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
3001–3024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 24, 2025
SPY Laparoscope
K252010 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Jul 24, 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU,...
K251984 · OHT
Shenzhen Ulike Smart Electronics Co.,...
General & Plastic Surgery · 27d
Cleared Jul 24, 2025
HemosIL Fibrinogen-C
K251968 · KQJ
Instrumentation Laboratory (IL) Co.
Hematology · 28d
Cleared Jul 24, 2025
Onflex™ Mesh
K251955 · FTL
Davol Inc., Subsidiary of C. R. Bard,...
General & Plastic Surgery · 29d
Cleared Jul 24, 2025
MOTO Partial Knee System Extension
K251618 · HSX
Medacta International S.A.
Orthopedic · 58d
Cleared Jul 24, 2025
EPIQ Series Diagnostic Ultrasound System
K251455 · IYN
Philips Ultrasound, LLC
Radiology · 73d
Cleared Jul 24, 2025
MIS LYNX Conical Connection Implant System
K251297 · DZE
Dentsply Sirona, Inc.
Dental · 87d
Cleared Jul 24, 2025
Respond OC Conserving Regulator (130-0800)
K250322 · NFB
Responsive Respiratory
Anesthesiology · 170d
Cleared Jul 24, 2025
TSK SELECT™ Needle
K250284 · FMI
Tsk Laboratory, Japan
General Hospital · 174d
Cleared Jul 24, 2025
Confocal Microprobe Imaging System (BrightP980)
K243711 · OWN
Wuxi Hisky Medical Technologies Co.,...
General & Plastic Surgery · 234d
Cleared Jul 24, 2025
Infusomat® Space Volumetric Infusion Pump Administration Sets
K243392 · FPA
B.Braun Medical, Inc.
General Hospital · 266d
Cleared Jul 23, 2025
MammoSTAR Biopsy Site Identifier
K251748 · NEU
Carbon Medical Technologies, Inc.
General & Plastic Surgery · 47d
Cleared Jul 23, 2025
DESS® Dental Implants
K251280 · DZE
Terrats Medical SL
Dental · 90d
Cleared Jul 23, 2025
Resilience Fully Covered Esophageal Stent System
K251265 · ESW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 23, 2025
Da Vinci Surgical System (IS5000)
K251213 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 96d
Cleared Jul 23, 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the...
K251073 · OLO
Innovasis, Inc.
Orthopedic · 106d
Cleared Jul 23, 2025
IMAGE ONE
K250716 · LLZ
Infomed Software, S.L.
Radiology · 135d
Cleared Jul 23, 2025
MAGiC Sweep™ EP Mapping Catheter
K250590 · DRF
Stereotaxis, Inc.
Cardiovascular · 146d
Cleared Jul 23, 2025
SD TL Implant System
K250280 · DZE
Arum Dentistry Co., Ltd.
Dental · 173d
Cleared Jul 23, 2025
HemoSphere Advanced Monitor (HEM1)
K243781 · DQK
Edwards Lifesciences
Cardiovascular · 226d
Cleared Jul 23, 2025
Neuro Insight V1.0
K243681 · LLZ
Olea Medical S.A.S.
Radiology · 236d
Cleared Jul 23, 2025
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer...
K243373 · MQF
Vitrolife Sweden AB
Obstetrics & Gynecology · 266d
Cleared Jul 23, 2025
Intermittent pressure compression system (Compression Pump PT1005A
K242615 · IRP
Xiamen Taotao Technology Co., Ltd.
Physical Medicine · 323d
Cleared Jul 22, 2025
Mobility Scooter (MS160C)
K251638 · INI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 54d