8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M Attest Super Rapid 5 Steam-Plus Challenge Pack
FDA 510(k)
FDA Class 2
·General Hospital
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
IVAS BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Orthopedic
BELIFU
FDA Adverse Event
Injury
·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020
QUICKSET 1PC FLEX DRILL BIT 25
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC.·Product code LXH·October 6, 2008
PUMP IN STYLE ADVANCED BREAST PUMP BACKPACK
FDA Adverse Event
Malfunction
·MEDELA INC.·Product code HGX·June 25, 2013
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code MAF·August 5, 2011
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016