51 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation
FDA 510(k)
FDA Class 2
·Anesthesiology
X-CORE
FDA UDI
Nuvasive, Inc.·00887517426550·X-CORE 2 Ti Core, Ø18x47-79mm
Extraction Rod
FDA UDI
I.T.S. GmbH·09120047308219·Extraction Rod, Cannulated Femur Nail
OsteoMed
FDA UDI
OSTEOMED LLC·00845694053563·NeuroPack, Profile 0, 1 Large Bur Hole plate, 6...
S8 ESCAPE II
FDA 510(k)
FDA Class 2
·Anesthesiology
DIGITAL ULTRASOUND SCANNER
FDA 510(k)
FDA Class 2
·Radiology
SYNTHES ORTHOPEDICS
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code JDS·January 22, 2008
STENT - VASCULAR RECONSTRUCTION
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF, INC·Product code NJE·May 9, 2018
COOKD.A.S.H. DOMETIP DOUBLE LUMEN SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL, INC.·Product code KNS·June 13, 2013
UNICEL® DXI 600 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011
CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·September 26, 2008
Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·April 24, 2019
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·December 13, 2021
REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·July 5, 2023
REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+0MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·November 24, 2022
SHOULDER SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·December 2, 2024
ANATOMIC SHOULDER PROSTHESIS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·May 23, 2025
REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·January 12, 2022
REVERSE SHOULDER SYSTEM GLENOSPHERE 36X27
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·June 25, 2021
ANATOMICAL SHOULDER SYSTEM HC PEGGED GLENOID 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·September 21, 2021