FDA 510(k) clearances — page 572
clearances on record, most recent first.
Clearances — page 572
57,101–57,200 of 175,825- K071794 — 15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)
- K072632 — QUANTA PLEX CELIAC IGG PROFILE
- K072981 — SYNTHES ZERO-P
- K073149 — MENISCAL CINCH
- K073290 — ARTIS ZEE AND ZEEGO
- K073435 — KODAK 9000, KODAK 9000 3D
- K073487 — OLYMPUS IGM REAGENT
- K073489 — OLYMPUS IGA REAGENT
- K073490 — OLYMPUS IGG REAGENT
- K073510 — ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
- K080062 — OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120
- K070126 — OCCLUSION BALLOON CATHETER
- K071557 — COLLAWOUND HYDROGEL
- K071560 — PROVENT NASAL DILATOR, MODEL BR2
- K072228 — SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
- K072534 — BIO-MAT 2000
- K072757 — DIVE AND SHALLOW AND GRAND DIVE
- K072942 — MEDLINE DISPOSABLE VAGINAL SPECULUM
- K072947 — SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
- K072993 — REUSABLE HEADREST WITH NASAL SEAL
- K073024 — MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
- K073162 — SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING
- K073188 — HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
- K073241 — VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
- K073243 — LED PRO SEAL
- K073268 — BIOHORIZONS INTERNAL IMPLANT SYSTEM
- K073347 — DYNESYS TOP-LOADING SPINAL SYSTEM
- K073366 — TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031 AND DT1041
- K073446 — GRIND GUARD
- K080160 — APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
- K080169 — HEARTSTRING III PROXIMAL SEAL SYSTEM
- K080173 — STAR 55
- K080249 — FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
- K033484 — HUMAN HEART VALVE, CRYOVALVE SG
- K070761 — SANATMETAL NAILS AND PINS
- K072005 — RK EPIDURAL NEEDLE
- K072627 — INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER
- K073003 — SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
- K073096 — ANCHORAGE CLOSURE DEVICE
- K073320 — CIMPLICITY SPINAL SYSTEM
- K073438 — PROSTIM 1000/2000
- K073533 — SANARUS V2 TREATMENT SYSTEM
- K080071 — SIDEKICK RAIL FIXATOR
- K080240 — CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
- K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
- K071148 — ATLAS IMPLANT SYSTEM
- K072412 — OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
- K072656 — DYNASTY CERAMIC FEMORAL HEAD
- K072899 — ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
- K073110 — MERITS E600 SERIES STAIR LIFT
- K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
- K073568 — PSL BIOZIR BLOCK
- K073650 — FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
- K080048 — MSK EXTREME MR SCANNER, MODEL AA5000
- K080265 — DENFIL ETCHANT-37
- K080266 — WELL-PEX
- K072189 — PATHFAST NTPROBNP AND D-DIMER TESTS
- K072254 — VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
- K072437 — ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
- K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
- K080016 — NRBC-CHEX FOR ADVIA
- K080091 — MODIFICATION TO:HEALTH BUDDY APPLIANCE
- K072857 — TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
- K072908 — PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
- K072959 — MS SYSTEM (DENTURE)
- K073319 — STATMATIC 31 HANDPIECE MAINTENANCE UNIT
- K073521 — MUSMATE WALKING AID
- K073531 — ACCIN PEDICLE SCREW SYSTEM
- K073554 — NEUN
- K053527 — SPECTRA HAIR REMOVAL LASER
- K063350 — DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
- K070985 — AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
- K071149 — HRI 6500, 6600 AND 6700 SERIES V2MASKS
- K071199 — BONALIVE GRANULES
- K071866 — NTRAINER SYSTEM
- K072018 — BS-200 CHEMISTRY ANALYZER, MODE BS-200
- K072093 — PRISMAFLEX SYSTEM, VERSION 3.20
- K072123 — HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
- K072270 — DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON)
- K072889 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
- K073200 — GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
- K073457 — MSTAR MPD4500
- K073651 — NEOTRACT ANCHOR SYSTEM
- K080106 — SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
- K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
- K072002 — FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55
- K072363 — NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX
- K072691 — CERVICAL MD, MODEL C10
- K072798 — VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER
- K072920 — HANDHELD BASE UNIT
- K073171 — RESUSCITATION TIMER, MODEL L770-CPR
- K073530 — ACCIN ANTERIOR CERVICAL PLATE SYSTEM
- K073539 — PROVISA CEM
- K073559 — 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
- K073563 — MODIFICATION TO PROXIS SYSTEM
- K080121 — CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER
- K080124 — VENTRI 1.1
- K070514 — ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH, BRACHIAL APPROACH, EXTRACTION KIT, PRECURVED EXTRACTIO
- K071778 — HERO VASCULAR ACCESS DEVICE
- K072252 — VEINOPLUS NEUROMUSCULAR STIMULATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.