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
34873–34896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 2015
HumaPen Luxura
K142518 · FMF
Eli Lilly and Company
General Hospital · 270d
Cleared Jun 05, 2015
Metallic Locking Bone Plate and Screw System
K143002 · HRS
Changzhou Dingjian Medical Appliance...
Orthopedic · 228d
Cleared Jun 05, 2015
Phasix ST Mesh
K143380 · OWT
C.R. Bard, Inc.
General & Plastic Surgery · 192d
Cleared Jun 05, 2015
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K143715 · LYZ
Better Plastic Co., Ltd.
General Hospital · 158d
Cleared Jun 05, 2015
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC)...
K150109 · FOZ
Arrow International (A Subsidiary of...
General Hospital · 136d
Cleared Jun 05, 2015
MCL 31 Dermablate
K150140 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 134d
Cleared Jun 05, 2015
Chariot Guiding Sheath
K150186 · DYB
Boston Scientific Corp
Cardiovascular · 129d
Cleared Jun 05, 2015
DPZ Pedicular Fixation System
K150294 · MNI
Osteomed Implantes, Ltda
Orthopedic · 119d
Cleared Jun 05, 2015
FreeStyle Lite Blood Glucose Monitoring System
K150332 · NBW
Abbott Laboratories
Chemistry · 115d
Cleared Jun 05, 2015
Freedom Spinal Cord Stimulator System
K150517 · GZB
Stimwave Technologies Incorporated
Neurology · 95d
Cleared Jun 05, 2015
FreeStyle Freedom Lite Blood Glucose Monitoring System
K150531 · NBW
Abbott Laboratories
Chemistry · 95d
Cleared Jun 05, 2015
Ez3D-i/E3
K150761 · LLZ
Ewoosoft Co., Ltd.
Radiology · 74d
Cleared Jun 05, 2015
MUSE System
K151001 · ODE
Medigus , Ltd.
Gastroenterology & Urology · 51d
Cleared Jun 05, 2015
Ultrasound System SONIMAGE HS1
K151060 · IYO
Konica Minolta, Inc.
Radiology · 46d
Cleared Jun 05, 2015
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine...
K151203 · LDJ
Immunalysis Corporation
Toxicology · 31d
Cleared Jun 04, 2015
Fixtemp Cement
K142446 · EMA
Exacta Dental Direct, Inc.
Dental · 275d
Cleared Jun 04, 2015
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31,...
K142595 · PDJ
Ortho-Clinical Diagnostics
Chemistry · 262d
Cleared Jun 04, 2015
INTRAGen
K142833 · OUH
Jeisys Medical, Inc.
General & Plastic Surgery · 247d
Cleared Jun 04, 2015
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire...
K143041 · LIT
Natec Medical , Ltd.
Cardiovascular · 225d
Cleared Jun 04, 2015
WIRION
K143570 · NTE
Gardia Medical
Cardiovascular · 169d
Cleared Jun 04, 2015
Alevicyn SG Antipruritic Gel
K143590 · FRO
Oculus Innovative Sciences
General & Plastic Surgery · 168d
Cleared Jun 04, 2015
CreoDent Solidex Customized Abutment
K150012 · NHA
Creodent Prosthetics, Ltd.
Dental · 150d
Cleared Jun 04, 2015
Remington Medical Inc. Tuohy Epidural Needles
K150266 · BSP
Remington Medical, Inc.
Anesthesiology · 120d
Cleared Jun 04, 2015
ToeTac Hammertoe Fixation System
K150443 · HWC
Restore Surgical, LLC Dba Instratek
Orthopedic · 104d