FDA 510(k) clearances — page 726
clearances on record, most recent first.
Clearances — page 726
72,501–72,600 of 175,825- K023483 — KALAZAR DETECT
- K023615 — GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR
- K023648 — VISUALINE CUP IV FOR DRUGS OF ABUSE TEST FOR QUALITATIVE DETERMINATION OF COCAINE, CANNABINOIDS, MORPHINE, METHAMPHETAMI
- K023734 — ARAMIS II DERMATOLOGICAL LASER
- K023759 — CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER
- K023943 — CT COLONOGRAPHY
- K030450 — 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
- K030536 — LAC-MAC LIMITED INNERBLOC O.R. GOWN
- K030580 — SURETEMP PLUS
- K030646 — BELLEGLASS POINT 4
- K030786 — MONO-SWIFT
- K031072 — DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN E
- K031186 — LUMINEXX ENDOSCOPIC BILIARY STENT
- K031261 — CARD EP
- K031270 — ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS
- K031312 — RTA MODEL D RETINAL THICKNESS ANALYZER
- K031320 — EK-PRO ARRHYTHMIA DETECTION ALGORITHM
- K011399 — BIOMET CRANIOFACIAL ACRYLIC CEMENT
- K023230 — ECHOPULSE MUSCLE STIMULATOR SYSTEM, MODEL 800
- K023963 — ADHOC CLAW
- K030371 — PRIMA III TOTALSENSE TORSO COIL
- K030375 — SOFT-TOUCH TENS ELECTRODE
- K031129 — POLY PER-Q-CATH PICC CATHETERS; POLY RADPICC
- K031178 — SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES
- K031291 — CDR PANX, MODEL 4792
- K021952 — HIVOX DREAMATE DM-800
- K023286 — CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
- K023654 — GLYCA-DIRECT FRUCTOSAMINE
- K023673 — AIRLIFE DEMAND NASAL CANNULA
- K024289 — BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
- K030026 — REPROCESSED ELECTROPHYSIOLOGY CATHETER
- K030207 — NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
- K030343 — DIEGO POWERED DISSECTOR HANDPIECE WITH STARLINK IMAGE-GUIDED ADAPTER MOUNTING INTERFACE
- K030346 — TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
- K030347 — 20.1 MONOCHROME LCD MONITOR, RADIFORCE G20
- K030349 — HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
- K030488 — FLUORILAQ
- K030489 — BRM2 BRAIN MONITOR
- K030515 — HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
- K030607 — KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES
- K030659 — CLEARBLUE EASY DIGITAL PREGNANCY TEST
- K030929 — ANA DETECT
- K030997 — POWDERED VINYL EXAM GLOVES, WHITE
- K031062 — TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
- K031223 — SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
- K031226 — STERRAD CYCLESURE BIOLOGICAL INDICATOR
- K031230 — GE PROPELLER IMAGING OPTION FOR MRI
- K031257 — RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
- K031269 — ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
- K031297 — ACCESS OV MONITOR ASSAY
- K023602 — SMALL VOLUME NEBULIZER
- K024175 — SUNPEX TECHNOLOGIES MODEL PW
- K030017 — CHUMP
- K030432 — IMC-HEARTWAY MODEL HPS ELECTRIC POWERED WHEELCHAIR
- K030433 — STRATUSOCT WITH RNFL NORMATIVE DATABASE
- K030733 — MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
- K030741 — AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
- K030759 — LITTLE COACH
- K030933 — PASCO MIC AND MIC/ID PANELS
- K031162 — SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
- K031202 — MEDIPALM-20
- DEN030001 — NIOX ARTICLE NO: 02-1000
- K023847 — HEMO-STREAM HEMODIALYSIS CATHETER SET
- K023869 — 'RAPIDTEC'-5M-MULTIPLE DIP TEST
- K023905 — ATHENA PELVIC MUSCLE TRAINER
- K030415 — ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
- K030451 — CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE
- K030690 — CODONICS EP-1000 MEDICAL COLOR DRY IMAGERS
- K031185 — ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE
- K031213 — AQUASENS FLUID MONITORING SYSTEM
- K020418 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- K020421 — GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
- K020925 — CARBODISSECTING ENDOSCOPE
- K021174 — ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR
- K023672 — X O ODONTOSURGE 4
- K030133 — SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE
- K030303 — FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE
- K030365 — DEROYAL DRAPES, STERILE, NON-STERILE
- K031002 — SYNCHRON SYSTEMS OPIATE REAGENT
- K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS
- K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50
- K030234 — COZART EIA COCAINE ORAL FLIUD KIT
- K030297 — FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130
- K030364 — DEROYAL GOWNS, STERILE, NON-STERILE
- K030405 — QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075
- K030428 — ROCHE ONLINE TDM PHENYTOIN
- K030585 — SCULPTING RESIN
- K030942 — MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
- K031009 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM
- K031028 — THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- K031127 — ORTHOPEDIC WIRE
- K022294 — APNEACHECK
- K030233 — TRAVELSOME STANDARD
- K030272 — FLAT PANEL DISPLAY, ME183L
- K030274 — MEDICAL FLAT PANEL DISPLAY, ME315L
- K030276 — FLAT PANEL DISPLAYS, CDL SERIES
- K030353 — MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
- K030959 — BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100
- K030974 — EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170
- K030975 — EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210
Data sourced from openFDA. This site is unofficial and independent of the FDA.