FDA 510(k) clearances — page 616
clearances on record, most recent first.
Clearances — page 616
61,501–61,600 of 176,637- K063469 — MEDICAN ALPHA
- K063485 — LOGIC LAPAROSCOPIC SCISSORS
- K063519 — DYNAMIC GAS SCAVENGING SYSTEM (DGSS)
- K063538 — ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD AND WANDS
- K052519 — SPECTRAL WEST NILE VIRUS IGM STATUS TEST
- K061814 — VASOPRESS DVT SYSTEM, MODEL VP500D
- K062271 — M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
- K062313 — SENSTOUCH HIGH RISK LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE
- K062340 — CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEM
- K062589 — SERENITY PSF (PNEUMATIC SKIN FLATTENING) SYSTEM
- K062688 — POWDER-FREE BLACK LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
- K062748 — MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD
- K062833 — POWERED EZ-IO BONE MARROW ASPIRATION SYSTEM
- K063177 — RAPID STRAND RX
- K063188 — DEL-IMS
- K063197 — 21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
- K063198 — 21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
- K063277 — MAPMATE
- K063312 — MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942
- K063342 — MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
- K063448 — EMG AC/DC SUCTION UNIT
- K063507 — SYNGO NEURO PBV CT
- K062466 — ARTHREX INTERFERENCE SCREW
- K062581 — OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
- K062592 — CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
- K062702 — ULTICARE DISPOSABLE SYRINGES AND NEEDLES
- K062749 — SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
- K063060 — BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
- K063141 — OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
- K063195 — LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE, MODELS LF5034 AND LF5044
- K063279 — NOVATION SPLINED RDD FEMORAL STEMS
- K063305 — STIMULATING BUR GUARD
- K062579 — OMNIPICC P.I.
- K062812 — DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
- K063003 — AURORA
- K063010 — REGEN BIOCEMENT
- K063288 — SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
- K063344 — CAAS QCA 3D
- K063435 — GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
- K062300 — OX-SOX, MODEL C, D, E,
- K062828 — MOUTHGUARD AND ALIGNER MATERIALS
- K063146 — ACCU-CHEK LINKASSIST
- K063299 — MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN
- K061517 — PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
- K061567 — BIOHORIZONS CERAMIC ABUTMENT
- K061608 — MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
- K061617 — FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST
- K061749 — ECLIPSE TOTAL ANKLE IMPLANT
- K061892 — PROPATCH SOFT TISSUE REPAIR MATRIX
- K061948 — PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS
- K061951 — ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL XPEEDIOR 120
- K062077 — VITROS CHEMISTRY PRODUCTS AMPH REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS
- K062094 — VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V
- K062233 — HEARTSTART MRX MONITOR/DEFIBRILLATOR
- K062270 — RADIUS SPINAL SYSTEM
- K062347 — ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
- K062467 — AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
- K062507 — MICRO-INFUSION SYSTEM
- K062515 — RETENTION FLOW OPAQUE
- K062593 — CARDIAC MARKERS CONTROL AND CALIBRATION VERIFICATION CONTROL SET
- K062637 — VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
- K062638 — TAMPAX COMPAK PEARL PLASTIC APPLICATOR SCENTED AND UNSCENTED TAMPONS
- K062684 — EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
- K062734 — ADJUST-RIGHT FIXATION DEVICES
- K062817 — PTW DAVID IMRT QC VERIFICATION SYSTEM
- K062855 — CALCIUM
- K062857 — KLS MARTIN QUICK DISC
- K062980 — ACTIVASCREW
- K062985 — IVUS ENHANCER
- K063021 — PROFILER 2
- K063138 — MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
- K063156 — MODIFICATION TO EXPEDIUM SPINE SYSTEM
- K063212 — CLEVER CHEK TD-4231 AND TD-4223 BLOOD GLUCOSE MONITORING SYSTEM
- K063246 — XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
- K063247 — XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
- K063257 — FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT
- K063273 — PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR
- K063303 — UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
- K063327 — ORTHOVIEW
- K063330 — ORTHOCON HEMASORB RESORBABLE HEMOSTATIC BONE PUTTY
- K063421 — DX-SI
- K050263 — MILLENNIUM SERIES, INCLUDING MILLENNIUM B, B+, B2 AND BU
- K060054 — ONCOBIONIC SYSTEM
- K061705 — CADWELL EASYNET NASAL PRESSURE MODULE
- K061794 — FIDIS TM THYRO, MODEL MX002
- K061983 — STIMUPLEX PEN
- K062044 — THE 5.0 X 6.0MM DENTAL IMPLANT
- K062153 — PORTABLE OXYGEN GENERATOR SYSTEM
- K062166 — ENAMEL PRO
- K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT
- K062212 — SILVER SHIELD ANTIMICROBIAL SKIN AND WOUND GEL, MODEL 3015-S
- K062413 — AESCULAP PNEUMATIC KERRISON
- K062500 — FLEXPEN NEEDLE
- K062571 — LONGPORT EPISCAN, MODEL-I-200
- K062662 — TELEMEDICINE SYSTEM MODEL VMS-01
- K062683 — ENAMEL PRO VARNISH
- K062721 — GREENTON ECOLITE IPL SYSTEM
- K062781 — MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
- K062822 — VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7500
- K062945 — BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML
Data sourced from openFDA. This site is unofficial and independent of the FDA.