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: 2026–2026 ×
1,642 results
553–576 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 05, 2026
Healium Intelliscan LX192LC
K261132 · IYN
Healium Intelliscan Corporation
Radiology · 29d
Cleared May 05, 2026
AccelFix Spinal Fixation System
K261130 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 29d
Cleared May 05, 2026
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP,...
K260742 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 60d
Cleared May 05, 2026
MectaLIF 3D Metal Anterior
K254202 · OVD
Medacta International S.A.
Orthopedic · 127d
Cleared May 05, 2026
Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1,...
K254200 · IRP
Wenzhou Lingfeng Electronic...
Physical Medicine · 127d
Cleared May 05, 2026
Lumify Diagnostic Ultrasound System
K252558 · IYN
Philips Ultrasound, LLC
Radiology · 265d
Cleared May 04, 2026
Neowise
K260716 · LLZ
Cefla S.C.
Radiology · 60d
Cleared May 04, 2026
Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)
K260688 · OLI
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 62d
Cleared May 04, 2026
Q-Switched Nd: YAG Laser Systems
K260256 · GEX
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 96d
Cleared May 04, 2026
ArteraAI Breast
K254115 · SHW
Artera, Inc.
Pathology · 136d
Cleared May 04, 2026
Wound Geni NPWT System
K254019 · OMP
Bechtel Medical, Inc.
General & Plastic Surgery · 140d
Cleared May 04, 2026
Leaseir MHR Xcell (console) (MHR-100b)
K253251 · GEX
Leaseir Technologies, Slu
General & Plastic Surgery · 217d
Cleared May 04, 2026
MammoSightAI
K252954 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 230d
Cleared May 04, 2026
Male Latex Condom HA
K252622 · HIS
Okamoto USA, Inc.
Obstetrics & Gynecology · 258d
Cleared May 04, 2026
AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P,...
K252543 · FPA
Amsino International, Inc.
General Hospital · 265d
Cleared May 01, 2026
BIOMONITOR IV (471155)
K261074 · MXD
Biotronik, Inc.
Cardiovascular · 30d
Cleared May 01, 2026
Verifine Safety Lancets
K261045 · FMK
Promisemed Hangzhou Meditech Co., Ltd.
General & Plastic Surgery · 31d
Cleared May 01, 2026
EndoTool IV Cloud 1.0
K260910 · NDC
Glooko, Inc.
Chemistry · 43d
Cleared May 01, 2026
Any-Com Seal
K260819 · EBC
Mediclus Co., Ltd.
Dental · 49d
Cleared May 01, 2026
Ancora-SB
K260314 · FDA
Aspero Medical, Inc.
Gastroenterology & Urology · 91d
Cleared May 01, 2026
Phototherapy System (DUV-COMBO)
K254234 · FTC
Choyang Medics Co., Ltd.
General & Plastic Surgery · 123d
Cleared May 01, 2026
FX V135 EASYTECH® Shoulder System
K254154 · PKC
FX Shoulder Solutions, Inc.
Orthopedic · 130d
Cleared May 01, 2026
BioCode® Respiratory Pathogen Panel (RPP)
K254139 · OCC
Applied BioCode, Inc.
Microbiology · 130d
Cleared May 01, 2026
OSSIOfiber® Threaded Trimmable Fixation Nail
K254077 · HWC
OSSIO , Ltd.
Orthopedic · 134d