9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DEKA AGAIN PRO family
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALPHATEC
FDA Adverse Event
ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004
OXICARE FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ICON POLYAXIAL PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INTELLIS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 3, 2025
FG6301 DUAL CHNL VOL INFUSIONPUMP,2M8064 RECONDND
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 18, 2008
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025