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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
70921–70944 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2003
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
K032852 · DRM
Revivant Corp.
Cardiovascular · 61d
Cleared Nov 12, 2003
VITEK 2 GRAM NEGATIVE MOXIFLOXACIN
K032861 · LON
bioMerieux, Inc.
Microbiology · 61d
Cleared Nov 12, 2003
KIMBERLY-CLARK PATIENT WARMING SYSTEM - MODEL 100 CONTROL UNIT AND ENERGY...
K033021 · DWJ
Kimberly-Clark Corp.
Cardiovascular · 47d
Cleared Nov 12, 2003
XISCAN 4000 TRANSPORTABLE IMAGING SYSTEM
K033066 · OXO
Xitec Holdings, LLC
Radiology · 44d
Cleared Nov 12, 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 02
K033097 · ITI
Taiwan King Strong Co., Ltd.
Physical Medicine · 44d
Cleared Nov 12, 2003
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
K033199 · KPS
Is2 Medical Systems, Inc.
Radiology · 41d
Cleared Nov 12, 2003
ESG 4-WHEEL SCOOTER, ESG-03
K033204 · INI
Emg Technology Co., Ltd.
Physical Medicine · 41d
Cleared Nov 12, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S600
K033219 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 40d
Cleared Nov 12, 2003
BE-MOBILE 4-WHEELED ELECTRIC SCOOTER, MODEL DK S500
K033239 · INI
Tung Keng Enterprise Co., Ltd.
Physical Medicine · 37d
Cleared Nov 12, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K033304 · MHX
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Nov 12, 2003
MODIFICATION TO: HI-ART SYSTEM
K033347 · IYE
Tomotherapy Incorporated
Radiology · 23d
Cleared Nov 12, 2003
BESTALOY
K033434 · EJJ
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 12, 2003
E-SARANG 86, DM78, DM55
K033435 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 15d
Cleared Nov 10, 2003
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES...
K030583 · LYY
Shen Wei (Usa), Inc.
General Hospital · 259d
Cleared Nov 10, 2003
ANZAI AZ-733 RESPIRATORY GATING SYSTEM
K031385 · LHN
Anzai Medical Co., Ltd.
Radiology · 193d
Cleared Nov 10, 2003
RELIANT LASER SYSTEM
K031795 · GEX
Reliant Technologies, Inc.
General & Plastic Surgery · 153d
Cleared Nov 10, 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · MHI
Remel, Inc.
Microbiology · 150d
Cleared Nov 10, 2003
BLOOD PRESSURE MONITOR, MODEL M100
K032308 · DXN
Meditek Technology, Inc.
Cardiovascular · 108d
Cleared Nov 10, 2003
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Nov 10, 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 10, 2003
POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
K032607 · DZI
Linvatec Corp.
Dental · 77d
Cleared Nov 10, 2003
MEDICHEART, MODEL RELEASE 1
K032823 · JAK
Medicsight
Radiology · 61d
Cleared Nov 10, 2003
STAR (LUNAR SERIES) MONITORING SYSTEM
K032867 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d
Cleared Nov 10, 2003
PLANET MONITORING SYSTEM
K032871 · MWI
Larsen & Toubro Limited
Cardiovascular · 56d