FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
14449–14472 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 08, 2022
Non-sterile, Powder-Free Latex Examination Glove
K212309 · LYY
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared CT Apr 08, 2022
Fitbit Irregular Rhythm Notifications
K212372 · QDB
Fitbit, Inc.
Cardiovascular · 252d
Cleared Apr 08, 2022
SCOUT BX Delivery System
K212882 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 210d
Cleared Apr 08, 2022
DORA Disposable A.V. Fistula Needle Sets
K213015 · FIE
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 200d
Cleared Apr 08, 2022
TLX SRAs and TLX Gold Abutments
K213063 · NHA
Institut Straumann AG
Dental · 197d
Cleared Apr 08, 2022
Latex Examination Gloves, Powder Free
K213509 · LYY
Shandong Intco Medical Products Co, Ltd.
General Hospital · 157d
Cleared Apr 08, 2022
ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
K213633 · GAG
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 142d
Cleared Apr 08, 2022
Bioabsorbable Anchor
K213958 · MAI
Embody, Inc.
Orthopedic · 112d