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
10561–10584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 2023
Tryptik Ti
K230583 · ODP
Spineart SA
Orthopedic · 20d
Cleared Mar 21, 2023
OviTex PRS (Long Term Resorbable)
K214070 · FTM
Tela Bio
General & Plastic Surgery · 449d
Cleared Mar 21, 2023
Genomadix Cube CYP2C19 System
K220026 · NTI
Genomadix, Inc.
Toxicology · 440d
Cleared Mar 21, 2023
EasyTouch Lancing Device
K222617 · QRK
Stat Medical Devices
General & Plastic Surgery · 203d
Cleared Mar 21, 2023
Retraction, CWM-910T, APOLEX Tite
K222709 · GEI
Chungwoo Co., Ltd.
General & Plastic Surgery · 194d
Cleared Mar 21, 2023
FlightPlan for Embolization
K223490 · LLZ
GE Medical Systems SCS
Radiology · 120d
Cleared Mar 21, 2023
Instrument Case P1340904
K223672 · KCT
Cochlear
General Hospital · 104d
Cleared Mar 21, 2023
Entasis 3D Dual-Lead Sacroiliac Implant System
K223708 · OUR
Corelink, LLC
Orthopedic · 99d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or...
K223844 · JWY
Thermo Fisher Scientific
Microbiology · 89d
Cleared Mar 21, 2023
DSM Biomedical Calcium Phosphate Cement
K230054 · MQV
Dsm Biomedical
Orthopedic · 74d
Cleared Mar 21, 2023
LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface
K230471 · JWH
Waldemar Link GmbH & Co. KG
Orthopedic · 28d
Cleared Mar 21, 2023
Nio Color 2MP (MDNC-2521)
K230520 · PGY
Barco N.V.
Radiology · 22d
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Mar 20, 2023
HPR45i
K220725 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 371d
Cleared Mar 20, 2023
P-Cure Proton Beam Therapy System
K221996 · LHN
P-Cure, Ltd.
Radiology · 257d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 20, 2023
Shina Safety Needle
K222417 · FMI
Shina Corporation
General Hospital · 222d
Cleared Mar 20, 2023
Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B,...
K222828 · GCJ
Wickimed (Huizhou) Medical Equipment...
General & Plastic Surgery · 182d
Cleared Mar 20, 2023
The Integrity Spine Core System
K223043 · ODP
Integrity Spine
Orthopedic · 179d
Cleared Mar 20, 2023
Colibrí
K223245 · QQV
Copan Wasp Srl
Microbiology · 151d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875 · LNH
Sino Canada Health Engineering...
Radiology · 87d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230163 · NUH
Changsha Yuwen Medical Equipment Co.,...
Physical Medicine · 59d
Cleared Mar 20, 2023
TENS and EMS Stimulation (OTC)
K230174 · NUH
Changsha Yuwen Medical Equipment Co.,...
Physical Medicine · 59d
Cleared Mar 18, 2023
InterOss Collagen
K221808 · NPM
Sigmagraft, Inc.
Dental · 269d