Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Cleared only ×
175,820 results
40201–40224 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 24, 2013
DIAGNOCAM
K123402 · NTK
Kaltenbach & Voigt GmbH
Dental · 323d
Cleared Sep 24, 2013
CRYSTAL ULTRA
K130654 · EIH
Dental Laboratory Milling Supplies,...
Dental · 196d
Cleared Sep 24, 2013
SHENGGUANG MANUAL WHEELCHAIR
K131529 · IOR
Pingdingshan Shenxing Healthcare...
Physical Medicine · 119d
Cleared Sep 24, 2013
GE ECHOPAC
K131685 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 106d
Cleared Sep 24, 2013
BRILLIANCE ICT
K131773 · JAK
Philips Healthcare (Cleveland)
Radiology · 99d
Cleared Sep 24, 2013
VOLUSON I/E
K131937 · IYN
Ge Healthcare
Radiology · 89d
Cleared Sep 24, 2013
AIXPLORER
K132171 · IYN
Supersonic Imagine
Radiology · 71d
Cleared Sep 24, 2013
AIXPLORER
K132274 · IYN
Supersonic Imagine
Radiology · 64d
Cleared Sep 23, 2013
BELIMED STEAM STERILIZER MST-V
K130172 · FLE
Belimed, Inc.
General Hospital · 242d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Sep 23, 2013
X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINER
K130365 · OQG
Encore Medical, L.P.
Orthopedic · 222d
Cleared Sep 23, 2013
RELIANCE CERVICAL IBF SYSTEM
K131429 · ODP
Reliance Medical Systems, LLC
Orthopedic · 129d
Cleared Sep 23, 2013
SFI-BAR
K131526 · NHA
Cendres & Metaux SA
Dental · 118d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 23, 2013
PIPELINE KNEE SYSTEM
K132046 · JWH
Pipeline Orthopedics
Orthopedic · 83d
Cleared Sep 23, 2013
DESARA MESH, DESARA BLUE
K132069 · OTN
Caldera Medical, Inc.
Gastroenterology & Urology · 82d
Cleared Sep 23, 2013
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K132508 · OZE
Centers For Disease Control and...
Microbiology · 42d
Cleared Sep 23, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
K132672 · LNS
Dornier Medtech America
Gastroenterology & Urology · 27d
Cleared Sep 23, 2013
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
K132692 · PSZ
Becton, Dickinson and Company
Microbiology · 25d
Cleared Sep 20, 2013
SINUFLUSH LAVAGE SYSTEM
K131177 · KAR
Hedgepath, LLC
Ear, Nose, Throat · 148d
Cleared Sep 20, 2013
MROZ REVERSE OSMOSIS SYSTEM
K131622 · FIP
Ameriwater
Gastroenterology & Urology · 109d
Cleared Sep 20, 2013
COROENT SINGLE TAB SYSTEM
K131723 · OVD
Nuvasive, Inc.
Orthopedic · 100d
Cleared Sep 20, 2013
MULTICHEM IA AND IA PLUS
K132091 · JJY
Techno-Path Manufacturing , Ltd.
Chemistry · 74d
Cleared Sep 20, 2013
MULTICHEM WBT
K132174 · DIF
Techno-Path Manufacturing , Ltd.
Toxicology · 67d