FDA 510(k) clearances — page 976
clearances on record, most recent first.
Clearances — page 976
97,501–97,600 of 176,637- K963188 — DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
- K963218 — BANTEX SURGICAL LATEX GLOVES- TYPE 1 NATURAL RUBBER LATEX SURGICSL GLOVES, STERILE
- K963367 — RMS K-WIRE
- K963516 — VERDICT THC
- K963529 — VERDICT BARBITURATES
- K963543 — SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2
- K963602 — BIODERM PVP FOAM WOUND DRESSING
- K963606 — VISUALINE COMBO V (COCAINE/THC) TEST
- K963666 — INSTANT COLD PACK
- K963816 — LEVO COMPACT LC
- K963827 — AXSYM FREE TRIIODOTHYRONINE (FREE T3)
- K963833 — IMX FREE TRIIODOTHYRONINE (FREE T3)
- K960431 — PRESSURE STOPCOCK/MANIFOLD
- K961595 — DEFIBRILLATOR ANALYZER, DELTA 1000
- K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM
- K961833 — SONOLINE ELEGRA WITH SIESCAPE FEATURE
- K962158 — PICO MODELS 30, 50, 70
- K962178 — BARD TIGER GUIDEWIRE MODEL 000540
- K962269 — CEDIA CARDIAC TDM MULTI-CALS
- K962292 — HEARSAVER
- K962724 — STERILE LATEX SURGICAL, SOLD UNDER BRAND NAMES SAVACARE AND ROGUMED
- K962859 — MINI SAMPLE PROCESSOR
- K962892 — HELAX TMS BRACHYTHERAPY, VERSION 3.0
- K963144 — GC BASELINE
- K963205 — ALGINMAX, ORTHOCHROME
- K963306 — CEDIA N-ACETYLPROCAINAMIDE ASSAY
- K963378 — MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER
- K963504 — MEDLINE OPEN END FINGER CONTROL MITT
- K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)
- K963533 — SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
- K963751 — PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
- K963797 — PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
- K954448 — VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
- K954788 — EUREDUC PNEUMATIC DRAINAGE SYSTEM
- K960299 — PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE
- K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30
- K961054 — SYSMEX UF-100
- K961341 — CONVERTORS POLYOLEFIN FABRIC GOWNS
- K961425 — BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER SEQUENTIAL MODELS
- K961426 — BIO BOOST
- K961432 — RADIAS GALT TEST
- K961677 — ACUPUNCTURE NEEDLES
- K962190 — PATELLOFEMORAL JOINT PROSTHESIS
- K962714 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
- K962955 — GAMMACON IMAGE TRANSLATION SYSTEM
- K962967 — FUJI MEDICAL DRY IMAGER FM-DP 2636
- K963026 — TBD
- K963219 — RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES
- K963287 — VACUUM CUP (004SD)
- K963526 — STRAP WEDGE
- K963740 — LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
- K963818 — OVATION AGC-2
- K963819 — OVATION ASP
- K963820 — OVATION LINEAR
- K963821 — OVATION AGC-1
- K963822 — OVATION AGC-3
- K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
- K953210 — GLUCOSE (HEXOKINASE) KIT
- K960010 — SERVO VENTILATOR 300 COMPUTER INTERFACE
- K960159 — CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)
- K960168 — SIEMENS SERVO SCREEN 390 AND SERVO COMPUTER MODULE 990
- K960486 — KSEA MODEL 383320 20 ANGIOMAT
- K960571 — RAPID ELECTROPHORESIS ANALYZER
- K960985 — SLS-CT
- K961418 — OSTEOMED MSS
- K962225 — VIEWSEND MEDICAL MODEL 1200
- K962675 — STA - LIATEST VWF TEST KIT
- K962865 — REMBRANDT SYSTEM
- K962924 — PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
- K962925 — OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
- K962932 — CORDIS STABILIZER PLUS XS
- K962933 — OPART MRT-600
- K962938 — EXCELSIOR DISPOSABLE SYRINGE W/NORMAL SALINE (.9% SODIUM CHLORIDE)
- K962948 — CERALAS G ND; YAG LASER SYSTEM (CERALAS G)
- K963096 — ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
- K963173 — STEALTHSTATION SYSTEM
- K963265 — PROSYS SAMEC LA
- K963329 — ETHICON ENDOSUTURE SYSTEM
- K963395 — IMAGESERVER 2000 PICTURE ARCHIVING SYSTEM
- K963619 — GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
- K963623 — SPYROFLEX PIGMENTED WOUND DRESSING
- K963845 — MEROPENEM, 10 MCG, SENSI-DISC
- K950686 — I.V. START KIT
- K955553 — PERFECTA REVISION HIP SYSTEM
- K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS
- K955923 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL
- K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY
- K960367 — INCSTAR RUBELLA IGG ELISA ASSAY
- K961864 — CSF/URINE TOTAL PROTEIN
- K962334 — EML105 ELECTROLYTE METABOLITE ANALYZER
- K962929 — PERSONAL BEST II
- K962963 — CHECKMATE ANKLE RESTRAINT SYSTEM
- K962964 — HEELBO JOHNNY GRAIT BELT SECURITY BELT
- K963107 — ETEST FOR CEFEPIME
- K963110 — JETLITE
- K963209 — PROSTYLE COMPACT
- K963514 — PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
- K963537 — SIGMA DIAGNOSTICS BUN REAGENT
- K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT
- K963560 — MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
Data sourced from openFDA. This site is unofficial and independent of the FDA.