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
30721–30744 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 2016
Nanova Interference Screw
K161174 · MAI
Nanova Biomaterials, Inc.
Orthopedic · 191d
Cleared Nov 03, 2016
Nunchaku
K161373 · OKS
Fci (France Chirurgie Instrumentation)
Ophthalmic · 170d
Cleared Nov 03, 2016
MatrixRIB Fixation System
K161590 · HRS
Synthes USA Products, LLC
Orthopedic · 147d
Cleared Nov 03, 2016
Persona Partial Knee System
K161592 · HSX
Biomet, Inc.
Orthopedic · 147d
Cleared Nov 03, 2016
MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV...
K161779 · FOZ
Medsource International, LLC
General Hospital · 127d
Cleared Nov 03, 2016
Avance Gauze Dressing Kits
K161948 · OMP
Molnlycke Health Care Us, LLC
General & Plastic Surgery · 111d
Cleared Nov 03, 2016
MicrUs
K161968 · IYO
Telemed
Radiology · 108d
Cleared Nov 03, 2016
CastleLoc-S Posterior Cervical Fixation System
K162136 · NKG
L & K Biomed Co., Ltd.
Orthopedic · 94d
Cleared Nov 03, 2016
Senographe Pristina
K162268 · MUE
Ge Healthcare
Radiology · 83d
Cleared Nov 03, 2016
CastleLoc Spinal Fixation System
K162801 · MNH
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared Nov 02, 2016
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed...
K160421 · NLH
Innovative Health, LLC
Cardiovascular · 260d
Cleared Nov 02, 2016
Boosting Catheter
K160561 · DQY
Qxmedical, LLC
Cardiovascular · 247d
Cleared Nov 02, 2016
CARDIOLINE touchECG
K160746 · DPS
Cardioline S.P.A
Cardiovascular · 229d
Cleared Nov 02, 2016
Durepair Dura Regeneration Matrix
K161370 · GXQ
Medtronic Neurosurgery
Neurology · 169d
Cleared Nov 02, 2016
joimax Electrosurgical Instruments
K161378 · GEI
Joimax GmbH
General & Plastic Surgery · 168d
Cleared Nov 02, 2016
Lucid Q-PTP / HWA 55
K161670 · GEX
Bison Medical Co, Ltd.
General & Plastic Surgery · 139d
Cleared Nov 02, 2016
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with...
K162095 · LZA
Yty Industry (Manjung) Sdn Bhd
General Hospital · 97d
Cleared Nov 01, 2016
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
K160895 · LZO
Kyocera Medical Corporation
Orthopedic · 215d
Cleared Nov 01, 2016
Propeller Sensor Model 2015-E
K161454 · CAF
Reciprocal Labs Corporation
Anesthesiology · 159d
Cleared Nov 01, 2016
Anatomical Shoulder Domelock Dome centric
K161620 · HSD
Zimmer GmbH
Orthopedic · 141d
Cleared Nov 01, 2016
SLENDERTONE® Connect Abs, Type 570
K161974 · NGX
Bio-Medical Research, Ltd.
Physical Medicine · 106d
Cleared Nov 01, 2016
Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing...
K162002 · IYE
Zdi, Solutions, LLC
Radiology · 104d
Cleared Nov 01, 2016
AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
K162062 · HRX
Stryker Corporation
Orthopedic · 98d
Cleared Nov 01, 2016
Xario 200 Diagnostic Ultrasound System V5.0
K162155 · IYN
Toshibamedical Systems Corporation
Radiology · 91d