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

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175,820 results
17833–17856 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2021
SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System
K201967 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
K201968 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d
Cleared Feb 26, 2021
imani i1
K202045 · HGX
Imani Co.
Obstetrics & Gynecology · 218d
Cleared Feb 26, 2021
Medical infrared forehead thermometer
K202111 · FLL
Hunan Honggao Electronic Technolofy...
General Hospital · 211d
Cleared Feb 26, 2021
Brite Tip Radianz Guiding Sheath
K202167 · DYB
Cordis Corporation
Cardiovascular · 207d
Cleared Feb 26, 2021
Solax Electric Scooter (Model: S202261B)
K202549 · INI
Dongguan Prestige Sporting Goods Co.,...
Physical Medicine · 176d
Cleared Feb 26, 2021
FLARE Single-Use Surgical Laser Fiber
K202702 · GEX
Realton (Suzhou) Medical Technology...
General & Plastic Surgery · 163d
Cleared Feb 26, 2021
Erisma LP Navigated Instruments
K202956 · OLO
Clariance, Sas
Orthopedic · 149d
Cleared Feb 26, 2021
Spectral CT
K203020 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Feb 26, 2021
SubtleMR
K203182 · LLZ
Subtle Medical, Inc.
Radiology · 122d
Cleared Feb 26, 2021
Disposable Vinyl Examination Gloves
K203439 · LYZ
Shandong Zhushi Pharmaceutical Group...
General Hospital · 95d
Cleared Feb 26, 2021
IPL Hair removal
K203510 · OHT
Shenzhen Weikai Technology Co.,Ltd
General & Plastic Surgery · 88d
Cleared Feb 26, 2021
Cuptimize
K203651 · LLZ
Cuptimize, Inc.
Radiology · 74d
Cleared Feb 26, 2021
T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF...
K203819 · HSB
Stryker GmbH
Orthopedic · 59d
Cleared Feb 26, 2021
Laser Treatment System, Model: NYX and Grace
K210033 · GEX
Canadian Pioneer Medical Technology...
General & Plastic Surgery · 52d
Cleared Feb 26, 2021
LTJ Screws and Washer
K210268 · HWC
Azurmeds, Inc.
Orthopedic · 25d
Cleared Feb 26, 2021
Indigo Aspiration System - Lightning Aspiration Tubing
K210323 · QEW
Penumbra, Inc.
Cardiovascular · 22d
Cleared Feb 25, 2021
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE,...
K201142 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 302d
Cleared Feb 25, 2021
Vortek Single Loop Ureteral Stent
K201436 · FAD
Coloplast Corp.
Gastroenterology & Urology · 269d
Cleared Feb 25, 2021
KARL STORZ UDEL Sterilization Trays
K201945 · KCT
KARL STORZ Endoscopy-America, Inc.
General Hospital · 227d
Cleared Feb 25, 2021
SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System
K201969 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 25, 2021
SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System
K201971 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 225d
Cleared Feb 25, 2021
Disposable Surgical Mask/Fluid Resistant Procedure Mask
K202240 · FXX
Lhm Medical Technology (Hong Kong)...
General Hospital · 199d
Cleared Feb 25, 2021
Infrared Forehead Thermometer
K202420 · FLL
Conmo Electronic Company Limited
General Hospital · 185d