FDA 510(k) clearances — page 778
clearances on record, most recent first.
Clearances — page 778
77,701–77,800 of 176,637- K014107 — ENDIUS CERVICAL PLATE SYSTEM
- K014185 — AOS CANNULATED BONE SCREW SYSTEM
- K014288 — DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
- K020353 — OMNIA X/XS ULTRASOUND SYSTEM
- K994055 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K010452 — BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
- K011835 — COBE REVOLUTION
- K011974 — SENSAID
- K012003 — DRG REACTION CHAMBER/SAFETY TIP
- K012368 — AEROPEP
- K012490 — ORION DIGITAL IMAGING SYSTEM
- K012675 — REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS
- K012976 — TWIN PLUS
- K013872 — RUSCH MEMORY BAG
- K013887 — BACFIX SPINAL FIXATION SYSTEM
- K013904 — BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
- K013908 — WATERLASE MILLENNIUM
- K014261 — ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
- K020083 — TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
- K020164 — E-SCAN XQ
- K020232 — HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
- K020295 — NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0
- K020301 — MODIFICATION TO VISTA STEREOSCOPE SYSTEM
- K020362 — P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
- K010694 — INCLUDER CLAMP
- K011106 — STONELITH, MODEL V5
- K011275 — PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY
- K012052 — MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
- K012277 — PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE
- K012467 — SOLAR 8000M SYSTEM
- K012597 — STERILMED REPROCESSED COMPRESSION SLEEVES
- K012811 — BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS 10-MBB,10-MBB-B,10-MPB,10-MPB-B
- K013223 — PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM (PVOCS)
- K013284 — LUMEND FRONTRUNNER CTO CORONARY CATHETER
- K013479 — COMPLETE BRAND MULTI-PURPOSE SOLUTION
- K013635 — TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)
- K013722 — MODIFICATION TO: EUB-8500 DIAGNOSTIC ULTRASOUND SCANNER
- K013747 — TEKNO-MEDICAL OBSTETRICAL FORCEPS
- K013748 — CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
- K013749 — ENDOANCHOR AND OPENANCHOR
- K013760 — DC-3300 LASER DIODE PHOTOCOAGULATOR
- K013812 — SPIROLAB II, MODEL 29
- K013944 — JOSTRA DUAL STAGE VENOUS RETURN CANNULAE
- K014048 — CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS
- K014301 — MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
- K020009 — BRACE EZE
- K020052 — SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K020090 — MODIFICATION TO TRANSSEPTAL INTRODUCER SET
- K020138 — STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
- K020170 — KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
- K020281 — MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
- K020283 — BACK-UP MEIER STEERABLE GUIDEWIRE
- K012562 — MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
- K012938 — SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS
- K013307 — OMEGATRAC, MODEL Z105
- K013755 — CONCERT RADIOPAQUE BONE CEMENT
- K013785 — UROVYSION BLADDER CANCER RECURRENCE KIT
- K013806 — SYNTHES METALLIC SPIKED WASHERS
- K013864 — MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60
- K014015 — OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K014028 — CARESIDE APTT
- K014032 — OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K014038 — PYLORITEK VP TEST KIT 5140VP
- K014120 — TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)
- K014160 — PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)
- K020075 — MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
- K020088 — MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM
- K020096 — ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
- K020264 — REPICCI II UNICONDYLAR KNEE SYSTEM
- K020284 — BIOTECH MANUAL WHEELCHAIR A2000 SUPER MOTIVE WHEELCHAIR
- K002604 — CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
- K012589 — FAST SET PUTTY
- K013732 — GELZONE
- K013778 — PEACE OF MIND HOME DRUG TEST
- K013809 — D.SIGN 59
- K013889 — ENDOSCOPIC MULTI-FIRE CLIP APPLIER
- K013929 — HELIOMOLAR HB TRANSLUCENT SHADES
- K014063 — TASK FORCE MONITOR 3040
- K014144 — EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804
- K020107 — SMARTEPIL
- K002102 — GENTLE COLONICS IRRIGATION SYSTEM
- K010175 — MICROLIGHT 830 LASER SYSTEM
- K011540 — VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
- K012439 — DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM
- K012601 — CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH
- K012606 — CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE
- K012612 — CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE
- K012616 — CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR
- K012621 — CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT
- K013006 — OVUS CAPLESS SAFETY NEEDLE
- K013717 — BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY
- K013723 — MODIFICATION TO: EUB-6500 DIAGNOSTIC ULTRASOUND SCANNER
- K013730 — ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES
- K013751 — HANDHELD GAMMA FINDER (HGF)
- K013781 — RIDIDFIX 2.7MM BTB CROSS PIN KIT
- K013854 — MARK 5000 QUADRATURE SHOULDER COIL
- K013914 — POWDERFREE LATEX SURGEON'S GLOVES
- K014169 — WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
- K014187 — AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM
- K020048 — MODIFICATION TO GEO STRUCTURE
Data sourced from openFDA. This site is unofficial and independent of the FDA.