FDA 510(k) clearances — page 377
clearances on record, most recent first.
Clearances — page 377
37,601–37,700 of 175,770- K140379 — MEGA BIG BOY CONDOM
- K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
- K140411 — ALTERA SPACER
- K140843 — DESARA BLUE OV, DESARA BLUE SS
- K141148 — EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
- K141234 — ODISSEY TISSUE OXIMETER
- K141406 — IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
- K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK
- K124021 — ARKRAY GLUCOCARD 01 BLOOD GLUCOSE MONITORING SYSTEM AND RELION CONFIRM BLOOD GLUCOSE MONITORING SYSTEM
- K132354 — POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE
- K132491 — MUELLER HINTON AGAR
- K132551 — ZF 720
- K133189 — DUAL SHOT ALPHA 7
- K133575 — SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM
- K140243 — SHUNTONG
- K140674 — EXACTECH TAPERED WEDGE FEMORAL STEM
- K140751 — MIROCAM CAPSULE ENDOSCOPE SYSTEM
- K140833 — ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
- K141045 — MBD PLATE SYSTEM
- K141374 — BICARBONATE CALIBRATOR
- K141395 — DELTA TT ACETABULAR SYSTEM
- K141447 — PRECICE TRAUMA NAIL SYSTEM
- K130755 — HICUT HIGHSPEED INSTRUMENT
- K132195 — EUROIMMUN ANTI-PLA2R ELISA (IGG)
- K133260 — MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM
- K133632 — PERICAN ULTRA
- K133843 — SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
- K133901 — PARI-PATH SURGICAL NAVIGATION SYSTEM
- K140132 — BIODENTINE
- K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
- K140542 — NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER
- K140650 — HIVOX ELECTRIC STIMULATOR OTC TENS
- K140701 — NOVOHIP BIPOLAR HEAD/NOVOHIP VITAMIN E LINER/ BONE SCREWS/ HOLE PLUG
- K140788 — P-STIM
- K140819 — SURGICAL NAVIGATION ADVANCED PLATFORM
- K140823 — PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER
- K141179 — A&D MEDICAL UB-543 DIGITAL BLOOD PRESSURE MONITOR
- K141413 — CRC PC WITH SMART CHAMBER
- K141428 — MDMC-12133
- K141578 — DEVON CIRONA 6200 DVT
- DEN130034 — REWALK
- K133194 — DIAMOND RATTLESNAKE SYSTEM
- K133465 — CONSURE STOOL MANAGEMENT SYSTEM
- K133579 — MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
- K133961 — SURESIGNS VS3, SURESIGNS VS4
- K140053 — KANGLI PEDICLE SCREW SPINAL SYSTEM
- K140435 — MEDLEY GOLD
- K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- K140659 — COROENT THORACOLUMBAR IMPLANTS
- K140803 — LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
- K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K141346 — SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
- K141376 — INERTIA PEDICLE SCREW SYSTEM, HONOUR SPACER SYSTEM, FACET FIXX, STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS
- K141397 — SURE-LOK C EXTENDED TAB PEDICLE SCREW SYSTEM
- K141454 — SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
- K132115 — ABSOLUTE DENTIN 2
- K132180 — IDEAL LIFE GLUCO-MANAGER BLOOD GLUCOSE MONITORING SYSTEM
- K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSING
- K133327 — SATURNO(TM) OVERDENTURE IMPLANT SYSTEM
- K133848 — RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK
- K140188 — MASIMO ROOT MONITORING SYSTEM
- K140336 — OPTIMUS FUSION: SLT, YAG AND YAG/SLT
- K140629 — VENUS SWAN(MP)2
- K140801 — VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
- K141104 — TRUKLEAR BRACKET
- K133083 — DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
- K133105 — BREEZE NEBULIZER (NBR-10X)
- K133816 — IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
- K140660 — MOBIUS3D
- K130265 — CONTOUR NEXT EZ BLOOD GLUCOSE METER
- K131416 — NOVOPRESS
- K133193 — RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
- K140809 — CLIQ DV-300 ASPIRATOR
- K141072 — SUPOLENE
- K141073 — LIQUICHEK TUMOR MARKER CONTROL
- K141232 — APTUS ULNA SHORTENING 2.5
- K123149 — SERVO-I VENTILATOR SYSTEM
- K132489 — INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
- K132697 — ENCOMPASS 10/12 HIP STEM
- K133011 — DIAPHRAGMATIC HERNIA GRAFT
- K133062 — DISCOVERY SYSTEM
- K133147 — BRACCO INJEENERING TRANSFER SET
- K133646 — ADMIRE
- K133799 — THERMEDX FLUID MANAGMENT SYSTEM
- K133886 — PERSEUS A500
- K134032 — ULTHERA SYSTEM
- K140083 — VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
- K140155 — SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
- K140278 — SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
- K140610 — NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
- K140679 — SUREFLEX LITHOTRIPSY LASER FIBERS
- K140711 — COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
- K141121 — AXSOS 3 TI LOCKING PLATE SYSTEM
- K141149 — VITEK 2 AST GP CEFTAROLINE
- K141199 — QUENTRY DOSE REVIEW
- K141204 — VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM
- K141329 — RADSPA
- K141356 — ECHO TIP ULTRA FIDUCIAL NEEDLE
- K130694 — JR IMPLANT SYSTEM
- K132869 — SILDENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.