321 results · 16ms · Sources: EU EUDAMED, US FDA

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AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

FDA Recall
Completed ·Accriva Diagnostics, Inc.·Product code DQA·September 27, 2024

AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.

FDA Enforcement
Class II ·Completed·Accriva Diagnostics, Inc.·November 6, 2024

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Enforcement
Class II ·Completed·Encore Medical, Lp·April 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Enforcement
Class II ·Completed·Encore Medical, Lp·April 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Enforcement
Class II ·Completed·Encore Medical, Lp·April 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Enforcement
Class II ·Completed·Encore Medical, Lp·April 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Enforcement
Class II ·Completed·Encore Medical, Lp·April 4, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Recall
Completed ·Product code KWS·January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Recall
Completed ·Product code KWS·January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Recall
Completed ·Product code KWS·January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Recall
Completed ·Product code KWS·January 29, 2018

Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.

FDA Recall
Completed ·Product code KWS·January 29, 2018

MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device

FDA Enforcement
Class II ·Completed·Medacta Usa Inc·April 26, 2023

SHERPA NX ACTIVE GUIDING CATHETER, 6F SL5.0, .070", REF SA6SL50. for cardiovascular use

FDA Enforcement
Class I ·Completed·Medtronic Vascular·October 9, 2019

SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use

FDA Enforcement
Class I ·Completed·Medtronic Vascular·October 9, 2019