12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584059050·SU7 P, VC PS SABE/MAC SUITE 7
DISCOVERY NM 750B
FDA 510(k)
FDA Class 1
·Radiology
MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, STANDARD, MODEL 310001
FDA 510(k)
FDA Class 1
·Anesthesiology
SOFTACT/SOFT-SENSE
FDA Adverse Event
Injury
·THERASENSE, INC.·Product code CFR·February 24, 2005
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 11, 2013
DEPUY ASR XL FEM IMP SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·July 7, 2011
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR SWITZERLAND·Product code FGE·September 16, 2008
DA VINCI
FDA Adverse Event
Injury
·INTUITIVE SURGICAL, INC·Product code NAY·December 20, 2024
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·November 15, 2023
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·January 7, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024