10 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696851·Digital Analog Screw
PASCO MIC AND MIC/ID PANELS
FDA 510(k)
FDA Class 2
·Microbiology
THERMOFLEX SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 13, 2026
MYCO MED SUPPLIES, INC.
FDA Adverse Event
Malfunction
·NIRAJ INDUSTRIES PVT. LTD.·Product code GES·February 4, 2019
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·April 22, 2013
SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code LIT·April 27, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 1, 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