Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
61873–61896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2006
PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM
K061529 · NHA
Nobel Biocare AB
Dental · 82d
Cleared Aug 23, 2006
RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER
K061674 · HLI
Talia Technology , Ltd.
Ophthalmic · 70d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K061872 · LRG
Dade Behring, Inc.
Microbiology · 51d
Cleared Aug 23, 2006
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90,...
K062145 · DYB
Acumen Medical, Inc.
Cardiovascular · 27d
Cleared Aug 23, 2006
MODIFICATION TO BONE GRAFT SYRINGE
K062173 · FMF
Wrightmedicaltechnologyinc
General Hospital · 23d
Cleared Aug 23, 2006
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 -...
K062179 · LRG
Dade Behring, Inc.
Microbiology · 23d
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · JTN
Hardy Diagnostics
Microbiology · 21d
Cleared Aug 23, 2006
MICROSCAN MICROSTREP PLUS PANEL
K062276 · LRG
Dade Behring, Inc.
Microbiology · 16d
Cleared Aug 23, 2006
APOLLO GAMMA CAMERA SYSTEM
K062298 · KPS
Adac Laboratories
Radiology · 15d
Cleared Aug 22, 2006
CG-6108 ARRHYTHMIA ECG EVENT RECORDER
K060911 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 141d
Cleared Aug 22, 2006
TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500
K061369 · DWA
Cardiacassist, Inc.
Cardiovascular · 97d
Cleared Aug 22, 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 22, 2006
ARX SPINAL SYSTEM
K061600 · MNI
Life Spine
Orthopedic · 75d
Cleared Aug 22, 2006
JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
K061628 · DTZ
Maquet Cardiopulmonary, AG
Cardiovascular · 71d
Cleared Aug 22, 2006
NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
K061866 · JOW
Thermotek, Inc.
Cardiovascular · 50d
Cleared Aug 22, 2006
MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302,...
K061959 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 42d
Cleared Aug 22, 2006
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
K062134 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 27d
Cleared Aug 22, 2006
BIOKNOTLESS AND LUPINE PLUS ANCHORS
K062170 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 22d
Cleared Aug 21, 2006
ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L
K053555 · ELC
Guilin Woodpecker Medical Instrument...
Dental · 244d
Cleared Aug 21, 2006
VECTORVISION HIP
K060727 · HAW
Brainlab AG
Neurology · 157d
Cleared Aug 21, 2006
VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE
K061433 · MBH
Biomet Manufacturing, Inc.
Orthopedic · 89d
Cleared Aug 21, 2006
UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS
K061457 · LFG
Ucp Biosciences, Inc.
Toxicology · 88d
Cleared Aug 21, 2006
PROCERA TITANIUM ABUTMENT FOR ASTRATECH AND CAMLOG IMPLANT SYSTEMS
K061478 · NHA
Nobel Biocare AB
Dental · 83d
Cleared Aug 21, 2006
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM
K061480 · DQY
Medtronic, Ireland
Cardiovascular · 83d