FDA 510(k) clearances — page 512
clearances on record, most recent first.
Clearances — page 512
51,101–51,200 of 176,542- K093710 — THE MOSES APPLIANCE
- K093905 — TRILOGY 202 VENTILATOR
- K094012 — CAPNOSTREAM20 WITH MICROMEDICO2 MODULE
- K100235 — FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE
- K100336 — MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711
- K100503 — PULPDENT COPAL VARNISH WITH FLUORIDE
- K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
- K100560 — EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
- K101062 — GLIDER PTA BALLOON CATHETER
- K101215 — NUANCE
- K082044 — ACE STAPLER, MODEL F0031
- K092190 — SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
- K092507 — ZIT-Z
- K092812 — SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
- K093094 — VELA VENTILATOR
- K093268 — INTELLIVUE PATIENT MONITOR
- K093649 — AESCULAP STERILCONTAINER S
- K093978 — EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
- K100160 — ZZOMA POSITIONAL SLEEPER MODEL 001
- K100211 — PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
- K100238 — HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM
- K100406 — FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
- K100691 — OMNI V SBRT POSITIONING SYSTEM, MODEL RT-4500
- K100839 — BARIREP
- K101264 — TEMPUS IC PROFESSIONAL PATIENT MONITOR
- K092349 — CLEARVIEW EXACT II INFLUENZA A & B TEST
- K092955 — REDSENSE-HOME USE
- K093161 — ACTIPROTECT UF N95 RESPIRATOR
- K093327 — INTCO TAB ELECTRODE
- K093813 — OCCLUSIN 500 ARTIFICIAL EMBOLIZATION DEVICE
- K093863 — EPIDRUM
- K100006 — HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
- K100095 — CENTRAL VISION ANALYZER MODEL 1000
- K100182 — SALVIN DENTAL SPECIALTIES FIXATION SCREW
- K100257 — VLOC9ABSORBABLE WOUND CLOSURE DEVICE
- K100274 — MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
- K100289 — ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781
- K101078 — BL HEALTHCARE REMOTE CARE MANAGEMENT SYSTEM
- K091336 — IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
- K091812 — FRONTIER DEVICES CRANIOMAXILLOFACIAL, CRANIO CLOSURE, ORTHOGNATHIC, MANDIBLE RECONSTRUCTION AND MESH SYSTEMS
- K092476 — SPORT-ELEC BODY CONTROL SYSTEM, MODEL 4M
- K093739 — BLOOD PRESSURE MONITOR/ MODELS
- K093747 — ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS
- K093766 — VITALOGIK 6000/6500
- K094002 — SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
- K094039 — HYALO GYN
- K100056 — MEDCOM RT-VIEWER SYSTEM
- K100619 — SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
- K101067 — SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8 MODEL: 863063, 863064, 863065, 863066, 863068
- K091615 — MED CONTOUR
- K092097 — A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH
- K092467 — VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED
- K092560 — PARI SINUS
- K093862 — CAREVENT HANDHELD CPAP SYSTEM
- K093909 — BUSSE SURGICAL DRAPES IV
- K100142 — AEQUALIS REVERSED SHOULDER PROSTHESIS
- K100852 — STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000
- K100974 — SPECTRUM TURBO-JECT PICC SET
- K092302 — POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
- K094005 — FORA G31A/TD-4256A BLOOD GLUCOSE MONITORING SYSTEM AND FORA G31B/TD-4256B BLOOD GLUCOSE MONITORING SYSTEM
- K100180 — SURGIQUEST ANCHORPORT SIL KIT
- K100187 — EASYRA GLU-T REAGENT, EASYRA GLU-H REAGENT
- K100320 — SLENDERTONE SYSTEM ULTRA MODEL E70/X70
- K100412 — BIOLOX DELTA CERAMIC FEMORAL HEADS
- K100486 — POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, YELLOW COLOR
- K100508 — CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
- K100778 — DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
- K100830 — M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
- K101197 — PARIE TENE PROGRIP MESH
- K093737 — HEMOSIL F11 & FV DNA CONTROL
- K100019 — PASCAL STREAMLINE PHOTOCOAGULATOR
- K100139 — SAFE LIFE N95 RESPIRATOR AND SURGICAL MASK, MODELS B130 AND B150
- K100306 — KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
- K100325 — PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES
- K100341 — SPERMCHECK FERTILITY
- K100423 — DERMABOND NX ADHESIVE MODEL: DNX6, DNX12
- K100523 — ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA
- K100614 — HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES
- K093886 — ENGSTROM CARESTATION, ENGSTROM PRO
- DEN090005 — PRINEO SKIN CLOSURE SYSTEM
- K091797 — TSRH SPINAL SYSTEM
- K091958 — BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM
- K092033 — VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
- K092554 — BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES
- K092969 — H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F
- K093235 — RINGLOC + HYBRID ACETABULAR SYSTEM
- K093263 — STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE
- K093857 — C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
- K094064 — ILUMA VISION MODEL VERSION 2.2
- K100012 — GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A
- K100093 — VSI TORQUE DEVICE
- K100278 — QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
- K100292 — CAAS QVA 3D, CAAS QCA 3D
- K100347 — OPTIBOND SE
- K100436 — CLICKFINE PEN NEEDLE
- K100475 — AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
- K100723 — DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5
- K100733 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100915 — INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650
- K100921 — ADMIRAL XTREME PTA BALLOON DILATATION CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.