FDA 510(k) clearances — page 1005
clearances on record, most recent first.
Clearances — page 1005
100,401–100,500 of 175,890- K951823 — CRYO CHECK LOW FIBRINOGEN CONTROL
- K952260 — OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
- K955185 — GE ADVANTAGE DICOM CR REPROCESSING STATION
- K955442 — KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
- K955539 — UNISUN
- K955611 — KMANZ II
- K952527 — BALLOON UTERINE STENT
- K952541 — PACIFIER THERMOMETER
- K954020 — MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
- K954631 — OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE
- K954875 — ASPECT ACQUISITION MODULE (AAM)
- K955331 — BELLEGLASHP
- K955759 — LITEX 680
- K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
- K951593 — LIFEPAK 11
- K952320 — PYRILINKS-D ASSAY KIT
- K953877 — MITEK GII ANCHOR
- K954420 — AXSYM DIGITOXIN
- K954438 — SUNMED'S GREENLINE FIBER OPTIC LARYNGOSCOPE
- K954446 — AUGUSTINE INTUBATION GUIDE
- K954480 — CONDENSATE COLLECTION KIT
- K954529 — AUTOMATED TRU-CUT BIOPSY DEVICE
- K955105 — BTE CPM-10
- K955106 — BTE CPM-20
- K955142 — DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A
- K955390 — INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY
- K955609 — CONVEEN URINE BAG - STERILE
- K922600 — FUTREX-5000
- K922601 — FUTREX-5000A
- K941627 — A&D UN-231 ULTRASONIC HANDY NEBULIZER
- K942977 — NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE
- K943106 — ADULT VENTILATOR
- K945774 — BETA FEMORAL HIP STEM
- K946219 — POP-N-LOK SYRINGE
- K950555 — J SINGLE USE HEAD AND JD REUSABLE HANDLE
- K952494 — DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
- K952731 — TOWNLEY ALL POLY ACETABULAR CUP
- K952787 — FOAM INSTRUMENT GUARD
- K953358 — SURGEONS GLOVE POWDER FREE
- K953936 — ATLANTIS
- K954271 — WESTMED CONDESATE COLLECTION TRAP
- K954314 — ULTRAFIT LINERS
- K954546 — BLOOD GAS MIXTURE
- K954595 — CORDIS BRITE TIP SHEATH INTRODUCER
- K954637 — AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER
- K954641 — ENDO-LEADER
- K954855 — POWDER FREE PLUS PATIENT EXAMINATION GLOVE
- K954915 — FLEXIBLE INTRAMEDULLARY REAMER
- K954964 — AQUACENTER 2000 SYSTEM
- K955279 — D-SENSE
- K955406 — SCAN WHITE 12 ML
- K955465 — DEGUPRINT
- K955509 — MIDAS GOLD ELECTROFORMING SYSTEM
- K955530 — RANIR HI-TECHNOLOGY DENTAL FLOSS
- K951910 — ODYSSEY HO:YAG SURGICAL LASER SYSTEMS & ACCESSORIES
- K954275 — MEPORE PLUS (9X15CM)
- K950621 — BIOFILL BIOCELLULOSE DRESSING STERILE
- K951223 — CK-MB (NAC-ACT)
- K952576 — TRANSPORT CART
- K953129 — ESP CULTURE SYSTEM - MYCO
- K953538 — RM001 REUSABLE
- K953539 — DM001 DISPOSABLE PACK
- K954392 — HYTEC AUTOIMMUNE KIT (SS-A)
- K954551 — DF-1 TERMINAL CAP
- K954608 — CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH
- K954890 — HYTEC AUTOMMUNE KIT (ENA)
- K954891 — HYTEC AUTOIMMUNE KITS (SS-B)
- K954892 — HYTEC AUTOMIMMUNE KIT (RF)
- K954918 — COMBIDERM ACD
- K955340 — EUROTROL GAS - ISE CONTROL
- K955439 — THE REEL THING (MODIFICATION)
- K941352 — SSA-340A
- K942265 — FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH
- K943896 — GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
- K945945 — GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT
- K946230 — ENDURA REUSABLE TENS AND NMES ELECTRODES
- K951429 — FLEXIFLO 6.1 ENTERAL NUTRITION PUMP
- K952343 — FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
- K952889 — INSUL-COAT/2 CERAMIC COATED ENDO MEDICAL INSTRUMENTS
- K953098 — VOLUMETRIC INFUSION PUMP
- K953384 — Multi Side Hole lnfusion System
- K953942 — COBRASCAN CX-312
- K953997 — ROTABLATOR ROTATIONAL ANGIOPLASTY
- K954129 — SPECTRADIGITAL SERIES V250DSP
- K954143 — HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
- K954306 — GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
- K954307 — GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
- K954308 — GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
- K954383 — SURELOC CIRCUIT CONNECTOR
- K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLE
- K954542 — LUNG DIFFUSION MIXTURE
- K954562 — GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT
- K954601 — NERVE LOCATOR/MONITOR SYSTEM MODIFICATION
- K954634 — RADIOSURGERY VERIFICATION PHANTOM
- K954649 — WGL ENDOSCOPIC GRASPER W/DETACHABLE STRAP
- K954941 — MIRACLE EAR AND AUDIOTONE
- K954949 — TRANSIT INFUSION CATHETER WITH SIDEHOLES
- K955036 — MOBILE X-RAY SYSTEM
- K955069 — PLAYSKOOL
- K955249 — SENSOR PAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.