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
6049–6072 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 2024
MICROLET®NEXT Lancet
K241810 · QRK
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 55d
Cleared Aug 15, 2024
NCB® Polyaxial Locking Plate System
K241754 · HRS
Zimmer Switzerland Manufacturing GmbH
Orthopedic · 58d
Cleared Aug 15, 2024
Medifun Safety Lancet ( MSL1 series)
K241750 · FMK
Medifun Corporation
General & Plastic Surgery · 58d
Cleared Aug 15, 2024
uMI Panvivo
K241596 · KPS
Shanghai United Imaging Healthcare...
Radiology · 73d
Cleared Aug 15, 2024
NPseal (20 and 25)
K241522 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 78d
Cleared Aug 15, 2024
Connected OR Hub with Device and Voice Control
K241401 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 90d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 15, 2024
Disposable Pen Injector Assembly
K240961 · FMF
Wuxi Nest Biotechnology Co., Ltd.
General Hospital · 129d
Cleared Aug 15, 2024
TOV Dental Implant System
K240837 · DZE
Rdj Tov Implant, Ltd.
Dental · 141d
Cleared Aug 15, 2024
UltraDrape UGPIV Barrier and Securement (34-15)
K233965 · ITX
Parker Laboratories, Inc.
Radiology · 244d
Cleared Aug 15, 2024
Sapphire ULTRA Coronary Dilatation Catheter
K233505 · LOX
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 289d
Cleared Aug 14, 2024
PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup
K242077 · NFT
Aicheck Biotech, Inc.
Toxicology · 29d
Cleared Aug 14, 2024
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens...
K242059 · LPL
X-Cel Specialty Contacts, A Walman...
Ophthalmic · 30d
Cleared Aug 14, 2024
COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED,...
K242057 · GXD
Avanos Medical, Inc.
Neurology · 30d
Cleared Aug 14, 2024
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel
K241969 · NGL
Qingdao Hightop Biotech Co., Ltd.
Toxicology · 40d
Cleared Aug 14, 2024
Intimate Rose Vaginal Dilators
K241748 · HDX
Plus EV Holdings Dba Intimate Rose
Obstetrics & Gynecology · 57d
Cleared Aug 14, 2024
BostonSight® Specialty Lenses
K241571 · HQD
Boston Foundation For Sight, Inc....
Ophthalmic · 75d
Cleared Aug 14, 2024
CROSSLEAD Tracker
K241510 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 77d
Cleared Aug 14, 2024
Catapult Guide Sheath
K240957 · DYB
Contract Medical International, GmbH
Cardiovascular · 128d
Cleared Aug 14, 2024
TRAUMAGEL®
K240713 · QSY
Cresilon, Inc.
General & Plastic Surgery · 152d
Cleared Aug 14, 2024
Utepreva Endometrial Sampler (UP01)
K240595 · HFE
Utepreva, LLC
Obstetrics & Gynecology · 163d
Cleared Aug 14, 2024
Family of DIMAR DMAX NIV masks
K232836 · CBK
Dimar S.P.A.
Anesthesiology · 335d
Cleared Aug 13, 2024
Shinetell Digital Pregnancy Test
K241978 · LCX
Hangzhou AllTest Biotech Co., Ltd.
Chemistry · 39d
Cleared Aug 13, 2024
SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System
K241813 · OUR
Si-Technology, LLC
Orthopedic · 53d