FDA 510(k) clearances — page 1437
clearances on record, most recent first.
Clearances — page 1437
143,601–143,700 of 175,890- K861695 — SURGICAL PLASTERS
- K861958 — REPLIANALYZER
- K862028 — ULTRAHESIVE II POSTOP ELECTRODE
- K862241 — STANDARD BASIN KIT CUSTOM BASIN KIT
- K862370 — DART AMYLASE-D.S. REAGENT SYSTEM
- K862473 — PDQ AMEBIASIS
- K862513 — EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS
- K862523 — MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
- K862533 — MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE
- K862589 — ULTRATHERM 808 I
- K862604 — 7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
- K862621 — I22 INITIALES
- K862622 — I22 CITE
- K862624 — I81 CITE
- K862627 — SONORANGER TRANSVAGINAL PROBE
- K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE)
- K862709 — MECHANICAL CYSTITOME
- K862725 — SACCOMANNO SPECIMAN SOLUTION
- K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS
- K862731 — STA-SOF BREAST COMPRESSOR-CLAMP
- K862734 — CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND
- K862754 — CUSTOM IN-THE-EAR AND CANAL HEARING AID
- K862781 — MP-XMM DISPOSABLE FACE MASK
- K862782 — MP-XML DISPOSABLE FACE MASK
- K862783 — MP-XMV DISPOSABLE FACE MASK
- K862784 — MP-XMO DISPOSABLE FACE MASK
- K862785 — MP-1204 DISPOSABLE BACTERIA FILTER
- K862786 — MP-50T DISPOSABLE BREATHING CIRCUIT FILTER
- K862787 — MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER
- K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL
- K862789 — MP-01X DISPOSABLE BACTERIA FILTER KIT
- K862790 — MP-01X-I DISPOSABLE FILTER KIT
- K862791 — MP-30XM-IE FACE MASK AND FILTER KIT
- K862792 — MP-066 RADIOAEROSOL KIT
- K862793 — MP-066-M RADIOAEROSOL KIT
- K862794 — MP-070 RADIOAEROSOL KIT
- K862795 — MP-070-M RADIOAEROSOL KIT
- K862802 — MULTI-CHANNEL MICROPIPETTES
- K862826 — ITT INTERGRATED TABLE AND TUBESTAND
- K862827 — FCW TUBE STAND
- K862828 — BSX BUCKY-STAND
- K861527 — COMET COSMIC 203/218
- K861539 — NIKKISO INFUSION PUMP MODEL PFA-02
- K861858 — VAGINAL CHAMBER PELLETHANE-MEDICAL GRADE 2363
- K861931 — 645OB SECTOR/LINEAR ULTRASOUND SCANNER
- K862302 — BLOOD PLATELET ASSAY METHOD & APPARATUS
- K862410 — MILEX KEGEL PERINEAL EXERCISER
- K862480 — BT CATH (INTRAVASCULAR CATHETER)
- K862653 — LUER LOCK ADAPTER/NUT
- K862660 — PRISMA METAL OPAQUERS
- K862667 — COBALT, 29.5% CHROMIUM ALLOY DENTAL BAKE-ON ALLOY
- K862670 — RIONET HEARING AID HB-35PT
- K862695 — FLUOR-ETCH GEL ETCHANT
- K862745 — EUGENOL USP
- K862760 — HEARING AID, UNITRON MODEL UF11
- K860689 — SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
- K861358 — PS SYSTEM WITH SD-200 DOPPLER
- K861579 — ACUSON L558 TRANSDUCER
- K861596 — ACUSON S519 TRANSDUCER
- K862269 — LAURIER SANTARY NAPKIN (MODIFICATION)
- K862494 — POLYESTER SPONGE PATTIE
- K862582 — TREACE MEDICAL MICRO INSTRUMENT WIPE
- K862656 — PACEMAKER LEAD ADAPTER
- K862663 — TRACHEOSTOMY CARE TRAY
- K862664 — JEDMED CCD CAMERA SYSTEM
- K862696 — TEMPORARY HEMO CLIP, 07-096-01/02 & APPLY FORCEP
- K862702 — TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS
- K862717 — HAND MIRROR (ENDOSCOPE)
- K860538 — RIGHT-DAY URINARY LH (EIA)
- K860766 — MILLAR PULSED DOPPLER VELOCIMETER
- K861703 — LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)
- K861786 — DU PONT DRUG CALIBRATOR
- K861792 — TWIN GOT-AST IFCC/GPT-ALT IFCC
- K862061 — OSTEOGRAF/AR+ PERMARIDGE HYDROXYLAPATITE, 18-40
- K862232 — PANAVIA TC, AND PANAVIA OPAQUE
- K862247 — TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
- K862253 — IL 482 CO-OXIMETER
- K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)
- K862262 — HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
- K862274 — ANALYST ANALYTICAL TEST ROTORS
- K862300 — AMRESCO FLOW PAC SODIUM POTASSIUM REAGENT
- K862506 — THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR
- K862541 — LIQUID CHROMATOGRAPHY COLUMNS
- K862652 — EMIT VALPROIC ACID ASSAY
- K862682 — MVP GENERATOR, CATALOG NO. H8018
- K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS
- K862738 — DANIEL ORTHO BED LIFT AC
- K862741 — Q50 MEDICAL TREADMILL
- K861026 — LIBAN INTUBATOR
- K862194 — INHALATOR MODELS 8100, 10100 AND 10200
- K862380 — MATTRESS COVER
- K862691 — STOPCOCK
- K860163 — BICONDYLAR TOE PROSTHESIS
- K861173 — OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
- K861429 — DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE
- K861456 — SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR
- K861733 — ADDITIONAL KYOTEST URINE TEST REAGENT STRIPS
- K861941 — COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
- K861942 — COLLIMATOR MODEL A280BLE & MODEL A280-BLM
- K862279 — EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.