIDE READER
- K993885 — ULTRABLATOR ELECTRODE
- K993893 — MEDX INTECAM INTERFACE
- K993918 — HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
Data sourced from openFDA. This site is unofficial and independent of the FDA.