11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LH-75T PHOTOTHERAPY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776413330·Austin Tissue Retractor #3 11cm, 4.5"
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
FDA 510(k)
FDA Class 1
·General Hospital
GSI 2000 MIDDLE EAR ANALYZER
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022
RECON DRILL 6MM X 489MM
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HTW·May 2, 2013
COMPRESSOR MINI
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code BTI·August 18, 2014
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·MERZ AESTHETICS, INC.·Product code LMH·May 6, 2011
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025
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