FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
13321–13344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 2022
Niti-S Biliary Slim M Stent
K221071 · FGE
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Jun 09, 2022
Auryon Atherectomy System
K221077 · MCW
Eximo Medical, Ltd.
Cardiovascular · 58d
Cleared Jun 09, 2022
Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection
K221339 · LIT
Contego Medical, Inc.
Cardiovascular · 31d
Cleared Jun 09, 2022
Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
K221368 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 28d
Cleared Jun 08, 2022
INHANCETM Hybrid Anatomic Glenoid Implant
K212933 · MBF
Depuy Ireland UC
Orthopedic · 266d
Cleared Jun 08, 2022
TrabEx Pro
K213173 · MRH
Microsurgical Technologies, Inc.
Ophthalmic · 253d
Cleared Jun 08, 2022
ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone...
K213185 · FAD
Coloplast Corp.
Gastroenterology & Urology · 252d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 08, 2022
HD60 Series Ultrasound Diagnostic System
K213862 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 180d
Cleared Jun 08, 2022
EarliPoint System
K213882 · QPF
Earlitec Diagnostics, Inc.
Neurology · 177d
Cleared Jun 08, 2022
Promisemed Heel Blood Lancet
K221371 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 27d
Cleared Jun 08, 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221389 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Jun 07, 2022
Infinity Gateway Suite
K203579 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 547d
Cleared Jun 07, 2022
Adhese Universal DC, Cention Primer
K210804 · KLE
Ivoclar Vivadent, AG
Dental · 447d
Cleared Jun 07, 2022
Natural Rubber Latex Ultrasound Transducer Probe Covers
K213087 · ITX
Global Protection Corp.
Radiology · 256d
Cleared Jun 07, 2022
FX V135 Shoulder Prosthesis
K213117 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 253d
Cleared Jun 07, 2022
Lap-Band System Calibration Tube
K220455 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 110d
Cleared Jun 07, 2022
Zoupure Nitrile Powder Free Examination glove
K220693 · LZA
Thai Rayong Product Glove Zoupure...
General Hospital · 90d
Cleared Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · PQA
Cepheid
Microbiology · 47d
Cleared Jun 07, 2022
D²RS and D²RS 9090
K221335 · OWB
Stephanix
Radiology · 29d
Cleared Jun 07, 2022
WHILL Model F
K221438 · ITI
Whill, Inc.
Physical Medicine · 21d
Cleared Jun 06, 2022
Diacare 7000
K211207 · PBX
Globus Sport and Health Technologies,...
General & Plastic Surgery · 410d
Cleared Jun 06, 2022
Keos Anterior Cervical Interbody Fusion Device System
K212450 · ODP
Keos
Orthopedic · 305d
Cleared Jun 06, 2022
Disposable Polypectomy Snare
K213222 · FDI
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d