18 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MD300K1 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036030483·
K090539
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code MNS·February 26, 2026
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
FDA 510(k)
FDA Class 2
·Hematology
VITALOGRAPH BASE STATION
FDA 510(k)
FDA Class 2
·Anesthesiology
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·June 19, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·May 2, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 15, 2014
COMBINATION REAMER ASSEMBLY OMEGA STANDARD
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·April 19, 2011
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 19, 2013
ISODUR PROSTHESIS HEAD 12/14 32MM XL
FDA Adverse Event
Malfunction
·AESCULAP AG AND CO KG·Product code LPH·March 28, 2014
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 21, 2022
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·November 9, 2011
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·November 9, 2011
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·November 9, 2011
PINNACLE MTL INS NEUT36IDX54OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 9, 2011
CORAIL2 LAT COXA VARA SIZE 10
FDA Adverse Event
Injury
·DEPUY FRANCE SAS - 3003895575·Product code KWA·November 9, 2011
ACE Control Set - IVD Control set for the quantitative determination of Angiotensin Converting Enzyme (ACE) REF 1667001
FDA Enforcement
Class III
·Ongoing·Sentinel CH SpA·July 14, 2021