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
45865–45888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 2011
ANYRIDGE INTERNAL IMPLANT SYSTEM
K110955 · DZE
Megagen Co., Ltd.
Dental · 231d
Cleared Nov 22, 2011
MIGRA TAB, QUICKSPLINT MIGRAINE
K111066 · MQC
Migratherapy, LLC
Dental · 218d
Cleared Nov 22, 2011
DEVINE SPINAL SYSTEM
K111690 · MNH
Changzhou Orthmed Medical Instrument...
Orthopedic · 159d
Cleared Nov 22, 2011
NB3D BONE VOID FILLER
K111944 · MQV
Pioneer Surgical Technology, Inc.
Orthopedic · 137d
Cleared Nov 22, 2011
PREMIER HB9210 HBA1C ANALYZER
K112015 · LCP
Primus Corporation Dba Trinity Biotech
Chemistry · 132d
Cleared Nov 22, 2011
TRUCLEAR OPERATIVE HYSTEROSCOPE
K112134 · HIH
Smith & Nephew, Inc.
Obstetrics & Gynecology · 118d
Cleared Nov 22, 2011
FRAXION
K112210 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 113d
Cleared Nov 22, 2011
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL
K112220 · BZD
Devilbiss Healthcare, LLC
Anesthesiology · 112d
Cleared Nov 22, 2011
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K112270 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
K112273 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
CLEARVISION
K112380 · MUH
Midmark Corp.
Radiology · 97d
Cleared Nov 22, 2011
ZAVATION SPINAL SYSTEM
K112484 · MNI
Zavation, LLC
Orthopedic · 85d
Cleared Nov 22, 2011
UNIMED BLOOD PRESSURE CUFF
K112544 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 82d
Cleared Nov 22, 2011
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
K112647 · DXN
Wistron Corporation
Cardiovascular · 71d
Cleared Nov 22, 2011
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · MWI
Welch Allyn, Inc.
Cardiovascular · 68d
Cleared Nov 22, 2011
AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM
K112760 · MLR
STERIS Corporation
General Hospital · 61d
Cleared Nov 22, 2011
RENASYS AB ABOMINAL DRESSING KIT
K112784 · FTL
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE...
K112963 · NBW
Taidoc Technology Corporation
Chemistry · 48d
Cleared Nov 22, 2011
DIMENSION CLINICAL CHEMISTRY SYSTEM
K112999 · JJE
Siemens Healthcare Diagnostics
Chemistry · 46d
Cleared Nov 22, 2011
SYNGO AORTIC VALVEGUIDE SOFTWARE
K113027 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 42d
Cleared Nov 22, 2011
INFINIX-CCI
K113052 · MQB
Toshiba America Medical Systems, In.C
Radiology · 40d
Cleared Nov 22, 2011
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
K113139 · DIO
Lin-Zhi International, Inc.
Chemistry · 29d
Cleared Nov 21, 2011
SPIRODOC
K103530 · BZG
Medical International Research USA, Inc.
Anesthesiology · 355d
Cleared Nov 21, 2011
PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM
K110614 · DJZ
Seju Engineering Co., Ltd.
Chemistry · 263d