10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO: LIGAFIX INTERFERENCE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696523·Single-Unit Digital Analog
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105070·Draw Rod, Primal T- Handle
VISTAKON (METHAFILCON A) CONTACT LENSES
FDA 510(k)
FDA Class 2
·Ophthalmic
CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FREESTYLE LIGHT
FDA Adverse Event
ABBOTT DIABETES·Product code NBW·April 18, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·March 29, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 1, 2008
KYPHON KURVE BONE FILLER DEVICE 13GA
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO·Product code KIH·July 14, 2020
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