58 results
·
7ms
·
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
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
FDA Enforcement
Class II
·Completed·C.R. Bard Inc·March 2, 2022
BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
FDA Enforcement
Class II
·Completed·C.R. Bard Inc·March 2, 2022
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
FDA Enforcement
Class II
·Completed·Baxter Healthcare Corporation·May 11, 2022
Illumina NextSeq 550Dx, REF: 20005715, CE, IVD
FDA Enforcement
Class II
·Completed·Illumina, Inc.·April 6, 2022
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (medium) C3, REF: D138502, Rx Only, CE 2797, STERILE EO, UDI: (01)10846835016277 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Enforcement
Class II
·Completed·Biosense Webster, Inc.·March 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (Large) C3, REF: D138503, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016260 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Enforcement
Class II
·Completed·Biosense Webster, Inc.·March 31, 2021
Biosense Webster, CARTO VIZIGO, Bi-Directional Guiding Sheath, 8.5F (SMALL) C3, REF: D138501, Rx Only, CE 2797, STERILE EO, udi: (01)10846835016253 - Product Usage: provide accessibility and maneuverability in the cardiac anatomy during cardiac electrophysiological mapping and ablation procedures.
FDA Enforcement
Class II
·Completed·Biosense Webster, Inc.·March 31, 2021
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·September 9, 2020