FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
817–840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 06, 2026
Polyethylene
K260775 · GAT
Teleflex Medical, LLC
General & Plastic Surgery · 57d
Cleared May 06, 2026
YP-710T Series NIBP Cuff
K260747 · DXQ
Nihon Kohden Corporation
Cardiovascular · 61d
Cleared May 06, 2026
Denture Base
K260376 · EBI
Shandong Huge Dental Material...
Dental · 90d
Cleared May 06, 2026
KardiaPSI Balloon Catheter
K253855 · OZT
Intervention Tech, Inc. ; dba Corvention
Cardiovascular · 154d
Cleared May 06, 2026
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
K253152 · DXN
Biozen, LLC
Cardiovascular · 222d
Cleared May 06, 2026
Anchor with Fiber Wire and Disposable Inserter
K253027 · MBI
Ortobio S.A.
Orthopedic · 229d
Cleared May 06, 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
K252552 · KPI
Shenzhen Changkun Technology Co., Ltd.
Gastroenterology & Urology · 266d
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