18 results · 30ms · Sources: EU EUDAMED, 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