FDA 510(k) clearances — page 677
clearances on record, most recent first.
Clearances — page 677
67,601–67,700 of 175,825- K042656 — INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
- K041698 — AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
- K041858 — ACUMED ANATOMIC RADIAL HEAD SYSTEM
- K042137 — PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS
- K042232 — NP-2600 SERIES HARDCOPY PRINTERS
- K042397 — SCANX 14
- K042417 — ZOLL M SERIES ETC02 LOFLO OPTION
- K042535 — ADVENTURE A10
- K042651 — FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K031238 — VARICES NEEDLE
- K033589 — BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR
- K040189 — ENDOMETRIAL SAMPLING SYRINGE
- K040334 — NAVIGUS PASSIVE PROBE, MODEL NP-1000
- K040601 — EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
- K041122 — PRECISION LIQUID OXYGEN SYSTEM
- K041919 — PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606
- K042236 — G-SCAN
- K042243 — MICROALBUMIN MULTI-CALIBRATOR SET
- K042258 — BP-SPECT V1.O
- K042368 — PRACTIX CONVENIO
- K042372 — HDS INTRA-ORAL IMAGING SYSTEM
- K042540 — PHILIPS IU22 ULTRASOUND SYSTEM
- K040311 — SHIAN JIA MEEI DIGATAL PWN TENS, MODEL YW-6000/UC-332/UC-330/ST-331
- K040849 — MENTAMOVE
- K040889 — EXACTECH OPTETRAK UNICONDYLAR KNEE
- K041062 — INTRAUTERINE VENOGRAM NEEDLE SET
- K041208 — POWERED WHEELCHAIR, MODEL B-500
- K041210 — POWERED WHEELCHAIR, MODEL B-600
- K041211 — POWERED WHEELCHAIR, MODEL C-1000
- K041389 — SYNTHES CONTOURED SYNMESH SPACER
- K041714 — E-PAIN CARE
- K041808 — ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
- K041962 — XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
- K042037 — M2A MAGNUM SYSTEM
- K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
- K042402 — MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
- K042467 — LSO PET/CT HIREZ 64
- K042503 — KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
- K042518 — ZILVER 518 BILIARY STENT
- K042525 — CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
- K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- K041139 — ERCHONIA EML LASER
- K041651 — STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
- K041767 — COOLCUBE COOLPEN
- K042056 — AZ ULTRASONIC SYSTEM
- K042059 — SHOULDER FIXATION SYSTEM
- K042062 — PERIPHERAL VASCULAR SHEATH TUNNELER STERILIZATION CASSETTE
- K042065 — WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM
- K042226 — SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
- K042267 — INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS 3001N95-S, 3002N95-M, 3003N95-L, AND 3004N95-LP
- K042364 — PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES
- K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
- K042464 — V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
- K042488 — PERIFIX CATHETER AND CONTIPLEX CATHETER
- K042490 — ELECSYS FOLATE II CALSET II
- K042575 — AMPLIFE DIGITAL CLINICAL THERMOMETER
- K031611 — P4-FITNESS
- K040658 — BARDEX I.C. LATEX FOLEY CATHETER
- K041435 — THE STRIPPER PGD
- K041739 — EDWARDS E360 SURGICAL ABLATION DEVICE
- K041830 — MAGELLAN RATIO DISPENSER KIT
- K041866 — ABBOTT AXSYM TESTOSTERONE MICROPARTICLE ENZYME IMMUNOASSAY (MEIA)
- K042015 — ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
- K042033 — HOVEROUND POWER WHEELCHAIR, MODEL HD700
- K042277 — SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM
- K042361 — DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D
- K042474 — ARION
- K042569 — 8600 VITAL SIGNS MONITOR
- K040549 — COSMED PONY FX
- K040921 — COOLTOUCH, MODEL NS 160
- K041079 — GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103
- K041560 — FLO-ASSISTANT
- K041587 — LIGASURE PRECISE MODEL #LS1200/LIGASURE 5MM LAPAROSCOPIC SEALER DIVIDER MODEL # LS1500
- K041724 — COMPASS M10 SYSTEM
- K041783 — POLAR WAND
- K041835 — ENDOTINE MIDFACE B 4.5 DEVICE
- K041868 — VALUPEN,PROFILE
- K041905 — HEMOSIL CALIBRATION PLASMA
- K042141 — POLYGLYTONE 6211 SYNTHETIC ABSORBABLE SUTURE
- K042233 — PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
- K041914 — PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER
- K042303 — VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
- K042334 — ALLURA 3D-CA, RELEASE 1
- K042507 — UBIPACS
- K041002 — FIDIS CELIAC
- K041129 — PERSONAL LUBRICATING GEL
- K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
- K041792 — FRESENIUS STAYSAFE PATIENT CONNECTORS, MODEL 050-87211
- K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
- K041925 — ST360 SPINAL FIXATION SYSTEM
- K042011 — POWER SCOOTER, MODEL TL0821
- K042012 — TEH LIN POWER SCOOTER, MODEL TL-822
- K042019 — HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
- K042158 — KODAK MEDICAL IMAGER 300
- K042159 — KODAK COLOR MEDICAL IMAGER 1000
- K042198 — PS MEDICAL NEUROSURGICAL IMPLANTS
- K042203 — LEONARDO SYNGO CARDIOLOGY WORKSTATION
- K042312 — JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE
- K042317 — CERVICAL PLATE
Data sourced from openFDA. This site is unofficial and independent of the FDA.