FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69793–69816 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2003
Y.E.S POWERED WHEELCHAIR. T180
K032512 · ITI
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 90d
Cleared Nov 12, 2003
ENDO PAT 2000
K032519 · DQK
Itamar Medical
Cardiovascular · 89d
Cleared Nov 12, 2003
ORTRAUTEK TRAUMA SYSTEM
K032520 · JEY
Tekka
Dental · 89d
Cleared Nov 12, 2003
WU'S 4-WHEELED SCOOTER, WT-L4JR
K032617 · INI
Wu'S Tech Co., Ltd.
Physical Medicine · 79d
Cleared Nov 12, 2003
ULTRADENT CITRIC ACID 10% SOLUTION
K032627 · KJJ
Ultradent Products, Inc.
Dental · 78d
Cleared Nov 12, 2003
ELECSYS PROBNP IMMUNOASSAY
K032646 · NBC
Roche Diagnostics Corp.
Chemistry · 77d
Cleared Nov 12, 2003
Y.E.S. POWERED WHEELCHAIR, MODEL T200
K032669 · ITN
Yeou Eir Shuen Machinery Co., Ltd.
Physical Medicine · 76d
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