251 results
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22ms
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Sources: EU EUDAMED, US FDA
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
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
SHERPA NX ACTIVE GUIDING CATHETER, 6F MB2, .070", REF SA6MB2. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F 3DRIGHT, .070", REF SA63DRIGHT. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F MAC4.5, .070", REF SA6MAC45. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU5.0, .070", REF SA6EBU50. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F JR3.0, .070", REF SA6JR30. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F AL2.0, .070", REF SA6AL20. for cardiovascular use
FDA Enforcement
Class I
·Completed·Medtronic Vascular·October 9, 2019