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
12289–12312 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2022
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
K211892 · MQP
Arftx Medical, LLC
Orthopedic · 472d
Cleared Oct 06, 2022
A&D Medical UM-212BLE Blood Pressure Monitor
K212168 · DXN
A&D Company, Ltd.
Cardiovascular · 451d
Cleared Oct 06, 2022
NuCath Wedge Pressure Catheter
K213666 · DQO
Pfm Medical, Inc.
Cardiovascular · 318d
Cleared Oct 06, 2022
Gemini Sterilization Wrap
K220365 · FRG
Medline Industries, LP
General Hospital · 240d
Cleared Oct 06, 2022
iCare IC200
K220852 · HKY
Icare Finland OY
Ophthalmic · 197d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Oct 06, 2022
InfaTherm Disposable Infant Warming Mattress
K221653 · IMD
International Biomedical
Physical Medicine · 121d
Cleared Oct 06, 2022
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore...
K221889 · LRK
Prosomnus Sleep Technologies
Dental · 99d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 06, 2022
PRIMA TT Glenoid
K222427 · MBF
Lima Corporate S.P.A.
Orthopedic · 56d
Cleared Oct 06, 2022
b-ONER MOBIO Total Knee System
K222431 · JWH
B-One Ortho, Corp.
Orthopedic · 56d
Cleared Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686 · EIH
Vatech Acucera, Inc.
Dental · 30d
Cleared Oct 06, 2022
Tibial baseplate, Tibial insert
K222700 · JWH
United Orthopedic Corporation
Orthopedic · 29d
Cleared Oct 05, 2022
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
K212779 · GJS
Coagusense, Inc.
Hematology · 399d
Cleared Oct 05, 2022
Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP
K220138 · GEI
Led Spa
General & Plastic Surgery · 260d
Cleared Oct 05, 2022
ClearCorrect System
K220140 · NXC
Clearcorrect, LLC
Dental · 260d
Cleared Oct 05, 2022
Colibrí System
K220546 · LON
Copan Wasp Srl
Microbiology · 222d
Cleared Oct 05, 2022
Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II
K221128 · MAI
Arthrex, Inc.
Orthopedic · 170d
Cleared Oct 05, 2022
Cornisol
K221759 · LYX
Aurolab
Ophthalmic · 110d
Cleared Oct 05, 2022
VISIONAIR
K221892 · BXQ
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Oct 05, 2022
FaSet Fixation System
K222515 · MRW
Dio Medical Corporation
Orthopedic · 47d
Cleared Oct 05, 2022
Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US)
K222737 · FGB
Shanghai AnQing Medical Instrument...
Gastroenterology & Urology · 26d
Cleared Oct 04, 2022
HemosIL Liquid Anti-Xa
K213464 · KFF
Instrumentation Laboratory CO
Hematology · 341d
Cleared Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
K220683 · QEW
Penumbra, Inc.
Cardiovascular · 210d