FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12385–12408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 26, 2022
Palm NRG cellulite body device (model: Palm NRG body device)
K214015 · PBX
Heat IN A Click, LLC
General & Plastic Surgery · 278d
Cleared Sep 26, 2022
Auryon Atherectomy Catheters
K220116 · MCW
Eximo Medical, Ltd.
Cardiovascular · 255d
Cleared Sep 26, 2022
QT ECG
K220795 · DXH
QT Medical, Inc.
Cardiovascular · 192d
Cleared Sep 26, 2022
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device
K221062 · QRL
Bionime Corporation
General & Plastic Surgery · 168d
Cleared Sep 26, 2022
Flowart
K221473 · FPA
Asset Medikal Tasarim As.
General Hospital · 129d
Cleared Sep 26, 2022
Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation...
K221631 · EOQ
Olympus Medical Systems Corp.
Ear, Nose, Throat · 112d
Cleared Sep 26, 2022
Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)
K222266 · FXX
Jingzhou Haixin Green Cross Medical...
General Hospital · 60d
Cleared Sep 26, 2022
Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video...
K222602 · FAJ
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 28d
Cleared Sep 26, 2022
OtoSight Middle Ear Scope
K222655 · QJG
Photonicare, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 25, 2022
Resonic Rapid Acoustic Pulse Device
K222629 · GEX
Zeltiq Aesthetics, Inc.
General & Plastic Surgery · 25d
Cleared Sep 24, 2022
Powder Free Nitrile Examination Glove
K212751 · LZA
Dainam Glove Joint Stock Company
General Hospital · 390d
Cleared Sep 24, 2022
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy...
K221718 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 103d
Cleared Sep 24, 2022
Nitrile Examination Glove, Pink Color
K221887 · LZA
Guangdong Kingfa Sci. & Tech.Co., Ltd.
General Hospital · 87d