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
7153–7176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2024
Catalyst F1x Shoulder System
K234105 · PHX
Catalyst Orthoscience, Inc.
Orthopedic · 101d
Cleared Apr 05, 2024
DigiLine Direct Print Aligner System
K233935 · NXC
Park Dental Research Corporation
Dental · 113d
Cleared Apr 05, 2024
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C,...
K233779 · EOQ
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 130d
Cleared Apr 05, 2024
CorVista System with PH Add-On
K233666 · SAT
Analytics For Life, Inc.
Cardiovascular · 142d
Cleared Apr 05, 2024
APPRAISE-HRI
K233249 · SAR
The Surgeon General, Department of...
Cardiovascular · 190d
Cleared Apr 05, 2024
Wireless Smart Thermometer
K233192 · FLL
Famidoc Technology Company Limited
General Hospital · 190d
Cleared Apr 05, 2024
Ambu® aScope™ Gastro Large
K232919 · FDS
Ambu A/S
Gastroenterology & Urology · 199d
Cleared Apr 05, 2024
MCG-S (AM1000)
K232823 · DPS
Amcg Co., Ltd.
Cardiovascular · 205d
Cleared Apr 05, 2024
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage,...
K232792 · MAX
Icotec AG
Orthopedic · 207d
Cleared Apr 05, 2024
TDM Large Bone Plate and Screw System
K232115 · HRS
Tdm Co., Ltd.
Orthopedic · 266d
Cleared Apr 05, 2024
Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene®...
K232103 · QKM
Terragene S.A.
General Hospital · 266d
Cleared Apr 05, 2024
ACTIV™ Cap
K223914 · QBP
Cleansite Medical, Inc.
General Hospital · 463d
Cleared Apr 04, 2024
Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06...
K240652 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 28d
Cleared Apr 04, 2024
PINNACLETM Constrained Acetabular Liners
K240639 · KWZ
Depuy Ireland UC
Orthopedic · 29d
Cleared Apr 04, 2024
Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL)
K240361 · LZA
Hebei Titans Hongsen Medical...
General Hospital · 58d
Cleared Apr 04, 2024
Preview Shoulder
K240172 · QIH
Genesis Software Innovations
Radiology · 73d
Cleared Apr 04, 2024
Peleton Universal Single Use Power System and Attachments
K240071 · SAM
Peleton Surgical
Orthopedic · 85d
Cleared Apr 04, 2024
Clear Moves Aligners
K240038 · NXC
Space Maintainers Laboratories (Sml)
Dental · 90d
Cleared Apr 04, 2024
Vertex Hip Fracture Nailing System
K233910 · HSB
Orthoxel Dac
Orthopedic · 114d
Cleared Apr 04, 2024
Agile Esophageal Stent System
K233837 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 122d
Cleared Apr 04, 2024
ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
K233050 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 192d
Cleared Apr 04, 2024
Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer
K233026 · FLE
Midmark Corporation
General Hospital · 195d
Cleared Apr 04, 2024
KONG®-TL VBR System and KONG® C VBR System
K232790 · MQP
Icotec AG
Orthopedic · 206d
Cleared Apr 04, 2024
ABLATE-IQ
K232227 · JAK
Neuwave Medical, Inc.
Radiology · 252d