FDA 510(k) clearances — page 938
clearances on record, most recent first.
Clearances — page 938
93,701–93,800 of 175,890- K971776 — ECHOVACS
- K971795 — AUTOMATED CHAMBER MAINTENANCE MODULE
- K971926 — QUIKSTRIP ONE STEP COCAINE TEST
- K971945 — PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC SURGICAL GLOVE
- K972190 — THYROGLOBULIN ASSAY SYSTEM
- K972286 — FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
- K972288 — FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
- K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEM
- K972362 — FOVS, BRILLARTE, ETC...
- K970461 — CELL ROBOTICS ER: YAG SURGICAL LASER
- K971105 — MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM
- K971988 — ALLEN, ULTRA AND SMART SOCKETS
- K964190 — ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- K965079 — SOMNITOR 32K SLEEP ACTIVITY MONITOR
- K970051 — MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE
- K970371 — FLOTEC OXYSAVRR (S)
- K970988 — FAR-EAST BOUFFANT CAPS
- K971191 — FAR-EAST SHOE COVERS
- K971546 — SOMA 900 TRANSPORT BED
- K971722 — TRANS VAGINAL NEEDLE GUIDE
- K972006 — ACTA OEM MODULE
- K972078 — POST-STOP EPISTAXIS CATHETER
- K972259 — PRO CHECK DIGITAL PACIFIER THERMOMETER
- K964920 — RPI DUAL PORT IRRIGATION ADAPTER
- K970011 — ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
- K970236 — THERAPLAN PLUS VERSION 1.2
- K971068 — 34MM SCARF THREAD-HEAD(TM) SCREW
- K971069 — TWIST-OFF (TM) SCREW
- K971070 — SCARF THREAD-HEAD (TM) HEAD SCREW
- K971079 — INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
- K971194 — NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
- K971321 — OSTEO COMPRESSION CONDYLE SCREW SYSTEM
- K971332 — AMS MAINSTAY UROLOGIC BONE ANCHOR
- K971337 — EPITECH ISLAND DRESSINGS
- K971358 — BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
- K971381 — POWDER-FREE DURAPRENE STERILE SYNTHETIC SURGICAL GLOVES
- K971404 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER
- K971409 — OSTEONICS ALUMINA C-TAPER HEAD
- K971426 — HEADLOC CERAMIC HEAD
- K971429 — INTERSEAL ACETABULAR SCREW HOLE PLUG
- K971435 — HEADLOC CERAMIC FEMORAL HEADS
- K971654 — OSTEO COMPRESSION HIP SCREW SYSTEM
- K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER
- K971815 — ASC BALANCE MIDDLEWEIGHT GUIDE WIRE
- K972026 — SP4044 & SP4055 LUX MODULES
- K972269 — DISPOSABLE PATIENT RETURN ELECTRODE
- K961732 — KAR
- K970739 — RMI HEMOCONCENTRATOR PREFERENCE PACK
- K971342 — DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
- K971550 — KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
- K971702 — FAR-EAST BARRIER GOWNS
- K972000 — X-RAY ASSIST BAR
- K972001 — NICAS(TM) ELECTRODE
- K972092 — NASAL AIRWAY SPLINT
- K972146 — QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
- K972273 — TBD
- K961734 — CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
- K963249 — EPILIGHT HAIR REMOVAL SYSTEM
- K963848 — MANUAL RESUSCITATOR
- K970318 — OCULAR CONFORMER
- K970319 — OCULAR CONFORMER
- K970320 — SCLERAL SHELL
- K970327 — SCLERAL SHELL
- K970995 — CMS CRYOLITE
- K971060 — PRECINORM TDM CONTROLS
- K971302 — ULTRACISION 5MM LAPAROSONIC HOOK BLADES, ULTRACISION HS2 BLADE
- K971349 — BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
- K971473 — IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK
- K972151 — DOYLE COMBO NASAL AIRWAY SPLINT
- K972287 — DADE TRU-LIQUID BILIRUBIN CONTROL
- K961044 — NOVIGUARD QUICK DRY
- K961465 — 2008H ON LINE CLEARANCE MONITOR
- K962767 — MS401097-17,MS722-K,MS720,MS721,MS722
- K964172 — MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL
- K964873 — SILKAIR LOW AIRLOSS THERAPY
- K965110 — N-ASSAY TIA MULTI CRP CALIBRATOR SET
- K965179 — INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO
- K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
- K965245 — TBD
- K970073 — BIO-ESTHETIC INDIRECT ABUTMENT
- K970191 — UNIJECT EXAMINATION GLOVES
- K970300 — NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
- K970383 — SHARPS CONTAINER
- K970398 — SHARPS CONTAINER
- K970548 — ONE STEP MARIJUANA CARD TEST
- K970579 — ONE STEP MORPHINE CARD TEST
- K971268 — BONE & MARROW CLLECTION SYSTEM
- K971278 — PURE COMPANY FLUID DELIVERY SYSTEM
- K971279 — VERSION 4 OPERATING SYSTEM SOFTWARE
- K971347 — MEDISURF
- K971380 — MEDRAD FLEX INTERFACE DEVICE
- K971448 — CORDIS OPTA LP PTA BALLOON CATHETER
- K971489 — RATATIONAL ANGIOGRAPHY OPTION FOR PHILIPS MULTIDIAGNOST 4
- K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION
- K971631 — CEFOTETAN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K971633 — PIPERACILLIN/TAZOBACTAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K971635 — AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
- K971666 — SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
- K971699 — ARGOSY DYNAMEQ
- K971809 — ISOLATE
Data sourced from openFDA. This site is unofficial and independent of the FDA.