FDA 510(k) clearances — page 400
clearances on record, most recent first.
Clearances — page 400
39,901–40,000 of 175,770- K130390 — COMPREHENSIVE CONVERTIBLE GLENOID
- K131207 — FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
- K131546 — AU BICARBONATE REAGENT
- K131774 — HAMILTON-G5
- K131981 — CEZANNE II INTERBODY FUSION SYSTEM
- K132010 — VIDAS C DIFFICILE GDH
- K132667 — SYNERGY ODM
- K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
- K132819 — PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
- K130110 — MEDDUSA BIPOLAR SYSTEM
- K130834 — R7
- K130857 — PRONTOSAN WOUND GEL X
- K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT
- K131186 — SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM
- K131353 — COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE
- K131362 — INMODE WMBODY DEVICE
- K131472 — APEX KNEE MODULAR TIBIA SYSTEM
- K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE
- K132142 — NERIA SOFT 90 INFUSION SET
- K132224 — UNIMED SURGICAL COATED ELECTROSURGICAL ELECTRODES
- K132362 — WECK EFX ENDO FASCIAL CLOSURE SYSTEM
- K132471 — CD HORIZON SPINAL SYSTEM
- K132589 — ANTERIOR LUMBAR PLATE SYSTEM (PRESIDIO)
- K132734 — NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS
- K132829 — QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
- K130709 — VISI MOBILE MONITORING SYSTEM
- K130940 — KYMCO EQ20C SCOOTER
- K131143 — TRELLIS COLLAGEN RIBBON
- K131201 — ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
- K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL
- K131483 — PHILIPS PIXIUM 4343RC
- K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE)
- K131749 — HEM-6221
- K131769 — CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
- K131771 — CAREGIVER PROFESSIONAL CLINICAL THERMOMETER, PRO-TF SERIES
- K132337 — ESOFLIP BALLOON DILATION CATHETER
- K133017 — ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
- K121447 — ISCHEMA VIEW RAPID
- K122800 — INNER PEACE
- K130628 — PATHFAST CK-MB-II CALIBRATORS
- K131709 — SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT
- K131820 — AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
- K131948 — MICROPLEX COIL SYSTEM (MCS)
- K132440 — XPRESS MULTI-SINUS DILATION TOOL
- K132454 — VITAHEAT PATIENT WARMING SYSTEM
- K132645 — THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES
- K132719 — STAXX IBL SYSTEM
- K132768 — S8 EXP PORTABLE DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
- K132861 — UGEO H60 DIAGNOSTIC ULTRASOUND SYSTEM
- K132863 — SMARTSITE VIALSHIELD
- K132905 — 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER
- K122536 — AMCAD-UT DETECTION MODEL 2.0
- K122557 — MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
- K130180 — CLEANSER ROOT CANAL
- K130525 — OCCLUSION PERFUSION CATHETER
- K130908 — DISPOSABLE SILICONE FOLEY CATHETER
- K130947 — FINGERTIP PULSE OXIMETER
- K131042 — LEDEX
- K131368 — NEO KNEE SYSTEM
- K131435 — ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,
- K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER
- K131583 — THERMOCHEM HT-2000
- K131617 — COLONGLIDE(R) LUBRICANT
- K131625 — ANYSCAN-S SPECT IMAGING SYSTEM
- K131673 — MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT
- K131824 — AVAFLEX VERTEBRAL BALLOON SYSTEM
- K132110 — NATUS WARMETTE BLANKET AND DUAL CABINETS
- K132141 — BEAUTIFIL BULK FLOWABLE
- K132183 — DICOM VIDEO
- K132199 — DEROYAL ELECTROSURGICAL PENCIL, ROCKER STYLE WITHOUT HOLSTER, DEROYAL ELECTROSURGICAL PENCIL, BUTTON STYLE WITHOUT HOLST
- K132361 — EVEREST SPINAL SYSTEM
- K132554 — AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5
- K132575 — PASS LP SPINAL SYSTEM
- K132642 — LOCKING PLATE SYSTEM
- K132675 — EMBOZENE MICROSPHERES
- K132760 — NAUTILUS SPINAL SYSTEM
- K132774 — PICCOLO COMPOSITE NAILING SYSTEM
- K131975 — ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
- K132600 — FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
- K132693 — BD Veritor System Flu A+B Assay
- K123711 — PATIENT MONITOR
- K130020 — ACCESS TOTAL BHCG (5TH IS)
- K131251 — TRINITY ELE
- K131458 — MPACT DM LINER CONVERTER
- K130573 — TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
- K131396 — WIRED MOUTH PROTECTOR (WMP)
- K131845 — ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
- K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM
- K132097 — BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
- K132266 — SHASER HRS2 RX HAIR REMOVAL SYSTEM
- K122219 — THEYFIT MALE CONDOM
- K123822 — KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET
- K130560 — MASTERTORQUE LUX 8900 L
- K130663 — BESTFIT2 NASAL MASK
- K130874 — STRYKER NAV3I PLATFORM
- K131206 — COOK CERVICAL RIPENING BALLOON
- K131385 — EASY-GRAFT
- K131559 — MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDES
- K131618 — LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST
- K131633 — ARTHREX UNIVERS APEX
Data sourced from openFDA. This site is unofficial and independent of the FDA.