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
34225–34248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 2015
GranOSTM - beta tricalcium phosphate synthetic bone granules
K143692 · MQV
Tcm Associates, Ltd.
Orthopedic · 240d
Cleared Aug 21, 2015
SYNFIX Evolution Secured Spacer System
K150673 · OVD
Synthes USA Products, LLC
Orthopedic · 158d
Cleared Aug 21, 2015
PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory...
K150704 · EMA
Kuraray Noritake Dental, Inc.
Dental · 156d
Cleared Aug 21, 2015
CS 8100SC, CS8100SC Access
K151087 · MUH
Trophy
Radiology · 120d
Cleared Aug 21, 2015
UCP Drug Test Mini Cups
K151213 · DKZ
Ucp Biosciences, Inc.
Toxicology · 107d
Cleared Aug 21, 2015
LightStim for Pain LED Belt
K151333 · ILY
Led Intellectual Properties, LLC
Physical Medicine · 94d
Cleared Aug 21, 2015
Reform Pedicle Screw System
K151422 · NKB
Precision Spine, Inc.
Orthopedic · 85d
Cleared Aug 21, 2015
Capillus82
K151516 · OAP
Capillus, LLC
General & Plastic Surgery · 77d
Cleared Aug 21, 2015
STERISPINE LC CAGE
K151756 · MAX
Safe Orthopaedics
Orthopedic · 53d
Cleared Aug 21, 2015
SALVATION® External Fixation System
K152045 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Aug 20, 2015
PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION...
K141017 · OMP
Kci USA, Inc. (Kinetic Concepts, Inc.)
General & Plastic Surgery · 486d
Cleared Aug 20, 2015
OC-Light S FIT
K143325 · KHE
Eiken Chemical Co., Ltd.
Hematology · 273d
Cleared Aug 20, 2015
Natrelle 133 Plus Tissue Expander
K143354 · LCJ
Allergan, Inc.
General & Plastic Surgery · 269d
Cleared Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · FDA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 248d
Cleared Aug 20, 2015
Cascadia Interbody System
K150481 · MAX
K2m, Inc.
Orthopedic · 177d
Cleared Aug 20, 2015
Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock...
K150648 · MBI
Arthrex, Inc.
Orthopedic · 161d
Cleared Aug 20, 2015
Laparoscope Lens Shield Device
K151117 · GCJ
Medeon Biodesign, Inc.
General & Plastic Surgery · 115d
Cleared Aug 20, 2015
Pirouette 018
K151153 · LIT
Arravasc Limited
Cardiovascular · 112d
Cleared Aug 20, 2015
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS...
K151243 · FCS
Stryker Endoscopy
Gastroenterology & Urology · 101d
Cleared Aug 20, 2015
Turbo High-Flow Non-coring Needle
K151341 · FMI
Norfolk Medical
General Hospital · 93d
Cleared Aug 20, 2015
Frontier Medical Devices Posterior Cable Screw System
K151346 · JDQ
Frontier Medical Devices, Inc.
Orthopedic · 92d
Cleared Aug 20, 2015
HA Minuteman G3 MIS Fusion Plate
K151741 · PEK
Spinal Simplicity, LLC
Orthopedic · 55d
Cleared Aug 20, 2015
HealthMyne PACS
K152186 · LLZ
Healthmyne, Inc.
Radiology · 15d
Cleared Aug 19, 2015
STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
K150220 · GWF
Eb Neuro S.P.A.
Neurology · 201d