8 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SCEPTER XC OCCLUSION BALLOON CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
TENSCARE ITOUCH SURE MODEL ITS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AST (SGOT)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE-SWITZERLAND·Product code NKB·May 15, 2013
BE-HLS 7050#HLS SET ADVANCED 7.0
FDA Adverse Event
Malfunction
·MAQUET CARDIOPULMONARY AG·Product code DTQ·September 17, 2014
EON RECHARGEABLE IPG, 16-CHANNEL
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 2, 2011
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021