35 results · 21ms · Sources: EU EUDAMED, US FDA

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KEELER KAPTURE SOFTWARE

FDA 510(k)
FDA Class 2 ·Ophthalmic

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015374407·STANDARD LOCKING SCREW L45.0MM D4.0MM

Cancellous Screw, Cannulated

FDA UDI
I.T.S. GmbH·09120034306075·Cancellous Screw, Cannulated, D=4.0mm, L=50mm

Thermoflect

FDA UDI
Encompass Group, L.L.C.·30612899514455·THERMOFLECT JACKET, L, 25EA ...

ORTHOFIX

FDA UDI
ORTHOFIX SRL·18059015373905·STANDARD LOCKING SCREW L45.0MM D4.0MM STERILE

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981161576·Z-Rod, Dia. 6.0mm, Co-Cr, 450mm

VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996

FDA 510(k)
FDA Class 2 ·Immunology

I-ROOT

FDA 510(k)
FDA Unclassified ·Unknown

T:SLIM G5 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·March 19, 2019

PLEURX LOCKABLE DRAINAGE LINE SET

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·April 2, 2026

CONFIRM

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC, CRMD·Product code MXC·January 13, 2014

MONOPOLAR CURVED SCISSORS INSTRUMENT

FDA Adverse Event
Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·May 31, 2013

CORE MICRO DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 17, 2011

UNKNOWN SHOULDER COMPONENTS

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code KWT·August 16, 2023

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

PLEURX

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·September 26, 2025

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·January 20, 2026

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Injury ·HEARTWARE, INC·Product code DSQ·March 28, 2016

HEARTWARE® VENTRICULAR ASSIST SYSTEM

FDA Adverse Event
Injury ·HEARTWARE, INC.·Product code DSQ·March 18, 2016

PLEURX DRAINAGE KIT 1000ML

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·October 15, 2025