FDA 510(k) clearances — page 710
clearances on record, most recent first.
Clearances — page 710
70,901–71,000 of 176,637- K033853 — MODIFICATION TO V-CATH POLY PICC
- K033936 — BARD ELIMINATOR PET BALLOON DILATORS
- K023506 — SURGICAL MEDICAL DEVICE CAUTERY
- K032796 — IBL C3D-CIC EIA TEST
- K032966 — THE ANSWER SCREW SUPPLEMENTATION SYSTEM
- K033289 — MODIFICATION TO JET-X HA COATED HALF PINS
- K033293 — MED-LOGICS, MODEL ML7090
- K033312 — EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
- K033323 — D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
- K033556 — SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
- K033569 — FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATH
- K033850 — MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
- K031147 — OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
- K032332 — ROCHE ONLINE TDM QUINIDINE
- K032334 — ROCHE ONLINE TDM LIDOCAINE
- K032361 — ENDOPURE ROOT CANAL CLEANSER
- K033155 — BIOCENTREX CARDIAC PANEL
- K033286 — ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
- K033391 — MEDICAL MAGGOTS
- K033414 — ACL TOP MODEL, TOP
- K033525 — DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
- K033742 — BOSTON SCIENTIFIC V-18 CONTROL WIRE
- K033929 — MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K032051 — BATTERY PACK, RECHARGEABLE, MODELS MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P
- K032585 — TRANSVAGINAL ULTRASOUND PROBE HOLDER SYSTEM
- K032710 — CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT
- K032886 — DIAMOND SETUP 2000
- K033215 — PREPAIR
- K033357 — ACQSIM-MULTISLICE-CT, MODEL 453567042271
- K033372 — SAPPHIRE DETACHABLE FIBERED COIL SYSTEM, HELIX FIBERED, CYCLONE, MULTIPLE MODELS
- K033377 — FUJI MEDICAL DRY LASER IMAGERS, MODELS DRYPIX 7000, DRYPIX 5000 AND FM-DP L
- K033490 — SPIRIT 5000 CARDIAC COIL
- K033830 — OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000
- K031715 — ARIOL HER-2/NEU IHC
- K031962 — NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
- K032126 — PROMOS SHOULDER
- K032822 — ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
- K033338 — PINNACLE REVISION SYSTEM
- K033539 — DISPOSAL POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, GREEN COLOR
- K033643 — CO2 CALIBRATOR/DILUENT
- K033683 — SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
- K033817 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DA1-2, IR1DE1-2
- K033818 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODELS IR1DC1/V971, IR1DG1/SKU4289, IR1DH1/SKU4290
- K033837 — STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM
- K033845 — PRECISION XCEED DIABETES MONITORING SYSTEM
- K033987 — D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
- K034003 — HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
- K034013 — REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001
- K031936 — OSTEOMED ORTHODONTIC SCREW SYSTEM
- K031995 — COMPREHENSIVE NEUROMUSCULAR PROFILER
- K032003 — PREMIER PLUS
- K032031 — SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K033268 — SEA-BAND
- K033413 — SPINEASSIST DEVICE
- K033449 — PRO-DENTEC DOUBLE-PRO PROPHYLAXIS PASTE WITH FLUOIDE FAMILY OF DEVICES
- K033469 — GENESIS VERTICAL PLATFORM LIFT
- K033475 — WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES
- K033535 — LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES
- K033547 — VNUS VESSEL AND TISSUE COAGULATION SYSTEM
- K033660 — STORZ RANEY SCALP CLIP, MODEL 1-20-004-05
- K033922 — MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
- K033937 — ELECSYS PRECICONTROL MULTIANALYTE
- K033514 — CODA CX1 MOTION ANALYSIS SYSTEM
- K033659 — VARIAN, INC. ONTRAK TESTCUP AND ONTRAK TESTSTIK
- K033433 — NOVA GLUCOSE CONTROL SOLUTIONS
- K033775 — HEMOSIL LIQUID ANTITHROMBIN XL
- K033834 — OMNILINK .018 BILIARY STENT SYSTEM
- K032554 — GEN-PROBE APTIMA COMBO 2 ASSAY
- K033242 — KNEE INTERPOSITIONAL MINI-REPAIR SYSTEM (KIMRS)
- K033636 — AMS LARGE PORE POLYPROPYLENE MESH
- K033671 — GORE BIOABSORBABLE MESH
- K033804 — BIOANCHOR WITH DISPOSABLE DRIVER
- K032127 — HEMEDEX FIXATION DEVICE
- K033147 — CLEARTOOTH DIGITAL X-RAY SYSTEM
- K033250 — EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR
- K033256 — ATHENA PELVIC MUSCLE TRAINER II
- K033317 — SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
- K033339 — ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY
- K033356 — VERASOFT ES
- K033412 — MEDICLUNG, RELEASE 1
- K033665 — VENUS FLOW
- K033754 — TRACER METRO SMART WIRE GUIDE
- K033778 — MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
- K033781 — BEBIG ISOSEED I-125
- K033794 — ULTICARE DISPOSABLE SYRINGE 3 ML/CC
- K033836 — HYDROCOIL EMBOLIC SYSTEM (HES)
- K033874 — MYOLIGHT
- K033916 — GRI-BAG, GRI-BAG AP
- K033038 — GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688
- K033478 — VACUETTE QUICKSHIELD SAFETY TUBE HOLDER
- K033829 — BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
- K031869 — SISS INC. (D.B.A. MEDISISS) REPROCESSED ELECTROSURGICAL INSTRUMENTS AND ACCESSORIES
- K032194 — TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
- K032571 — IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY IGA ELISA
- K033001 — APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
- K033371 — VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
- K033487 — STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI
- K033906 — PORTASCAN BLADDER SCANNER, MODEL PA00146
- K030360 — RANDOX EVIDENCE
- K031267 — STERICHEK BICARB PH REAGENT STRIPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.