13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER
FDA 510(k)
FDA Class 2
·General Hospital
AGXO
FDA UDI
Oticon A/S·05707131257611·H150, BTE 13 WL 85 TC AGXO
COMPREHENSIVE LOCKING SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HWC·July 5, 2019
MONOSYN VIOLET 3/0 (2) 70CM HR17 (M).RCP
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL, S.A.·Product code GAM·February 8, 2024
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
FDA 510(k)
FDA Class 3
·Cardiovascular
FUNNEL GUIDE CATHETER MODEL G1020608
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 29, 2025
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 29, 2013
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·August 22, 2008
TOTALCARE
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 14, 2011
THERMAGE CPT SYSTEM
FDA Adverse Event
Injury
·SOLTA MEDICAL, INC·Product code GEI·November 12, 2020
THERMAGE CPT SYSTEM TIP
FDA Adverse Event
Injury
·SOLTA MEDICAL INC·Product code GEI·November 30, 2022
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023