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
6961–6984 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 2024
SmarTooth
K231722 · NBL
Smartooth Co., Ltd.
Dental · 323d
Cleared Apr 30, 2024
Morpheus® Moldable
K240621 · MQV
Biogennix, LLC
Orthopedic · 56d
Cleared Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical...
K240156 · DSA
Physio-Control, Inc.
Cardiovascular · 102d
Cleared Apr 30, 2024
Picosecond Nd:YAG Laser System
K240118 · GEX
Smedtrum Medical Technology Co., Ltd.
General & Plastic Surgery · 105d
Cleared Apr 30, 2024
Flexset System
K233403 · GWQ
Zeto, Inc.
Neurology · 209d
Cleared Apr 30, 2024
Dental Implants and Abutments
K233231 · DZE
Ditron Dental, Ltd.
Dental · 215d
Cleared Apr 30, 2024
High Speed Air Turbine Handpiece...
K233122 · EFB
Litu Tech , Ltd.
Dental · 216d
Cleared Apr 30, 2024
Ethos Treatment Management (3.0)
K232923 · IYE
Varian Medical Systems, Inc.
Radiology · 224d
Cleared Apr 30, 2024
METICULY Patient-specific titanium maxillofacial mesh implant
K232889 · JEY
Meticuly Co., Ltd.
Dental · 225d
Cleared Apr 30, 2024
Protective Cap
K232528 · NHA
Neobiotech Co., Ltd.
Dental · 253d
Cleared Apr 29, 2024
restor3d Kinos Axiom Total Ankle System
K240591 · HSN
Restor3D, Inc.
Orthopedic · 59d
Cleared Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
K240584 · CAC
Sorin Group Italia S.R.L.
Cardiovascular · 59d
Cleared Apr 29, 2024
DuraPro™ Oscillating System
K240568 · OLO
Globus Medical, Inc.
Orthopedic · 60d
Cleared Apr 29, 2024
POWEReam Xia/Serrato
K240526 · NKB
Stryker Instruments
Orthopedic · 66d
Cleared Apr 29, 2024
Volnewmer™
K240248 · GEI
Classys, Inc.
General & Plastic Surgery · 90d
Cleared Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
K240102 · DXN
Guangdong Transtek Medical...
Cardiovascular · 104d
Cleared Apr 29, 2024
ARVIS® Shoulder
K240062 · OLO
Insight Medical Systems, Inc.
Orthopedic · 111d
Cleared Apr 29, 2024
Ultraflex Esophageal NG Stent System
K233939 · ESW
Boston Scientific
Gastroenterology & Urology · 137d
Cleared Apr 29, 2024
SubtleREFORMAT (1.x)
K233699 · LLZ
Subtle Medical, Inc.
Radiology · 164d
Cleared Apr 29, 2024
Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)
K232511 · NUJ
Surgical Instrument Service and...
General & Plastic Surgery · 255d
Cleared Apr 26, 2024
EsophyX Z+ Device with SerosaFuse Fasteners and Accessories
K240879 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 2024
Erisma® Deformity Spinal System
K240872 · NKB
Clariance
Orthopedic · 28d
Cleared Apr 26, 2024
Reef L Interbody System
K240566 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 57d
Cleared Apr 26, 2024
Sonio Detect
K240406 · IYN
Sonio
Radiology · 77d