8 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Torc Body
FDA 510(k)
FDA Class 2
·Physical Medicine
Bernafon
FDA UDI
Bernafon AG·05711584087138·ZR1, KIT 312 2.4G NFM 75 L BE ZERENA 1
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
FDA 510(k)
FDA Class 2
·Dental
IDENTEVENT, VERSION 1.0G
FDA 510(k)
FDA Class 2
·Neurology
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Injury
·BIOENTERICS CORPORATION·Product code LTI·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 20, 2013
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160.
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026