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

Filters: Cleared only ×
175,820 results
17257–17280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2021
Umbilical Vessels Catheter
K201697 · FOS
Haolang Medical USA Corporation
General Hospital · 318d
Cleared May 06, 2021
SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
K201936 · KPE
Gilero, LLC
General Hospital · 297d
Cleared May 06, 2021
Talent-Pro Electromagnetic Stimulator
K202031 · IPF
Remed Co., Ltd.
Physical Medicine · 288d
Cleared May 06, 2021
KardiFlex NC Coronary Dilatation Catheter
K202578 · LOX
Medcaptain Life Science Co., Ltd.
Cardiovascular · 240d
Cleared May 06, 2021
3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties...
K202598 · FXX
3A Medical Products Co., Ltd.
General Hospital · 240d
Cleared May 06, 2021
DRPx Locking Distal Radius Plate System
K202971 · HRS
Orthopaedic Implant Company
Orthopedic · 218d
Cleared May 06, 2021
CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
K203183 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 191d
Cleared May 06, 2021
CoolSeal Reveal
K203640 · GEI
Bolder Surgical, LLC
General & Plastic Surgery · 143d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 06, 2021
Identity Imprint Knee Replacement System
K210191 · JWH
Conformis, Inc.
Orthopedic · 101d
Cleared May 06, 2021
AutoCap RX
K210353 · ODC
Boston Scientific Corporation
Gastroenterology & Urology · 87d
Cleared May 06, 2021
Dr. Yglo Wart Remover
K210529 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 72d
Cleared May 06, 2021
Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level...
K210705 · FXX
Defender Safety, Inc.
General Hospital · 58d
Cleared May 06, 2021
CONDUIT Instruments
K210728 · MAX
Medos International SARL
Orthopedic · 56d
Cleared May 06, 2021
Corvus Radiation Therapy Planning System
K211034 · MUJ
Best Nomos
Radiology · 29d
Cleared May 05, 2021
Genius / Genuin Total Knee System
K200765 · JWH
Biorad Medisys Pvt, Ltd.
Orthopedic · 407d
Cleared May 05, 2021
D function
K203525 · NUW
Ito Co., Ltd.
Dental · 155d
Cleared May 05, 2021
GR-14 Resin System
K210298 · EBI
Pro3dure Medical GmbH
Dental · 91d
Cleared May 05, 2021
OrthoGold 100
K210451 · ISA
Tissue Regeneration Technologies, LLC
Physical Medicine · 78d
Cleared May 05, 2021
Bose SoundControl Hearing Aids
K211008 · QDD
Bose Corporation
Ear, Nose, Throat · 30d
Cleared May 05, 2021
OIC External Fixation System
K211112 · KTT
Orthopaedic Implant Company
Orthopedic · 21d
Cleared May 04, 2021
Rebellion, Phantom Multi-Bite Kerrison Rongeur 
K200768 · HAE
Morpheus AG
Neurology · 405d
Cleared May 04, 2021
ProntoPump Sterile Tube Set
K200893 · LHI
Ipax, Inc.
General Hospital · 396d
Cleared May 04, 2021
Electric Breast Pump
K201152 · HGX
Guangdong Horigen Mother & Baby...
Obstetrics & Gynecology · 370d