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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
52033–52056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared CT Oct 16, 2009
GUIDED MEASUREMENT CATHETER (GMC)
K091780 · DQO
Mediguide, Ltd.
Cardiovascular · 121d
Cleared CT Oct 16, 2009
GUIDED MEDICAL POSITIONING SYSTEM (GMPS)
K091781 · DQK
Mediguide, Ltd.
Cardiovascular · 121d
Cleared Oct 16, 2009
GEM-STONE ABDOMINAL TRAINING SYSTEM
K091833 · NGX
Gemore Technology Co, Ltd.
Physical Medicine · 116d
Cleared Oct 16, 2009
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · JFJ
Beckman Coulter, Inc.
Chemistry · 116d
Cleared Oct 16, 2009
NOBEL/PROCERA IMPLANT BRIDGE
K091848 · NHA
Nobel Biocare AB
Dental · 116d
Cleared Oct 16, 2009
IDENTEVENT, VERSION 1.0G
K092039 · OMB
Optima Neuroscience, Inc.
Neurology · 102d
Cleared Oct 16, 2009
CYPHER DICOM PRINT SOLUTION
K092280 · LMC
Virtual Imaging, Inc.
Radiology · 80d
Cleared Oct 16, 2009
PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS
K092337 · GXI
Baylis Medical Co., Inc.
Neurology · 73d
Cleared Oct 16, 2009
ABX PENTRA TPU CAL, MODEL A11A01898
K092570 · JIT
HORIBA ABX SAS
Chemistry · 56d
Cleared Oct 16, 2009
SJM ATTUNE ANNULOPLASTY RING
K092876 · KRH
St Jude Medical
Cardiovascular · 28d
Cleared Oct 16, 2009
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER
K092879 · GEI
Valleylab
General & Plastic Surgery · 28d
Cleared Oct 16, 2009
EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
K092913 · JOQ
Ep Medsystems
Cardiovascular · 24d
Cleared Oct 15, 2009
LIFEBRIDGE B2T, MODEL 7001
K090006 · DTQ
Lifebridge Medizintechnik AG
Cardiovascular · 286d
Cleared Oct 15, 2009
TANDA RESTORE, MODEL PTSCS
K090008 · ILY
Pharos Life Corporation
Physical Medicine · 286d
Cleared Oct 15, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM,...
K091458 · MJN
Ev3 Neurovascular
Cardiovascular · 150d
Cleared Oct 15, 2009
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
K091471 · LYZ
Cartagloves S.A.
General Hospital · 150d
Cleared Oct 15, 2009
STENT GRAFT BALLOON CATHETER
K091624 · DQY
Via Biomedical, Inc.
Cardiovascular · 134d
Cleared Oct 15, 2009
BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION
K092035 · DZE
Bicon, LLC
Dental · 101d
Cleared Oct 15, 2009
MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6
K092177 · NTE
Invatec S.P.A.
Cardiovascular · 86d
Cleared Oct 15, 2009
C-THRU SPINAL SYSTEM
K092336 · MQP
Ebi, L.P.
Orthopedic · 72d
Cleared Oct 15, 2009
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM
K092691 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 43d
Cleared Oct 15, 2009
MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
K092838 · DQA
Masimo Corporation
Anesthesiology · 30d
Cleared Oct 14, 2009
GRIND GUARD
K090472 · MQC
Archtek, Inc.
Dental · 232d
Cleared Oct 14, 2009
SONICFILL 2010
K091091 · EBF
Sybron Dental Specialties, Inc.
Dental · 181d