FDA 510(k) clearances — page 504
clearances on record, most recent first.
Clearances — page 504
50,301–50,400 of 175,770- K094046 — LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
- K094054 — MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
- K100010 — HDL CHOLESTEROL (HDLX) ASSAY
- K100047 — SUREFIT DUAL DISPERSIVE ELECTRODE
- K100271 — VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES
- K100294 — SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
- K100521 — COMFYSLEEVE 1-75 AND LYMPHAPOD SLEEVES, FOR USE WITH LP OPTIMAL AND PLUS
- K100704 — ACCU-CHEK FLEXLINK PLUS INFUSION SET, ACCU-CHECK LINKASSIST PLUS INSERTION DEVICE
- K100788 — COCR RODS
- K090633 — LENSAR LASER SYSTEM
- K092164 — TRANSCRANIAL AND VASCULAR DOPPLER DIAGNOTIC ULTRASOUND TRANSDUCERS, MODEL EMS-9UA
- K093123 — BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
- K093716 — BABI PLUS INFANT NASAL CANNULA SYSTEM
- K100089 — SYNTHES T-PAL SPACER
- K100265 — DIAMOND ANTERIOR CERVICAL PLATE SYSTEM
- K100353 — SPINEWAND SURGICAL DEVICE
- K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
- K100697 — POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- K100897 — LEGION POROUS + HA TIBIAL BASEPLATES
- K101056 — VARIAX ELBOW SYSTEM
- K091255 — MINXRAY, MODEL: BPD60
- K092116 — EASYCELL CELL LOCATOR
- K092219 — NAVIGATOR CLINICAL GUIDENCE SYSTEM
- K092586 — MALE LATEX CONDOM (STRAIGHT SIDE OR CONTOURED OR FLARED IN SHAPE, EITHER TEXTURED OR NON-TEXTURED , LUBRICATED OR NON-LU
- K092789 — VIRTUOSAPH PLUS ENDOSCOPIC VESSEL HARVESTING SYSTEM
- K093087 — BWF-5 MEDICAL LASER SERIES
- K093114 — THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
- K093590 — PLANMECA PROMAX 3D MAX
- 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.