FDA 510(k) clearances — page 840
clearances on record, most recent first.
Clearances — page 840
83,901–84,000 of 175,890- 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
- K993978 — PR3 ULTRASOUND SYSTEM
- K994196 — HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
- K994218 — EASY CARE AND TUBING SETS
- K994300 — NASOGASTRIC TUBE HOLDER, MODEL 160
- K994343 — BACT/ALERT SV
- K994435 — OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS
- DEN000002 — UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
- K992930 — BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
- K992979 — SHANGHAI POSEIDON POWDER-FREE SYNTHETIC VINYL EXAMINATION GLOVES, YELLOW
- K993754 — HSV-1 ELISA IGG, MODEL EL0910G
- K993832 — AUTODOSE INFUSION SYSTEM, MODEL AD4120, BE4210, S12050,100,200, FF0005, 10
- K993912 — AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI
- K994001 — POLYGLYCOLIC ACID
- K994162 — POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
- K000094 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K000102 — GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
- K000153 — ARTHRO-SURGIMAT-A103
- K992739 — CLICK'X
- K993818 — ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
- K994172 — CEREC 3
- K994176 — SUTRALON NYLON SUTURES
- K994177 — SUTRASILK SILK SUTURE
- K994191 — SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T
- K994262 — FRONTAL SINUS TREPHINATION CANNULA
- K994336 — BITX PROBES
- K000149 — NOVABONE-BIOGLASS BONE GRAFT PARTICULATE
- K000254 — PAR 5 ACETABULAR COMPONENT
- K991392 — HUMAN SERUM ALBUMIN
- K992815 — THE MARGRON HIP REPLACEMENT SYSTEM
- K992854 — ARTIFICIAL TEETH (ACRYLIC TEETH)
- K993794 — PLATEX ODER ABSORBING GENTLE GLIDE, SLIMFITS AND SILK GLIDE TAMPONS
- K993801 — GYNECARE LAPAROSCOPIC MORCELLATOR
- K993804 — KSEA RIGID CULDOSCOPE AND ACCESSORIES
- K993876 — POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
- K993972 — DISPOSABLE INFUSION PUMP KIT
- K994131 — AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)
- K994201 — RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
- K994206 — SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
- K994222 — SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, BEIGE COLOR
- K994250 — TEKMEDIC POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K994255 — LATEX EXAMINATION GLOVES-PRE-POWDERED-STERILE
- K994302 — RESIN TOOTH BONDING AGENT
- K994304 — ARABESK FLOW
- K993803 — EXCELART WITH PIANISSIMO
- K000015 — BARCOMED 2MP2
- K000036 — ENTEC REFLEX WAND 55, MODEL E4055-00
- K000074 — ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD, PLASMA SCALPEL GS, TURBOVAC GS
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