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
12121–12144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 24, 2022
Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for...
K222294 · LZA
Onetexx Sdn Bhd
General Hospital · 54d
Cleared Sep 24, 2022
Betel Gloves Nitrile Examination Glove Powder Free
K222342 · LZA
Betel Care Sdn. Bhd.
General Hospital · 52d
Cleared Sep 24, 2022
Single-use medical latex examination gloves (LG100)
K222693 · LYY
Fitone Latex Products Co., Ltd....
General Hospital · 18d
Cleared Sep 23, 2022
A.B. Dental Devices Dental Implants System
K202144 · NHA
A.B. Dental Device , Ltd.
Dental · 784d
Cleared Sep 23, 2022
DENU Composite Resin, DENU Flow Resin
K213339 · EBF
Hdi, Inc.
Dental · 351d
Cleared Sep 23, 2022
XACT Robotic System, ACE Model
K213759 · JAK
Xact Robotics, Ltd.
Radiology · 297d
Cleared Sep 23, 2022
Esthetic Colorant
K220369 · EIH
Kuraray Noritake Dental, Inc.
Dental · 227d
Cleared Sep 23, 2022
Platform® Acetabular System
K220483 · LZO
Total Joint Orthopedics, Inc.
Orthopedic · 217d
Cleared Sep 23, 2022
HotDog Temperature Management System
K220941 · DWJ
Augustine Temperature Management
Cardiovascular · 176d
Cleared Sep 23, 2022
NeutrArt
K221481 · FPA
Asset Medikal Tasarim As.
General Hospital · 123d
Cleared Sep 23, 2022
Conductive Gel
K221724 · GYB
Tone-A-Matic International, Inc.
Neurology · 101d