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
6817–6840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2024
Radiance V5
K233236 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 232d
Cleared May 17, 2024
icotec Anterior Cervical Plate System
K233215 · KWQ
Icotec AG
Orthopedic · 234d
Cleared May 17, 2024
uOmnispace.CT
K233209 · QIH
Shanghai United Imaging Healthcare...
Radiology · 232d
Cleared May 17, 2024
Curlin 8000 Ambulatory Infusion System
K232793 · FRN
Zevex, Inc.
General Hospital · 249d
Cleared May 17, 2024
Yoni.Fit Bladder Support
K232525 · HHW
Watkins-Conti Products, Inc.
Gastroenterology & Urology · 270d
Cleared May 17, 2024
Sentec Digital Monitoring System (SDMS) tCOM+
K232516 · LKD
Sentec AG
Anesthesiology · 273d
Cleared May 17, 2024
Kahook Dual Blade Glide (KDB Glide)
K220891 · QUQ
New World Medical, Inc.
Ophthalmic · 781d
Cleared May 16, 2024
ReShape Calibration Tubes (B-2032, B-2036, B-2040)
K241039 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 30d
Cleared May 16, 2024
DEKA TORO
K240752 · GEX
El.En S.P.A.
General & Plastic Surgery · 58d
Cleared May 16, 2024
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae...
K240445 · JWY
Thermo Fisher Scientific
Microbiology · 91d
Cleared May 16, 2024
Picosecond Nd:YAG Laser Systems (BL-C10)
K240386 · GEX
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery · 98d
Cleared May 16, 2024
eXciteOSA without remote control (3000)
K240328 · QNO
Signifier Medical Technologies, Ltd.
Dental · 101d
Cleared May 16, 2024
FAgamin®
K240059 · PHR
Tedequim Srl
Dental · 129d
Cleared May 16, 2024
HD80 Series Ultrasound Diagnostic System
K233841 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 164d
Cleared May 16, 2024
RAYDENT SW
K233625 · PNN
Ray Co., Ltd.
Dental · 185d
Cleared May 16, 2024
DEKA LOTUS
K233473 · ONF
El.En S.P.A.
General & Plastic Surgery · 204d
Cleared May 16, 2024
Ticare Dental Implant Systems
K233137 · DZE
Mozograu S.A.
Dental · 232d
Cleared May 16, 2024
AirKEE P900
K232933 · FRA
Healkee Medical Pte, Ltd.
General Hospital · 239d
Cleared May 16, 2024
Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer...
K232849 · FYC
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 245d
Cleared May 16, 2024
Stimulation System (PA series, PR series, S series and Q series)
K232786 · IPF
Edan Instruments, Inc.
Physical Medicine · 248d
Cleared May 16, 2024
Wedge XL Delivery Catheter
K232542 · QJP
MicroVention, Inc.
Neurology · 268d
Cleared May 16, 2024
Sempulse Halo Vital Signs Monitor
K232495 · DQA
Sempulse Corporation
Anesthesiology · 273d
Cleared May 16, 2024
Pain Therapy Device(Model: P.T.S-X)
K230711 · NGX
Guangzhou Xinbo Electronic Co., Ltd.
Physical Medicine · 428d
Cleared May 15, 2024
BriefCase-Quantification
K241112 · QIH
Aidoc Medical , Ltd.
Radiology · 23d