FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13033–13056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · PBK
Centers For Disease Control and...
Microbiology · 2d
Cleared Jun 09, 2022
ACUTRON
K211000 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 433d
Cleared Jun 09, 2022
Cysto-Gastro-Sets
K211909 · KNS
G-Flex Europe Sprl
Gastroenterology & Urology · 353d
Cleared Jun 09, 2022
KHEIRON® Spinal Fixation System
K211981 · NKB
S.M.A.I.O
Orthopedic · 349d
Cleared Jun 09, 2022
HELIOS IV 785
K212663 · GEX
Laseroptek Co., Ltd.
General & Plastic Surgery · 290d
Cleared Jun 09, 2022
Nasogastric Feeding Tubes - ENFit Port - PVC
K213258 · PIF
Cair Lgl
Gastroenterology & Urology · 252d
Cleared Jun 09, 2022
MyCRO Band
K213587 · MVA
Otto Bock Healthcare LP
Neurology · 209d
Cleared Jun 09, 2022
ALLY Adaptive Cataract Treatment System
K220259 · OOE
Lensar, Inc.
Ophthalmic · 129d
Cleared Jun 09, 2022
RedPoint Medical's Better Bunion System
K220717 · PBF
Redpoint Medical, LLC
Orthopedic · 90d
Cleared Jun 09, 2022
The Luminance RED Acne Device
K220729 · OLP
Luminance Medical Ventures, Inc.
General & Plastic Surgery · 87d
Cleared Jun 09, 2022
IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System,...
K220782 · MAX
Alphatec Spine, Inc.
Orthopedic · 84d
Cleared Jun 09, 2022
EksoNR
K220988 · PHL
Ekso Bionics, Inc.
Neurology · 66d
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