FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
29065–29088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2017
PIEZOTOME M+, PIEZOTOME M+ Handpiece
K163610 · JDX
Satalec-Acteon Group
Orthopedic · 148d
Cleared May 19, 2017
Nihon Kohden QP-160AK EEG Trend Program
K163644 · OMA
Nihon Kohden Corporation
Neurology · 147d
Cleared May 19, 2017
StealthStationTM S8 ENT Software
K170018 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 136d
Cleared May 19, 2017
E5 Series Digital Color Doppler Ultrasound System
K170303 · IYN
Sonoscape Medical Corp.
Radiology · 108d
Cleared May 19, 2017
Catalys Precision Laser System
K170322 · OOE
Abbott Medical Optics, Inc.
Ophthalmic · 107d
Cleared May 19, 2017
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200...
K170509 · PUQ
Bio-Rad Laboratories
Microbiology · 87d
Cleared May 19, 2017
OEC Elite
K170752 · OWB
Oec Medical Systems, Inc.
Radiology · 67d
Cleared May 19, 2017
Eko Model E5 System (EME5), Eko DUO
K170874 · DQD
Eko Devices, Inc.
Cardiovascular · 56d
Cleared May 19, 2017
PK AIM
K170908 · GEI
Gyrus Acmi, Inc.
General & Plastic Surgery · 52d
Cleared May 19, 2017
Stryker Universal Neuro III System AXS Screw
K171152 · HBW
Stryker
Neurology · 29d
Cleared May 18, 2017
Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube
K160509 · KNT
Cook Incorporated
Gastroenterology & Urology · 449d
Cleared May 18, 2017
Barone Jejunostomy Catheter Set
K160567 · KNT
Cook Incorporated
Gastroenterology & Urology · 444d
Cleared May 18, 2017
Supreme and Response Electrophysiology Catheters
K161272 · NLH
Surgical Instrument Service and...
Cardiovascular · 378d
Cleared May 18, 2017
bibag
K162716 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 231d
Cleared May 18, 2017
HEALIX ADVANCE Anchor with PERMATAPE Suture
K170639 · MAI
Medos International SARL
Orthopedic · 77d
Cleared May 18, 2017
The Solstice OCT System
K170804 · NKG
Life Spine, Inc.
Orthopedic · 62d
Cleared May 18, 2017
Lipogems System
K171135 · MUU
Lipogems International Spa
General & Plastic Surgery · 31d
Cleared May 18, 2017
LaparoLight Veress Needle
K171139 · HIF
Buffalo Filter, LLC
Obstetrics & Gynecology · 30d
Cleared May 18, 2017
SmartByte Device
K171165 · ONY
Scientific Intake
Gastroenterology & Urology · 28d
Cleared May 17, 2017
AirLife Misty Finity Nebulizer
K153748 · CAF
Care Fusion
Anesthesiology · 505d
Cleared May 17, 2017
MRI Compatibility for Existing Zimmer Dental Implant Systems
K160398 · DZE
Zimmer Dental, Inc.
Dental · 460d
Cleared May 17, 2017
Dynamika
K161601 · LLZ
Image Analysis Limited
Radiology · 342d
Cleared May 17, 2017
FREND PSA PLUS (reagent cartridge)
K162378 · LTJ
Nanoentek USA, Inc.
Immunology · 266d
Cleared May 17, 2017
TinniLogic Mobile Tinnitus Management Device
K163094 · KLW
Jiangsu Betterlife Medical Co., Ltd.
Ear, Nose, Throat · 194d