21 results · 27ms · Sources: EU EUDAMED, US FDA

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XIDF-AWS801, Angio Workstation, V6.10

FDA 510(k)
FDA Class 2 ·Radiology

AGXO

FDA UDI
Oticon A/S·05707131283269·H110V2, MINIBTE 312 WL 85 TC AGXO

PERIMETER C SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

VARELISA RECOMBI CTD SCREEN, MODEL 13096

FDA 510(k)
FDA Class 2 ·Immunology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE GMBH·Product code NBW·June 6, 2013

SYNCHROMED II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 21, 2011

LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·August 28, 2008

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 28, 2021

A7 ANESTHESIA SYSTEM

FDA Adverse Event
Malfunction ·SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.·Product code BSZ·February 15, 2017

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 12, 2018

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 14, 2018

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 23, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·June 14, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·April 26, 2021

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·June 13, 2019

FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code DTK·September 12, 2018

FLIPPER MREYE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Malfunction ·WILLIAM COOK EUROPE·Product code KRD·September 12, 2019

MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

FDA Adverse Event
Injury ·WILLIAM COOK EUROPE·Product code KRD·October 11, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022