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
12409–12432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 23, 2022
ATEC IOM Accessory Instruments
K221821 · PDQ
Alphatec Spine, Inc.
Neurology · 92d
Cleared Sep 23, 2022
Wet Flavored Personal Lubricants
K221829 · NUC
Trigg Laboratories, Inc.
Obstetrics & Gynecology · 92d
Cleared Sep 23, 2022
3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228
K222152 · JOJ
3M Company
General Hospital · 65d
Cleared Sep 23, 2022
Medical Surgical Mask
K222204 · FXX
Guangzhou Zhengkang Medical Equipment...
General Hospital · 60d
Cleared Sep 23, 2022
Diosculpt
K222265 · PKT
Shanghai Wonderful Opto-Electrics...
General & Plastic Surgery · 57d
Cleared Sep 23, 2022
reepot Nd
K222555 · GEX
Ilooda Co,., Ltd.
General & Plastic Surgery · 31d
Cleared Sep 23, 2022
Align
K222561 · OVD
Acuity Surgical Devices, LLC
Orthopedic · 30d
Cleared Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
K222568 · OBJ
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Sep 23, 2022
FREEPRINT crown
K222877 · EBF
Detax GmbH
Dental · 1d
Cleared Sep 22, 2022
Dual Switch
K211605 · GEX
Laser Engineering, Inc.
General & Plastic Surgery · 485d
Cleared Sep 22, 2022
WasherCap Fixation System
K212197 · MBI
Abanza Tecnomed S.L
Orthopedic · 435d
Cleared Sep 22, 2022
CellFX System
K213674 · GEI
Pulse Biosciences, Inc.
General & Plastic Surgery · 304d
Cleared Sep 22, 2022
TRANBERG Thermoguide Therapy System
K214125 · ONO
Clinical Laserthermia Systems, AB
Neurology · 266d