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
34921–34944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2015
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER
K141531 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 357d
Cleared Jun 01, 2015
VX120 Ophthalmic Diagnostic Device
K143086 · HKX
Luneau Sas
Ophthalmic · 217d
Cleared Jun 01, 2015
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate...
K143335 · FRO
Roosin Medical Devices Co., Ltd.
General & Plastic Surgery · 193d
Cleared Jun 01, 2015
ICIS View
K143397 · LLZ
Agfa Healthcare N.V.
Radiology · 187d
Cleared Jun 01, 2015
Reactor(TM) Trocar and Sleeve
K150549 · GCJ
Sharp Medical Prducts, LLC
General & Plastic Surgery · 90d
Cleared Jun 01, 2015
cobas HSV 1 and 2 Test
K150617 · OQO
Roche Molecular Systems, Inc.
Microbiology · 83d
Cleared Jun 01, 2015
PROBEAT-V
K151132 · LHN
Hitachi, Ltd., Health Care Company
Radiology · 34d
Cleared May 31, 2015
Occlusion Balloon Catheter
K142692 · MJN
Embolx, Inc.
Cardiovascular · 251d
Cleared May 30, 2015
Optilite IgG4 Kit
K150526 · CFN
The Binding Site Group , Ltd.
Immunology · 89d
Cleared May 29, 2015
STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE...
K141907 · CHL
Nova Biomedical Corporation
Chemistry · 318d
Cleared May 29, 2015
SP-1PSpecular Microscope
K142417 · NQE
Topcon Corporation
Ophthalmic · 274d
Cleared May 29, 2015
opti-Toe
K142478 · HTY
Graham Medical Technologies, LLC...
Orthopedic · 268d
Cleared May 29, 2015
Instru-Safe Instrument Protection System
K142768 · KCT
Summit Medical, Inc.
General Hospital · 246d
Cleared May 29, 2015
Azure Anterior Cervical Plate System
K143028 · KWQ
Orthofix, Inc.
Orthopedic · 220d
Cleared May 29, 2015
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · LZH
Covidien
General Hospital · 197d
Cleared May 29, 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · HSB
Zimmer, Inc.
Orthopedic · 191d
Cleared May 29, 2015
SmartTENS
K143430 · NUH
Easy Med Instrument Co., Ltd.
Neurology · 179d
Cleared May 29, 2015
Piccolo Composite Plate System
K143496 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 171d
Cleared May 29, 2015
Prime Adaptive Ultrasonic Scalpel System
K150271 · LFL
Endoprime, Inc.
General & Plastic Surgery · 114d
Cleared May 29, 2015
Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System
K150544 · JWH
Aesculap Implant Systems, LLC
Orthopedic · 87d
Cleared May 29, 2015
EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive...
K150679 · PIF
Boston Scientific Corp
Gastroenterology & Urology · 73d
Cleared May 29, 2015
Various Brands of Ultraviolet Lamps
K150778 · LEJ
Cosmedico Light, Inc.
General & Plastic Surgery · 65d
Cleared May 29, 2015
MAGEC 2 Spinal Bracing and Distraction System
K150885 · PGN
Ellipse Technologies, Incorporated
Orthopedic · 57d
Cleared May 29, 2015
Para-Fix C&S Medium
K150887 · JSM
Medical Chemical Corporation
Microbiology · 57d