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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
14257–14280 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K203741 · JWY
Thermo Fisher Scientific
Microbiology · 363d
Cleared Dec 20, 2021
IPL Home Use Hair Removal Device
K211185 · OHT
Shenzhen Beauty Every Moment...
General & Plastic Surgery · 244d
Cleared Dec 20, 2021
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit:...
K211521 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 217d
Cleared Dec 20, 2021
Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile)
K211750 · FXX
National Bridge Industrial (S.Z.)...
General Hospital · 196d
Cleared Dec 20, 2021
Servator M SALF Solution
K211842 · KDL
S.A.L.F. Spa
Gastroenterology & Urology · 188d
Cleared Dec 20, 2021
AdVance XP Male Sling System
K211847 · OTM
Boston Scientific Corporation
Gastroenterology & Urology · 188d
Cleared Dec 20, 2021
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
K211865 · LYZ
Liao Ning Shangwei Medical Products...
General Hospital · 187d
Cleared Dec 20, 2021
Frax 1940 for Nordlys and Frax Pro
K212492 · GEX
Candela Corporation
General & Plastic Surgery · 133d
Cleared Dec 20, 2021
Vy Spine ClariVy Cervical IBF System
K212715 · ODP
Vy Spine, LLC
Orthopedic · 116d
Cleared Dec 20, 2021
Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled
K212776 · NLG
Innovative Health, LLC
Cardiovascular · 110d
Cleared Dec 20, 2021
First Relief
K212859 · NHI
Dyansys, Inc.
Neurology · 103d
Cleared Dec 20, 2021
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat...
K213031 · NCX
Zoll Circulation, Inc.
Neurology · 90d
Cleared Dec 20, 2021
AspenMed+
K213076 · LZC
Aspen Glove Sdn. Bhd.
General Hospital · 88d
Cleared Dec 20, 2021
EchoGo Core (2.0)
K213275 · QIH
Ultromics Limited
Radiology · 81d
Cleared Dec 20, 2021
TR BAND Radial Compression Device
K213531 · DXC
Terumo Medical Corporation
Cardiovascular · 45d
Cleared Dec 19, 2021
ATOZ Mini-Screw
K210559 · OAT
Mk Meditech, Inc.
Dental · 297d
Cleared Dec 18, 2021
Powder Free Nitrile Examination Gloves (Blue, Black, Indigo)
K211457 · LZA
Ammex Corporation
General Hospital · 221d
Cleared Dec 18, 2021
USA Gloves Nitrile Powder Free Exam Gloves
K211624 · LZA
Usa Gloves
General Hospital · 205d
Cleared Dec 18, 2021
Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace...
K212932 · KCT
Nobel Biocare Services AG
General Hospital · 94d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213048 · LZA
Huayuan Medical Technology(Shangqiu)...
General Hospital · 87d
Cleared Dec 18, 2021
Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs)
K213051 · LZA
Yunnan Huazhiyuan Medical Technology...
General Hospital · 87d
Cleared Dec 17, 2021
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and...
K193081 · QEP
Rheonix, Inc.
Microbiology · 773d
Cleared Dec 17, 2021
Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System
K200943 · FLL
Circa Scientific, LLC
Cardiovascular · 618d
Cleared Dec 17, 2021
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood...
K203424 · DTZ
Qura S.R.L
Cardiovascular · 392d