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
29017–29040 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 25, 2017
KARL STORZ ICG Imaging System
K171238 · OWN
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 28d
Cleared May 25, 2017
Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492...
K171253 · LDF
Medtronic
Cardiovascular · 27d
Cleared May 24, 2017
Gems Vitrification Set, Gems Warming Set
K162409 · MQL
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 268d
Cleared May 24, 2017
GCE Zen-O Portable Oxygen Concentrator
K162433 · CAW
Oxus, Inc.
Anesthesiology · 266d
Cleared May 24, 2017
Matrix Data Management System
K162463 · DXN
Global Instrumentation, LLC
Cardiovascular · 264d
Cleared May 24, 2017
vascuCAP
K163071 · LLZ
Elucid Bioimaging, Inc.
Radiology · 203d
Cleared May 24, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K163172 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 191d
Cleared May 24, 2017
ACTION II Laser System
K163196 · GEX
Lutronic Corporation
General & Plastic Surgery · 190d
Cleared May 24, 2017
Cook Holmium Laser Fiber
K163197 · GEX
Cook Incorporated
General & Plastic Surgery · 190d
Cleared May 24, 2017
truFreeze System
K163244 · GEH
CSA Medical, Inc.
General & Plastic Surgery · 187d
Cleared May 24, 2017
VitreOx Anti-fog Solution
K163257 · OCT
Sio2 Nanotech, LLC
Gastroenterology & Urology · 191d
Cleared May 24, 2017
INDIGO Aspiration System
K163618 · QEX
Penumbra, Inc.
Cardiovascular · 153d
Cleared May 24, 2017
UNiD Spine Analyzer
K170172 · LLZ
Medicrea International
Radiology · 125d
Cleared May 24, 2017
Dental Implants OKTAGON Bone Level Tapered Design
K170287 · DZE
Hager& Meisinger GmbH
Dental · 114d
Cleared May 24, 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for...
K170290 · LZA
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared May 24, 2017
FIBERGRAFT BG Putty Bone Graft Substitute
K170306 · MQV
Prosidyan, Inc.
Orthopedic · 113d
Cleared CT May 24, 2017
RA-308 Excimer Laser System, Excimer Laser Catheter
K170349 · PDU
Ra Medical Systems,Inc
Cardiovascular · 110d
Cleared May 24, 2017
Central Monitoring System
K170514 · MHX
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 92d
Cleared May 24, 2017
Tao Brush I.U.M.C. Endometrial Sampler
K170603 · HFE
Cook Incorporated
Obstetrics & Gynecology · 84d
Cleared May 24, 2017
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50...
K170779 · LYY
Terang Nusa Sdn Bhd
General Hospital · 70d
Cleared May 24, 2017
Mako Partial Knee Application
K170891 · OLO
Mako Surgical Corp.
Orthopedic · 58d
Cleared May 24, 2017
AS-10, CXDI-401RF
K171194 · OWB
Canon, Inc.
Radiology · 30d
Cleared May 23, 2017
LATEX EXAMINATION GLOVE POWDER FREE
K161833 · LYY
Careglove Global Sdn. Bhd.
General Hospital · 322d
Cleared May 23, 2017
HAPI Seal
K162598 · EBC
Bisco, Inc.
Dental · 246d