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
12097–12120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 2022
InnovaMatrix PD
K211902 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 464d
Cleared Sep 28, 2022
Neteera 130H/131H Vital Sign Monitoring Sensor
K212143 · DRT
Neteera Technologies , Ltd.
Cardiovascular · 446d
Cleared Sep 28, 2022
CORE-SPORT
K220081 · OTJ
Incore Co., Ltd.
General & Plastic Surgery · 261d
Cleared Sep 28, 2022
Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)
K220245 · KNG
Contec Medical Systems Co.,Ltd
Obstetrics & Gynecology · 243d
Cleared Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
K221397 · DRA
Abbott Medical
Cardiovascular · 138d
Cleared Sep 28, 2022
Dental Air Polishing Handpiece
K221548 · EFB
Guilin Woodpecker Medical Instrument...
Dental · 124d
Cleared Sep 28, 2022
TROJAN Fire & Ice lubricated male natural rubber latex condom
K221906 · HIS
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 90d
Cleared Sep 28, 2022
IPL Hair Removal Device
K222316 · OHT
Shenzhen Goodwind Technology...
General & Plastic Surgery · 57d
Cleared Sep 28, 2022
SteriCUBE® Multiple Tray Sterilization Systems
K222328 · KCT
Stericube, LLC
General Hospital · 57d
Cleared Sep 28, 2022
BriefCase
K222329 · QAS
Aidoc Medical , Ltd.
Radiology · 57d
Cleared Sep 28, 2022
DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue)
K222442 · LYZ
Anhui Bytech Medical Supplies Co., Ltd.
General Hospital · 47d
Cleared Sep 28, 2022
AGILON XO Shoulder System
K222482 · KWT
Implantcast GmbH
Orthopedic · 42d
Cleared Sep 28, 2022
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid...
K222615 · MED
STERIS Corporation
General Hospital · 29d
Cleared Sep 28, 2022
EndoGI S-Path Biliary Stent System
K222627 · FGE
Endo GI Medical
Gastroenterology & Urology · 28d
Cleared Sep 27, 2022
MTX-C1
K212561 · GEI
Ilooda Co,., Ltd.
General & Plastic Surgery · 410d
Cleared Sep 27, 2022
NanoZoomer S360MD Slide scanner system
K213883 · PSY
Hamamatsu Photonics K.K.
Pathology · 288d
Cleared Sep 27, 2022
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
K220342 · OWB
Canon Medical Systems Corporation
Radiology · 232d
Cleared Sep 27, 2022
Clean Connecting Tube
K220785 · OCX
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 194d
Cleared Sep 27, 2022
Dental Implantation Systems, Dental Electrical Motors
K220831 · EBW
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 189d
Cleared Sep 27, 2022
Infrared thermometer
K221211 · FLL
Shenzhen Yolanda Technology Co., Ltd.
General Hospital · 153d
Cleared Sep 27, 2022
Medline UNITE® Medial Malleolus Peg Plate System
K221360 · HRS
Medline Industries, LP
Orthopedic · 139d
Cleared Sep 27, 2022
NS-HGlio
K221738 · QIH
Neosoma, Inc.
Radiology · 104d
Cleared Sep 27, 2022
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound...
K222648 · IYN
Philips Ultrasound, LLC
Radiology · 26d
Cleared Sep 27, 2022
Digital Radiography CXDI-CS01
K222661 · MQB
Canon, Inc.
Radiology · 25d