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
5593–5616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 09, 2024
eMVFit (MVF-10M)
K240991 · PBX
Weero Co., Ltd.
General & Plastic Surgery · 181d
Cleared Oct 09, 2024
Clavicle and Scapula System
K240181 · HRS
Auxein Medical Pvt., Ltd.
Orthopedic · 260d
Cleared Oct 09, 2024
CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)
K240095 · LRX
Shanghai Care US Medical Product Co.,...
Ophthalmic · 271d
Cleared Oct 09, 2024
MEDIYAG
K231948 · GEX
Medicreations, LLC
General & Plastic Surgery · 467d
Cleared Oct 08, 2024
ProLift Wedge Expandable Spacer System
K242826 · MAX
Life Spine, Inc.
Orthopedic · 20d
Cleared Oct 08, 2024
Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K242391 · LPL
Lucens Technology Co., Ltd.
Ophthalmic · 57d
Cleared Oct 08, 2024
Gemini Medical Cage System
K242267 · MAX
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 68d
Cleared Oct 08, 2024
Jet Flow Bulk
K242014 · EBF
Meta Biomed Co., Ltd.
Dental · 90d
Cleared Oct 08, 2024
Nerivio
K241756 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 112d
Cleared Oct 08, 2024
Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)
K241446 · IRP
Sichuan Qianii-Beoka Medical...
Physical Medicine · 139d
Cleared Oct 08, 2024
Sejoy Blood Glucose Monitoring System
K240640 · NBW
Sejoy Biomedical Co., Ltd.
Chemistry · 216d
Cleared Oct 08, 2024
Power Wheelchair (JJW-6001)
K240563 · ITI
ZheJiang J&J Mobility Co., Ltd.
Physical Medicine · 222d
Cleared Oct 08, 2024
TROJAN SIS Synthetic Latex Condom with Silicone Lubricant
K240379 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 244d
Cleared Oct 08, 2024
Single-use Ureteral Access Sheath
K240167 · FED
Hunan Vathin Medical Instrument Co.,...
Gastroenterology & Urology · 260d
Cleared Oct 07, 2024
OvertureTi Knee Resurfacing SystemTM
K242746 · HSX
Overture Orthopaedics
Orthopedic · 26d
Cleared Oct 07, 2024
DEKA Infusion System, DEKA Administration Set
K242693 · LDR
Deka Research and Development...
General Hospital · 28d
Cleared Oct 07, 2024
EARP Interbody System
K242457 · MAX
Retropsoas Technologies, LLC
Orthopedic · 49d
Cleared Oct 07, 2024
OR3O Dual Mobility System
K242375 · LPH
Smith & Nephew, Inc.
Orthopedic · 59d
Cleared Oct 07, 2024
Water Container (MAJ-901)
K242357 · OCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 60d
Cleared Oct 07, 2024
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
K242208 · FRG
Primed Medical Products, Inc.
General Hospital · 70d
Cleared Oct 07, 2024
SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141)
K242152 · MEB
Epic Medical Pte. , Ltd.
General Hospital · 76d
Cleared Oct 07, 2024
EMPHASYS Acetabular Shell with RapiTite HA
K242084 · LPH
Depuy Ireland UC
Orthopedic · 83d
Cleared Oct 07, 2024
SpineUs™ System
K241029 · IYO
Verdure Imaging
Radiology · 175d
Cleared Oct 07, 2024
EPIQ Series Diagnostic Ultrasound System
K240980 · IYN
Philips Ultrasound, LLC
Radiology · 180d