8 results
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36ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COOL-TIP SWITCHING CONTROLLER, CTSW CONTROL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAPAROSCOPIC MONOPOLAR SPATULA TIP AND SHEATH
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code GEI·September 17, 2012
REPICCI LOCKED KEEL TIBIAL BEARING
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
STELLARIS 23G VIT CUTTER 6/BX
FDA Adverse Event
Malfunction
·BAUSCH & LOMB, INC.·Product code HQC·April 17, 2013
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·March 29, 2011
TEMPO
FDA Adverse Event
Malfunction
·ARJO MED AB LTD.·Product code FNG·July 3, 2008
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024