33 results
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40ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TempSure System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bernafon
FDA UDI
Bernafon AG·05711584114773·CZ5 MNR T R, 2.4G NFM SABE DEMO CORAL 5 GPL
APEX REVISION KNEE SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 23, 2024
DEXTRUS 4136
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVZ·July 12, 2011
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·August 4, 2014
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013
BALL HEADS: COCR 01.25.123 COCR BALL HEAD 12/14 Ø 22 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·June 23, 2023
FLAT TITANIUM PECTUS BAR 10.5
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
FLAT TITANIUM PECTUS BAR 12
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DME
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·September 17, 2024
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
M-VIZION FEMORAL REVISION SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 8, 2024
LINER: MPACT 01.26.2244MHC DOUBLE MOBILITY HC LINER 22.2/DMB
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·November 10, 2023
FLAT TITANIUM PECTUS BAR 13IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
FLAT TITANIUM PECTUS BAR 13IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·March 12, 2025
MECTACER BIOLOX DELTA FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·October 2, 2025
STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024
FLAT TITANIUM PECTUS BAR 11IN
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·January 9, 2025