FDA 510(k) clearances — page 714
clearances on record, most recent first.
Clearances — page 714
71,301–71,400 of 175,825- K032134 — TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
- K032271 — WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
- K032280 — SIREMOBIL ISO-C 3D
- K032399 — VITEK 2 GRAM POSITIVE MOXIFLOXACIN
- K032404 — SELDINGER SAFETY NEEDLE INTRODUCER
- K032535 — MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
- K032548 — IP-XS COMPRESSION NAIL SYSTEM
- K032624 — MICRUS MICROCATHETER
- K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
- K030563 — ARABELLA NCPAP MASKS
- K030622 — AXIOM BIOLASER LLLT SERIES-1
- K030701 — IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
- K030702 — IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
- K031805 — BLU-U, MODEL 4170
- K031810 — AMPLATZER VASCULAR PLUG
- K031849 — SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
- K031970 — INFINITY MEGACARE
- K032122 — AUDIT MICROCONTROLS MICROFD BNP CONTROL
- K032149 — RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
- K032179 — COMP. E
- K032233 — MEDLEY PCA MODULE, MODEL 8120
- K032238 — TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
- K032492 — BLOOD PRESSURE MONITOR, MODEL KP-7000
- K032525 — BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
- K032528 — BD ECLIPSE BIFURCATED NEEDLE
- K032557 — TRIUMPH VTX WITH LIFEVALVE CATHETER
- K032600 — VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
- K021471 — MARQUETTE HUBER TRAP SAFETY INFUSION SET
- K023582 — I-STAT KAOLIN ACT TEST
- K031108 — SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
- K031377 — SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
- K031850 — DURASIS DURAL SUBSTITUTE
- K032039 — IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K032524 — ADVIA 60 HEMATOLOGY ANALYZER
- K032549 — MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
- K023354 — COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
- K031764 — ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
- K031772 — TI FENESTRATED PLATE
- K031882 — ENDOSCOPIC APPLICATOR
- K031938 — GEL MARK III BIOPSY SITE MARKER
- K031964 — BPCARD
- K031973 — SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
- K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
- K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
- K032159 — CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
- K032237 — N/T PROTEIN CONTROL
- K032365 — BENZODIAZEPINE ENZYME IMMUNOASSAY
- K032430 — ACUEITY MEDICAL LIGHT SOURCE
- K032494 — PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
- K032507 — INTERLOK BIO-MODULAR HUMERAL STEMS
- K032589 — ENCLOSE II ANASTOMOSIS ASSIST DEVICE
- K032594 — ONE DIMENSIONAL WATER PHANTOM, WP 1D
- K030629 — DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
- K031313 — TMC ELECTRICAL SCOOTER, EASY 405
- K031314 — TMC ELECTRICAL SCOOTER, EASY 411
- K031315 — TMC ELECTRICAL SCOOTER, EASY 321
- K031785 — MACROPORE CARDIO-WRAP (TS)
- K031811 — PIT & FISSURE SEALANT WITH FLUORIDE
- K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
- K031919 — EBI XFIX DFS SYSTEM
- K031937 — ALANTECH GRAFT FIXATION SCREW
- K032032 — SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
- K032037 — CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
- K032136 — WIROBOND C
- K032457 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K032479 — HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
- K032491 — ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR
- K032493 — ALEXANDER
- K030630 — EDWARDS DIRECTIONAL CATHETER
- K030652 — MEDRO SPD
- K030662 — PATHWAY ACCESS SHEATH CATHETER
- K031691 — MERIT MAK (MINI ACCESS KIT)
- K031761 — SYNTHES (USA) NEW/STERIAL ORBITAL PLATES
- K031833 — MODIFICATION TO CD HORIZON SPINAL SYSTEM
- K032012 — HOMOCYSTEINE MICROTITER PLATE ASSAY
- K032173 — FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
- K032345 — CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
- K032622 — ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS
- K023722 — SAFETYWAND DISPOSABLE HANDPIECE
- K030328 — VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
- K030553 — ARKIT HBA1C
- K030633 — MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
- K031729 — TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
- K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST
- K031758 — ACMI M4 TELESCOPES
- K032020 — 51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW
- K032022 — DIGITAL IMAGER
- K032156 — ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
- K032544 — VP-1000; MED CAM 100; VP-3000A; MED CAM 300
- K032545 — ENDOSCOPIC LIGHT SOURCE LS-3000X; LS-1800XG/MED LIGHT X 180; LS-2500H/MED LIGHT H 250
- K020419 — V SET
- K020424 — V SET
- K024313 — MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
- K030066 — CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165
- K030237 — KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
- K030379 — APLAB, MODEL 801D0030
- K030441 — SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
- K030742 — POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
- K031634 — OMNIPRO I'MRT
- K031694 — MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000
Data sourced from openFDA. This site is unofficial and independent of the FDA.