16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221038067·Unitek(TM) Bicuspid Band General Purpose Wide L...
Monterey™ AL
FDA UDI
VB Spine LLC·10888857588301·Cam Lock Driver
PERMANENT PACING LEAD, MODEL PY2
FDA 510(k)
FDA Class 3
·Cardiovascular
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20
FDA 510(k)
FDA Class 1
·Clinical Chemistry
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 13, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 5, 2025
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 4, 2014
PERFORMANCE PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·June 3, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 27, 2011
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
POLARIS SCREW, DIA. 6.5 X UNKNOWN LENGTH
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE, INC.·Product code NKB·May 28, 2025
REVERSE BODY SMALL AND BODY SCREW
FDA Adverse Event
Malfunction
·ASCENSION ORTHOPEDICS·Product code KWS·June 8, 2015
Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025