FDA 510(k) clearances — page 530
clearances on record, most recent first.
Clearances — page 530
52,901–53,000 of 175,825- K091026 — TDS ABUTMENT FOR NOBEL BIOCARE REPLACE
- K091035 — FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
- K091291 — XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD
- K091546 — NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230
- K091673 — GE LIGHTSPEED ACT FP16
- K083520 — INTELEPACS, MODEL VERSION 3.X.X
- K083690 — FEMVUE(TM) CATHETER SYSTEM
- K083895 — CODMAN ISOCOOL BIPOLAR FORCEPS
- K090198 — JIAJIAN SELF-ADHESIVE ELECTRODE
- K090375 — ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
- K090393 — ARTHROCARE SYSTEM 15000 CONTOLLER, MODEL 72202149, ARTHROCARE ARTHROWANDS, MODEL 72202139,72202141, 72202143, 72202144
- K090404 — FORE V10 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4244, FOREA V12 BLODO GLUCOSE MONITORING SYSTEM, MODEL TD-4247
- K090417 — AXXENT FLEXISHIELD MINI
- K090462 — BRILLIANCE DUAL ENERGY OPTION
- K090668 — VISION TOOLS
- K091055 — RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
- K091056 — RHYTHMLINK DISPOSABLE MONOPOLAR EMG NEEDLE, MODEL TFDN26032252R
- K091209 — PORTALVISION ADVANCED IMAGING
- K091427 — VINYL POWDERED EXAMINATION GLOVE
- K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM
- K080469 — VIDAS CA 15-3 ASSAY
- K083580 — ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
- K083601 — LAMBDA LIGHT CHAINS
- K090431 — DEXIS SOFTWARE
- K090835 — CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR
- K090891 — MICROPLEX COIL SYSTEM-COSMOS
- K091032 — CERNER PROVISION WORKSTATION (VERSION 2.5)
- K091593 — ANGIO JET ULTRA DVX AND XPEEDIOR THROMBECTOMY SETS
- K091636 — OSTENE CT, AOC CT, OSTEOTENE, CERETENE
- K082340 — ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
- K082843 — MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
- K083644 — MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
- K083753 — SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU
- K090099 — DSS STABILIZATION SYSTEM
- K090621 — FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
- K090696 — NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM
- K090962 — CYBER SURGICAL LASER FAMILY INCLUDING: CYBER TM, CYBER GREEN, CYBER GREEN TM
- K090987 — VASCUTEK BRANCHED GELWEAVE
- K091038 — AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
- K091504 — MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
- K091509 — JETSTREAM G2 NXT SYSTEM, MODEL PV20300
- K091551 — VARI-LASE PLATINUM BRIGHT TIP LASER FIBER
- K091680 — DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
- K080941 — BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
- K083305 — POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
- K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS AVENT ANIMAL STAGE 2 AND 3 TEETHER,
- K090306 — ARAGON SURGICAL RF SYSTEM L2 INSTRUMENT
- K090307 — DDI ULTRASONIC NEBULIZER SYSTEM
- K090347 — CAMLOG ABUTMENTS PS
- K090476 — SYNTEC ORTHODONTIC MINI SCREW
- K090745 — ARTIS ZEE / ZEEGOS WITH SW VC14
- K090786 — KENS INTERNAL FIXATION SYSTEM
- K090939 — ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190
- K090958 — INOMAX DS (DELIVERY SYSTEM)
- K090977 — PIGGYBACK WIRE CONVERTER
- K091096 — NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100
- K091126 — VITEK 2 GRAM POSITIVE DAPTOMYCIN
- K091449 — DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
- K091478 — TREVAIR CHAIR
- K091492 — MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM
- K091518 — CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM
- K091602 — MUCHECK V8
- K091669 — OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III
- K082110 — DUAL SYRINGE HOLDER
- K082910 — CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES
- K090180 — TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
- K090241 — SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
- K090422 — LUCAS 2
- K090704 — MULTILINK IMPLANT
- K090720 — COCHLEAR BAHA BP100
- K090763 — RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
- K090837 — STRATAPULSE TS AND STRATAPULSE
- K090843 — AMARIS GINGIVA OPAQUER
- K090848 — PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM
- K091106 — EQUIA
- K091132 — 4D INTEGRATED TREATMENT CONSOLE
- K091245 — COSTORSOL
- K091466 — 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
- K091503 — MAGNUM MP FIXATION DEVICE
- K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES
- K081150 — RAPIDAN OPTIMA EARLY PREGNANCY TEST AND TOYO PREGNANCY TEST
- K081720 — PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
- K082196 — STATIC VESSEL ANALYZER
- K082879 — EZVUE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
- K082880 — EZVUE (OCUFILCON D) 1-DAY SOFT (HYDROPHILIC)CONTACT LENS
- K082883 — EZVIEW (POLYMACON) SOFT (HYDROPHILLIC) CONTACT LENS FOR DAILY WEAR
- K083016 — ACTHYDERM
- K083144 — ACUMED CLAVICLE SCREW SYSTEM
- K090721 — CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
- K091161 — REJUVENATE MONOLITHIC SIZE 4 HIP STEM
- K091581 — SUPRA 577.Y LASER
- K081259 — DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
- K090289 — CLAVICLE PLATING SYSTEM
- K090468 — HAMILTON-C2
- K090706 — ONCENTRA SIMULATION 2.3
- K091103 — GUIDESHOT OPTION FOR CXR4 AND ECLOS CT SYSTEMS
- K091484 — NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
- K091545 — DIGITAL RADIOGRAPHY CXDI-60C
- K082367 — INFANT SLEEP BEANIE
- K082505 — KLS MARTIN ELECTROSURGICAL INSTRUMENTS
Data sourced from openFDA. This site is unofficial and independent of the FDA.