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
11929–11952 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 14, 2022
Tornier Perform Humeral System – Fracture
K220914 · PHX
Tornier, Inc.
Orthopedic · 198d
Cleared Oct 14, 2022
Shoulder PacemakerTM
K220994 · IPF
Ncs Lab Srl
Physical Medicine · 193d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 184d
Cleared Oct 14, 2022
FOCUS Interbody System
K221172 · MAX
Oc Medical Devices
Orthopedic · 172d
Cleared Oct 14, 2022
AI-Rad Companion Organs RT
K221305 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 162d
Cleared Oct 14, 2022
Southern Anterior Screw Fixated Cage (SASCA)
K221447 · OVD
Southern Medical (Pty) , Ltd.
Orthopedic · 149d
Cleared Oct 14, 2022
syngo.via View&GO
K221501 · LLZ
Siemens Healthcare GmbH
Radiology · 144d
Cleared Oct 14, 2022
BD Surgiphor™ Antimicrobial Irrigation System
K221504 · FQH
Bd
General & Plastic Surgery · 144d
Cleared Oct 14, 2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840 · JXG
Integra Lifesciences Production...
Neurology · 112d
Cleared Oct 14, 2022
ZSFab Lumbar Interbody System
K221858 · MAX
Zsfab, Inc.
Orthopedic · 109d
Cleared Oct 14, 2022
Sublime Microcatheter
K221886 · DQY
Surmodics,Inc.
Cardiovascular · 107d
Cleared Oct 14, 2022
Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
K222284 · GEI
Applied Medical Resources Corporation
General & Plastic Surgery · 74d
Cleared Oct 14, 2022
16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast...
K222407 · MOS
Neocoil, LLC
Radiology · 66d
Cleared Oct 14, 2022
IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi
K222537 · OHT
Shenzhen Ishine Technology Company...
General & Plastic Surgery · 53d
Cleared Oct 14, 2022
Vitrea CT Cardiac Analysis
K222662 · LLZ
Canon Medical Informatics, Inc.
Radiology · 42d
Cleared Oct 14, 2022
X-Pac Expandable Lumbar Cage System
K222797 · MAX
Expanding Innovations, Inc.
Orthopedic · 28d
Cleared Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 531d
Cleared Oct 13, 2022
CREOKORREKT Aligners
K211427 · NXC
Creodent Prosthetics, Ltd.
Dental · 524d
Cleared Oct 13, 2022
IM/ST Fixture System
K212702 · DZE
Guilin Fiteeth Medical Instrument...
Dental · 413d
Cleared Oct 13, 2022
SPIFE A1AT kit
K213396 · OBZ
Helena Laboratories, Corp.
Immunology · 360d
Cleared Oct 13, 2022
allFlex Ureteral Catheters, Krait Ureteral Catheters
K220730 · KOD
Allwin Medical Devices, Inc.
Gastroenterology & Urology · 213d
Cleared Oct 13, 2022
VITEK 2 AST-Gram Positive Cefoxitin Screen
K220805 · LON
bioMerieux, Inc.
Microbiology · 209d
Cleared Oct 13, 2022
PicoWay Laser System
K220853 · GEX
Candela Corporation
General & Plastic Surgery · 204d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 204d