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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
13345–13368 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2022
PROWLER SELECT LP ES Microcatheter
K214025 · KRA
Medos International SARL
Neurology · 111d
Cleared Apr 12, 2022
ClearPoint Array System (version 1.1)
K214040 · HAW
ClearPoint Neuro, Inc.
Neurology · 110d
Cleared Apr 12, 2022
Safety Blood Collection / Infusion Set (with/without needle holder), Blood...
K214075 · FMI
Anhui Hongyu Wuzhou Medical...
General Hospital · 106d
Cleared Apr 12, 2022
Disposable Surgical Gown
K214088 · FYA
Weihai Hongyu Nonwoven Fabric...
General Hospital · 105d
Cleared Apr 12, 2022
Audion ET dilation system
K220027 · PNZ
Entellus Medical, Inc.
Ear, Nose, Throat · 97d
Cleared Apr 12, 2022
LED Therapy Device (Planar LED/Planar LED mini)
K220103 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Apr 12, 2022
Amis K Long
K220405 · LZO
Medacta International S.A.
Orthopedic · 57d
Cleared Apr 11, 2022
Micro Catheter and Guidewire System
K212719 · KRA
Suzhou Hengrui Hongyuan Medical Co.,...
Cardiovascular · 227d
Cleared Apr 11, 2022
Intense Pulsed Light (IPL) System
K212881 · OHT
Shenzhen Fansizhe Science And...
General & Plastic Surgery · 213d
Cleared Apr 11, 2022
TRELLIS™ SI Joint Fusion System
K212962 · OUR
Orthofundamentals, LLC
Orthopedic · 207d
Cleared Apr 11, 2022
Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with...
K213437 · LZA
Central Medicare Sdn Bhd
General Hospital · 171d
Cleared Apr 11, 2022
MP Reconstruction System
K213675 · LZO
Waldemar Link GmbH & Co. KG
Orthopedic · 140d
Cleared Apr 11, 2022
XO CROSS CORONARY Support Catheter
K214107 · DQY
Transit Scientific, LLC
Cardiovascular · 103d
Cleared Apr 11, 2022
Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black
K220121 · LZA
Aamedix Glove Sdn Bhd
General Hospital · 83d
Cleared Apr 11, 2022
G-EYE System
K220158 · FDF
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 82d
Cleared Apr 11, 2022
Powder Free Nitrile Examination Glove, Non-sterile (Blue)
K220209 · LZA
Ksg Medicare Sdn. Bhd.
General Hospital · 75d
Cleared Apr 11, 2022
Cellvizio 100 series system with confocal Miniprobes
K220477 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 52d
Cleared Apr 11, 2022
World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E...
K220737 · JWH
Signature Orthopaedics Pty, Ltd.
Orthopedic · 28d
Cleared Apr 09, 2022
Nitrile Examination Gloves
K212929 · LZA
Watchtower Ppe Supplies, Inc.
General Hospital · 207d
Cleared Apr 09, 2022
Pink Powder Free Nitrile Examination Glove With Bubblegum Scented,...
K220401 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 57d
Cleared Apr 08, 2022
Oxygen Concentrator
K202389 · CAW
Foshan Mic Medical Technology Co., Ltd.
Anesthesiology · 595d
Cleared Apr 08, 2022
visor2 system
K210109 · HAW
Eemagine Medical Imaging Solutions GmbH
Neurology · 444d
Cleared Apr 08, 2022
Thermeo System
K212017 · MQC
Pro3dure Medical GmbH
Dental · 284d
Cleared Apr 08, 2022
INT Contour
K212274 · MUJ
Carina Medical, LLC
Radiology · 262d