FDA 510(k) clearances — page 580
clearances on record, most recent first.
Clearances — page 580
57,901–58,000 of 175,825- K071875 — V-CATH POLY PICC
- K072019 — AKITA2 APIXNEB
- K072082 — GUMEASE DENTAL MOUTHPIECE
- K072336 — REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
- K072580 — JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23
- K072666 — BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM
- K072794 — IMMULITE 2500 OM-MA, MODEL L5KOP
- K072868 — ACCOLADE II LASER
- K070643 — PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35
- K070874 — ARTHRO KINETICS VESALIUS MR GENERATOR, MODELS 2004-2006; ACCESSORIES FOR MR GENERATOR
- K071051 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES
- K071576 — TEXTRONICS ECG ELECTRODE
- K072134 — SCHICK COMPUTED ORAL RADIOLOGY SYSTEM
- K072313 — AMPLATZER TORQVUE DELIVERY SYSTEM
- K072532 — TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M
- K072681 — BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE
- K072848 — ACTIVASCREW
- K072919 — VENDYS, MODEL 6000 B B/C
- K070669 — IOL INJECTOR SET
- K070799 — MODULARIS VARIOSTAR
- K070984 — THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS
- K071416 — PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
- K071955 — WIM-PC, MODEL 1010
- K072059 — GRIPPER MICRO NEEDLE
- K072215 — TITANIUM POWERPORT ISP IMPLANTED PORT
- K072289 — SPINEFRONTIER DORADO VBR
- K072436 — MEGA SPINE SYSTEM
- K072641 — DIGITAL ELECTRONIC THERMOMETER, MODEL: FDTH-V0-1 THRU 4.
- K072693 — CSNP-001A NEURO PACKAGE
- K072998 — IDEAL SOFTWARE OPTION FOR GE MR SCANNERS
- K071330 — GALTSTICK INTRODUCER SYSTEM
- K071545 — Z-800 VOLUMETRIC INFUSION PUMP
- K072076 — CYTOPLAST PTFE SUTURE
- K072130 — PTFE PEEL AWAY MICROINTRODUCER
- K072358 — BIOPLEX VASCULITIS KIT
- K072404 — ERBE ERBEJET 2 SYSTEM
- K072569 — METOXIT CAM-BLANKS
- K072620 — GAME READY CLASSIC SYSTEM, MODEL 550550
- K072711 — COMFORT POWERED WHEELCHAIR, LY-EB 206
- K072712 — COMFORT ELECTRIC SCOOTER, LY-EW408
- K072787 — GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
- K072909 — 1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL
- K072935 — SPEEDER 1.5T WRIST ARRAY COIL
- K072990 — GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
- K070315 — LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8
- K072097 — BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
- K072499 — NOVOFLO CATHETER LT
- K072557 — FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
- K072567 — SYMBIA-E, MODEL 10275879
- K072931 — MC 3003G-32R HEAD COIL
- K062542 — Z-LOOK3 DENTAL IMPLANT SYSTEM, MODEL Z3-XXX
- K071445 — TERRAQUANT MQ2000 V.5 WITH THE TQ-1TENS
- K071912 — APACERAM BONE GRAFT SUBSTITUTE
- K071990 — VALEO CERVICAL PLATE SYSTEM
- K072091 — D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
- K072298 — BIOPRO MEMORY STAPLE, MODELS 18062-18073
- K072343 — NEUROVISION JJB SYSTEM
- K072918 — MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00
- K071313 — TROJAN-ENZ BRAND
- K071493 — CLEVER CHEK TD-4209 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4209, TD-4222, TD-4225
- K071787 — BEMITT, MODEL 0001
- K071981 — BONART MODEL ART-P6 PIEZO ELECTRIC ULTRASONIC SCALER & ACCESSORIES (TIPS)
- K072026 — RNK ELECTRONIC STETHOSCOPE
- K072063 — KFX TISSUE FIXATION SYSTEM AND ACCESSORIES
- K072086 — INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
- K072200 — STIMLAB
- K072262 — GENTLERAY 980 DIODE LASER SYSTEM
- K072506 — EXACTRAC 5.5
- K072529 — TRACKPORT
- K072545 — ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
- K072612 — ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
- K072727 — INRATIO 2 PT MONITORING SYSTEM
- K072900 — EXCELARREST FOAM
- K071652 — HEMOCUE WBC SYSTEM
- K071737 — GENERAL SEMEN ANALYSIS KIT
- K071904 — DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
- K072083 — SMALL FRAGMENT LOCKING PLATING SYSTEM
- K072191 — CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
- K072294 — SYSTEM-MINI, MODELS: 390, E30
- K072472 — DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED
- K072680 — DRYSTAR AXYS, MODEL EYZ4E
- K072800 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K072898 — HEXAPOD EVO RT COUCH TOP
- K070265 — DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
- K070749 — ESTECH PERCUTANEOUS INSERTION DILATOR KIT
- K071764 — REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
- K072081 — ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM
- K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
- K072422 — CYBERWAND STERILE PADS, MODEL: CW-RBPBX
- K072706 — MICROCHOICE DRILLS AND SAWS, MICROPOWER DRILLS AND SAWS, MICROPOWER ORALMAX HIGH SPEED DRILL
- K072826 — APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM
- K070520 — PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
- K070865 — EXPANDING VASCULAR SHEATH
- K071046 — SYNTHES CHRONOS COMPOSITE
- K071070 — OLYMPUS DENTAL IMPLANT SYSTEM
- K071271 — BIOMET CABLE SYSTEM
- K071726 — ZUMA
- K071833 — MOSAIC DEVICES
- K072362 — NOVALUNG SURGICAL LUNG ASSIST (SLA) MEMBRANE LUNG
- K072519 — ACTIVATOR V SPINAL ADJUSTING INSTRUMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.