22 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
FDA 510(k)
FDA Class 2
·Orthopedic
EVO 2 ST
FDA UDI
DENTAL MANUFACTURING SPA·08056865012834·
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036031398·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029216·Iris Scissor
11.5 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197029193·Iris Scissors
curved...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197411516·Iris Scissors
curved...
TUTA HEALTHCARE ARTHROSCOPY FLUSHING SET, MODEL 80.601
FDA 510(k)
FDA Class 2
·Orthopedic
ESTHETICA
FDA 510(k)
FDA Class 2
·Dental
RESPIRONICS
FDA Adverse Event
Malfunction
·Product code MNT·April 8, 2021
MG II®
FDA UDI
Zimmer, Inc.·00889024186798·
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 3, 2022
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·August 20, 2022
PULSE GEN MODEL 102
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·May 20, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·May 26, 2011
IN TOUCH
FDA Adverse Event
Malfunction
·STRYKER MEDICAL QUEBEC LP·Product code FNL·August 15, 2008
INDIGO SYSTEM SEPARATOR 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·September 13, 2022
V.A.C. FREEDOM THERAPY SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·February 15, 2021
INDIGO SYSTEM ASPIRATION CATHETER 7D
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEW·October 13, 2023
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software
FDA Enforcement
Class II
·Ongoing·Auris Health, Inc·February 25, 2026
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
FDA Enforcement
Class II
·Ongoing·AURIS HEALTH INC·October 16, 2024