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
51025–51048 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 2010
BLOM-SINGER INDWELLING TEP OCCLUDER
K093258 · EWL
Helix Medical, LLC
Ear, Nose, Throat · 135d
Cleared Mar 03, 2010
VIT KIT - FREEZE AND THAW
K093273 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 135d
Cleared Mar 03, 2010
VINTAGE MP
K093559 · EIH
Shofu Dental Corp.
Dental · 105d
Cleared Mar 03, 2010
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
K093594 · KAM
Acclarent, Inc.
General & Plastic Surgery · 104d
Cleared Mar 03, 2010
MD300C1 FINGERTIP PULSE OXIMETER
K093757 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 86d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Mar 03, 2010
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
K093894 · EFA
Anthogyr
Dental · 75d
Cleared Mar 03, 2010
TEMP IT
K100413 · EBF
Spident Co., Ltd.
Dental · 15d
Cleared Mar 03, 2010
ZEISS INFRARED 800 WITH FLOW 800 OPTION
K100468 · IZI
Carl Zeiss Surgical GmbH
Radiology · 13d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · JSO
bioMerieux, Inc.
Microbiology · 326d
Cleared Mar 02, 2010
A-GRIX RESORBABLE BONE VOID FILLER
K091688 · MQV
Ag Digital Technology Corp.
Orthopedic · 265d
Cleared Mar 02, 2010
MEDACTA BIPOLAR HEAD
K091967 · KWY
Medacta International S.A.
Orthopedic · 244d
Cleared Mar 02, 2010
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD...
K092902 · NBW
Taidoc Technology Corporation
Toxicology · 162d
Cleared Mar 02, 2010
ANAPNOGUARD ENDOTRACHEAL TUBE
K093126 · BTP
Hospitech Respiration , Ltd.
Anesthesiology · 151d
Cleared Mar 02, 2010
C-MOR VISUALIZATION DEVICE
K093717 · HRX
Axis Surgical Technologies, Inc.
Orthopedic · 90d
Cleared Mar 02, 2010
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
K093764 · NBW
Biotest Medical Corp.
Chemistry · 85d
Cleared Mar 01, 2010
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS
K082823 · CFN
The Binding Site Group , Ltd.
Immunology · 522d
Cleared Mar 01, 2010
NMI FC
K091634 · DTL
Navilyst Medical, Inc.
Cardiovascular · 270d
Cleared Mar 01, 2010
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS
K092244 · EWO
Diagnostic Group, LLC
Ear, Nose, Throat · 216d
Cleared Mar 01, 2010
GEL FILLED GUM SOOTHER
K092494 · KKO
Luv N' Care, Ltd.
Dental · 199d
Cleared Mar 01, 2010
ECHOPLAQUE
K092842 · LLZ
Indec Systems, Inc.
Radiology · 167d
Cleared Mar 01, 2010
VASHE WOUND CLEANSING SYSTEM
K093155 · FRO
Puricore, Inc.
General & Plastic Surgery · 146d
Cleared Mar 01, 2010
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
K093414 · LJT
Smiths Medical Asd, Inc.
General Hospital · 119d
Cleared Mar 01, 2010
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
K093719 · DZL
Osteogenics Biomedical, Inc.
Dental · 89d