FDA 510(k) clearances — page 622
clearances on record, most recent first.
Clearances — page 622
62,101–62,200 of 176,637- K062606 — CD HORIZON SPINAL SYSTEM
- K062701 — QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR
- K060763 — STRYKER INJECTABLE CEMENT
- K060917 — KENSEY NASH BONE VOID FILLER
- K060919 — ACTICAL
- K061155 — VISTA P VERTEBRAL BODY REPLACEMENT SYSTEM
- K061311 — ALLOGRAN-R
- K061528 — SELFCHECK GLUCO
- K061598 — HEMOSIL HOMOCYSTEINE AND CONTROLS
- K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH
- K061979 — MODIFICATION TO MYALLERGY TEST
- K062049 — EVIS EXERA II 180 SYSTEM
- K062072 — PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
- K062119 — HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
- K062163 — MIMVIEWER
- K062164 — RESOLUTIONMD, VERSION 1.3
- K062204 — ARCHITECT CORTISOL ASSAY
- K062334 — DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
- K062531 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
- K062618 — TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
- K062673 — MODIFICATION TO SYNGO INSPACE 4D
- K061473 — SURGI-WRAP MAST BIORESORBABLE SHEET
- K061494 — DERMADAPT WOUND DRESSING
- K061507 — SONICWELD RX ENDOBROW FIXATION
- K061787 — MAXFORCE TTS SINGLE-USE BALLOON DILATOR
- K061910 — SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS)
- K062238 — TYTAN BLOOD PRESSURE CUFF
- K062402 — EASYSTAND EVOLV
- K062423 — OMNIGUIDE BEAMPATH LASER BEAM DELIVERY SYSTEM
- K062452 — KIT MENDEC SPINE AND DELIVERY SYSTEM
- K062457 — INFUSOR SMALL VOLUME ELASTOMERIC INFUSION DEVICES
- K062639 — MODIFICATION TO HEXAPOD RT COUCH TOP
- K062650 — EP NAVIGATOR SOFTWARE
- K061023 — THERMOSUIT SYSTEM
- K061871 — LEICA MODEL FL800
- K062086 — NAVIVISION
- K062093 — AVEA VENTILATOR
- K062172 — FETCH ASPIRATION CATHETER
- K062275 — RINSPIRATION CATHETER SYSTEM, MODELS 50135, 550135, P7065, P70135
- K062283 — THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS
- K062448 — LYRA ACUPUNCTURE NEEDLES
- K062594 — MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
- K062611 — IGUIDE SYSTEM
- K053254 — INFANT HEEL WARMER BY INTCO
- K061339 — HIERSPEC SPECULUM
- K061573 — TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT
- K061763 — ARC SURGICAL BIOTRAK SCREW
- K061790 — PVA PLUS, MAXISTAT PVA, MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
- K061813 — MANTIS SPINAL SYSTEM
- K061945 — VITEK 2 AST-YS FLUCONAZOLE
- K061990 — DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
- K061992 — EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
- K062235 — EASY CHECK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM; CLEVER CHECK TD-4222, TD-4225, TD-4226 BLOOD GLUCOSE MONITORING SYST
- K062278 — SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847
- K062488 — IQ-SYSTEM PACS SYSTEM
- K062585 — MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN
- K062596 — MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID
- K060644 — AHMED GLAUCOMA VALVE, MODEL M4
- K060953 — OCCULTECH FECAL OCCULT BLOOD RAPID TEST
- K061532 — GENTLE COLON (REVISION 2.0)
- K061658 — SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L
- K061860 — CLEARFIL MAJESTY ESTHETIC
- K061972 — CONNECT IMAGING PACS
- K062390 — CRYSTALVIEW R200
- K062578 — DIGI-LITE TCD DEVICE
- K062655 — POWDERED (WHITE) VINYL PATIENT EXAMINATION GLOVES
- K060681 — MEDTRONIC PS MEDICAL STRATA TYPE VALUE
- K060770 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV IGM-REAGENT PACK, CALIBRATOR, AND CONTROLS
- K060944 — NUTRISAFE 2
- K061190 — ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953
- K061502 — MEDIC4ALL TELEMEDICINE SYSTEM VMS-01
- K061557 — FUSION
- K061659 — POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K061662 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K061685 — PULSERA
- K061690 — SURGICAL HEADLIGHT
- K061741 — MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM
- K061744 — COCHLEA-SCAN / COCHLEA-SCAN PLUS
- K061780 — TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
- K061864 — DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
- K061877 — WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
- K061974 — GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
- K062092 — PREVU POINT OF CARE SKIN STEROL TEST
- K062216 — PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
- K062406 — AESCULAP NEURO PATTIES
- K062417 — XPLORER 1100
- K062425 — LIFECATH S PICC AND MIDLINE CATHETER
- K062458 — ETHMOID SINUS SPACER
- K062608 — 29G AND 30G K-PACK II NEEDLE
- K052475 — VYGON NUTRILINE AND NUTRILINE TWINFLOW CATHETERS
- K060678 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HAV TOTAL REAGENT PACK,CALIBRATOR,CONTROLS
- K060762 — AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
- K061225 — STRYKER DISPOSABLE LAPAROSCOPIC SCISSORS
- K061577 — OVALTWIST PEDICLE SCREW SYSTEM
- K061695 — LED PROLUX 770
- K061824 — TORNIER CEMENT RESTRICTOR
- K061932 — BERNOULLI MANAGEMENT SYSTEM (MS) SOFTWARE
- K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
- K062162 — DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)
- K062182 — DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520
Data sourced from openFDA. This site is unofficial and independent of the FDA.