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
12937–12960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 2022
T3 Platform Software
K213230 · PPW
Etiometry, Inc.
Cardiovascular · 266d
Cleared Jun 22, 2022
Qlicksmart BladeFlask UNIVERSAL
K213274 · MMK
Qlicksmart Pty , Ltd.
General Hospital · 265d
Cleared Jun 22, 2022
GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
K213283 · GBM
Convatec Limited
Gastroenterology & Urology · 264d
Cleared Jun 22, 2022
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced,...
K213345 · EWO
Path Medical GmbH
Ear, Nose, Throat · 257d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry...
K213682 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 212d
Cleared Jun 22, 2022
Nitrile Examination Gloves
K213739 · LZA
Hangzhou Runheng Medical Co., Ltd.
General Hospital · 205d
Cleared Jun 22, 2022
Glidewell 3DP Denture Base Resin
K213765 · EBI
Prismatik Dentalcraft, Inc.
Dental · 203d
Cleared Jun 22, 2022
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K220413 · QPP
Canary Medical USA, LLC
Orthopedic · 128d
Cleared Jun 22, 2022
Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex...
K220586 · FTL
Sofradim Production
General & Plastic Surgery · 113d
Cleared Jun 22, 2022
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
K221008 · MUH
Shanghai Handy Medical Equipment Co.,...
Radiology · 78d
Cleared Jun 22, 2022
TC Gloves
K221185 · LYY
Thanh Cong Pharmaceutical and Trading...
General Hospital · 58d
Cleared Jun 22, 2022
Disposable Nitrile Powder-Free Examination Gloves
K221192 · LZA
Shandong Maida Medical Technology...
General Hospital · 58d
Cleared Jun 22, 2022
Esophageal TTS Stent
K221482 · ESW
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 30d
Cleared Jun 21, 2022
Stainless Turbine
K203791 · EFB
Nakanishi, Inc.
Dental · 540d
Cleared Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · MTD
Acutus Medical, Inc.
Cardiovascular · 463d
Cleared Jun 21, 2022
CORE-Trocar
K211148 · GCJ
Incore Co., Ltd.
General & Plastic Surgery · 428d
Cleared Jun 21, 2022
Lumenis Y&R Laser System
K211979 · GEX
Lumenis, Inc.
General & Plastic Surgery · 361d
Cleared Jun 21, 2022
Revaree Plus Vaginal Suppositories
K213220 · NUC
Farma-Derma S.R.L.
Obstetrics & Gynecology · 265d
Cleared Jun 21, 2022
Syngo Carbon Space VA20A
K213665 · LLZ
Siemens Healthcare GmbH
Radiology · 211d
Cleared Jun 21, 2022
Aspirex Thrombectomy System
K220270 · QEW
C.R. Bard, Inc.
Cardiovascular · 141d
Cleared Jun 21, 2022
NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0...
K220478 · MAX
Nu Vasive, Incorporated
Orthopedic · 123d
Cleared Jun 21, 2022
Sherlock
K220482 · NHA
Open Implants, LLC
Dental · 123d
Cleared Jun 21, 2022
Venue Go
K220800 · IYN
GE Medical Systems Ultrasound and...
Radiology · 95d
Cleared Jun 21, 2022
Vial Adapter Ø13mm
K220856 · LHI
Avenir Performance Europ?enne Medical...
General Hospital · 90d