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
11449–11472 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 2022
Optima Coil System
K223386 · HCG
Balt USA, LLC
Neurology · 29d
Cleared Dec 06, 2022
Cios Select (VA21) Image Intensifier
K223409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 06, 2022
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Dec 05, 2022
BPAP System
K213169 · MNS
BMC Medical Co., Ltd.
Anesthesiology · 433d
Cleared Dec 05, 2022
ClearRead CT
K221612 · OEB
Riverain Technologies, Inc.
Radiology · 185d
Cleared Dec 05, 2022
TruLift Lateral Expandable Spacer System & Lateral Plate System
K221806 · MAX
Life Spine, Inc.
Orthopedic · 166d
Cleared Dec 05, 2022
OK Plus Indicator
K222137 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 139d
Cleared Dec 05, 2022
Zavation Spinal System
K222614 · NKB
Zavation Medical Products, LLC
Orthopedic · 97d
Cleared Dec 05, 2022
Cryopush Cold Compression Device
K222669 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 90d
Cleared Dec 05, 2022
Altaviz Needle Kit
K222681 · FMI
Altaviz, LLC
General Hospital · 90d
Cleared Dec 05, 2022
Mallya Injection Pen Adapter (Mallya® for Solostar®)
K222689 · QOG
Biocorp Production
General Hospital · 90d
Cleared Dec 05, 2022
BriefCase
K222692 · QFM
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Dec 05, 2022
Disposable Medical Face Mask
K223055 · FXX
Xiantao Zhuobo Industrial Co., Ltd.
General Hospital · 67d
Cleared Dec 04, 2022
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt...
K222019 · NLF
Stryker Sustainability Solutions
Anesthesiology · 149d
Cleared Dec 04, 2022
Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For...
K222815 · LZA
Zibo Lanhua Medical Packaging...
General Hospital · 76d
Cleared Dec 04, 2022
Disposable Nitrile Examination Gloves
K223004 · LZA
Jiangxi Handspro Products Solutions...
General Hospital · 66d
Cleared Dec 03, 2022
truSculpt flex
K212866 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 451d
Cleared Dec 03, 2022
White Nitrile Powder Free Patient Examination Glove, Non Sterile
K222713 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K222715 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 03, 2022
Blue Nitrile Powder Free Patient Examination Glove, Non Sterile
K222720 · LZA
Safeskin Retailing (Hk) Limited
General Hospital · 86d
Cleared Dec 02, 2022
CardioGraphe
K213465 · JAK
Arineta , Ltd.
Radiology · 400d
Cleared Dec 02, 2022
CreoDent Solidex Customized Abutment and Screw
K220390 · NHA
Creodent Prosthetics, Ltd.
Dental · 294d
Cleared Dec 02, 2022
SUREcore Plus Biopsy Instrument
K220611 · KNW
Uro-1, Inc.
General & Plastic Surgery · 274d
Cleared Dec 02, 2022
SilentZPro 2.0
K220688 · LRK
Shinrin-Yoku Traders, LLC
Dental · 269d