10 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BP652N (HEM-6300-Z)
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII
FIXTEMP C&B
FDA 510(k)
FDA Class 2
·Dental
STAT MEDICAL PEN NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·October 23, 2017
ROTATING MULTIPLE CLIP APPLIER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·June 3, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 12, 2014
NI
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWP·June 22, 2011
CODA BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code DQY·September 10, 2019
PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. 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