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
17569–17592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2021
ivi N3003 Surgical face Mask, ivi N6006 Surgical mask
K201896 · FXX
Iob Medical, Inc.
General Hospital · 265d
Cleared Mar 30, 2021
Surgical Face Masks
K202708 · FXX
Intco Medical(Hk) Co., Ltd.
General Hospital · 195d
Cleared Mar 30, 2021
E-Denture Pro
K203641 · EBI
Envisiontec GmbH
Dental · 106d
Cleared Mar 30, 2021
BOMEDENT Apex locator, WISMY Apex locator
K203836 · LQY
Changzhou Bomedent Medical Technology...
Dental · 90d
Cleared Mar 30, 2021
Blue Nitrile Exam Glove, Powder Free
K210058 · LZA
Great Harvest Trading Co., Ltd.
General Hospital · 78d
Cleared Mar 30, 2021
PicoSure Workstation
K210226 · GEX
Cynosure, LLC
General & Plastic Surgery · 61d
Cleared Mar 30, 2021
EMPOWR Porous Femur with HAnano SurfaceTM
K210308 · MBH
Encore Medical, L.P.
Orthopedic · 55d
Cleared Mar 30, 2021
3M Bair Hugger Temperature Management System (Model 675)
K210603 · DWJ
3M Company
Cardiovascular · 29d
Cleared Mar 29, 2021
LumiCare Caries Diagnostic Rinse
K200601 · LFC
GreenMark Biomedical, Inc.
Dental · 385d
Cleared Mar 29, 2021
EMMA Capnograph
K201590 · CCK
Masimo Corporation
Anesthesiology · 290d
Cleared Mar 29, 2021
Surgical Mask
K202191 · FXX
Wuhan Zonsen Medical Products Co., Ltd.
General Hospital · 236d
Cleared Mar 29, 2021
DORO QR3 Headrest System (Aluminum)
K203505 · HBL
Pro-Med Instruments GmbH
Neurology · 119d
Cleared Mar 29, 2021
LaserCap Family of Lasers 300, 224, 120 & 80
K203826 · OAP
Transdermal Cap, Inc.
General & Plastic Surgery · 90d
Cleared Mar 29, 2021
REMI
K203827 · OMC
Epitel, Inc.
Neurology · 90d
Cleared Mar 29, 2021
StarGuide
K210173 · KPS
Ge Healthcare
Radiology · 66d
Cleared Mar 28, 2021
DVT-4000S
K203417 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 129d
Cleared Mar 26, 2021
TruAbutment DS, TruBase S
K201197 · NHA
Truabutment, Inc.
Dental · 326d
Cleared Mar 26, 2021
MyCRO Band
K201426 · MVA
Otto Bock Healthcare LP
Neurology · 301d
Cleared Mar 26, 2021
Tranberg CLS Laser Applicator
K201466 · GEX
Clinical Laserthermia Systems, AB
General & Plastic Surgery · 297d
Cleared Mar 26, 2021
RG 3ml Medication Cartridge
K201634 · MRZ
Chengdu Shifeng Medical Technology...
General Hospital · 283d
Cleared Mar 26, 2021
AllerBlock Junior
K201734 · NUP
Nasaleze International, Ltd.
Ear, Nose, Throat · 274d
Cleared Mar 26, 2021
Spacelabs Lifescreen PRO Analyzer
K201921 · DQK
Spacelabs Healthcare, Ltd.
Cardiovascular · 259d
Cleared Mar 26, 2021
A8, A9 Anesthesia System
K201957 · BSZ
Shenzhen Mindray Bio-Medical...
Anesthesiology · 255d
Cleared Mar 26, 2021
Surgivisio system
K202547 · OWB
Surgivisio
Radiology · 205d