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
4657–4680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 21, 2025
Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011)
K241443 · NUC
Hathor Professional Skincare , Ltd.
Obstetrics & Gynecology · 244d
Cleared Jan 19, 2025
Neonav ECG Tip Location System
K241910 · LJS
Navi Medical Technologies
Cardiovascular · 202d
Cleared Jan 17, 2025
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit...
K243941 · LJS
Access Vascular, Inc.
General Hospital · 28d
Cleared Jan 17, 2025
Aptima CMV Quant Assay
K243935 · PAB
Hologic, Inc.
Microbiology · 28d
Cleared Jan 17, 2025
Affera Integrated Mapping System
K243892 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2025
Mastergraft Matrix EXT
K243706 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Jan 17, 2025
Babyroo TN300
K243606 · FMT
Draeger Medical Systems, Inc.
General Hospital · 57d
Cleared Jan 17, 2025
Aurora
K243605 · KPS
Ge Medical Systems Israel, Functional...
Radiology · 57d
Cleared Jan 17, 2025
Teslatome Bipolar Sphincterotome
K243568 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 60d
Cleared Jan 17, 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name:...
K243545 · DSA
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 63d
Cleared Jan 17, 2025
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
K243502 · IYN
Olympus Medical Systems Corporation
Radiology · 66d
Cleared Jan 17, 2025
ProGrip™ Self-Gripping Polypropylene Mesh
K243315 · FTL
Sofradim Production
General & Plastic Surgery · 87d
Cleared Jan 17, 2025
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
K243291 · HGP
Neoventa Medical AB
Obstetrics & Gynecology · 91d
Cleared Jan 17, 2025
TriALTIS™ Spine System
K243249 · NKB
Medos International SARL
Orthopedic · 98d
Cleared Jan 17, 2025
TBS iNsight (V4)
K243218 · KGI
Medimaps Group SA
Radiology · 105d
Cleared Jan 17, 2025
The ETHICON™ Total Energy System
K243067 · GEI
Ethicon Endo-Surgery, LLC (A Johnson...
General & Plastic Surgery · 112d
Cleared Jan 17, 2025
Type 5 Integrating Indicator for Steam (CSPN-15)
K242860 · JOJ
True Indicating, LLC
General Hospital · 119d
Cleared Jan 17, 2025
Prenuvo Body Composition
K242825 · LNH
Prenuvo
Radiology · 121d
Cleared Jan 17, 2025
Electronic Apex Locator (Alpha Apex I)
K242765 · LQY
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
Dental · 126d
Cleared Jan 17, 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline...
K242705 · LDF
Medtronic, Inc.
Cardiovascular · 130d
Cleared Jan 17, 2025
Embozene Color-Advanced Microspheres
K242608 · KRD
Varian Medical Systems, Inc.
Gastroenterology & Urology · 136d
Cleared Jan 17, 2025
ULSPIRA TS™ Nitric Oxide Therapy System
K242374 · MRN
Airgas Therapeutics, LLC
Anesthesiology · 161d
Cleared Jan 17, 2025
hygh-tec Drainage II
K242336 · KNT
Amb Medtec
Gastroenterology & Urology · 163d
Cleared Jan 17, 2025
TechCare Trauma
K242171 · QBS
Milvue
Radiology · 177d