40 results · 13ms · Sources: EU EUDAMED, US FDA

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Widefield OCT software feature for the Spectralis HRA+OCT and variants

FDA Enforcement
Class II ·Terminated·Heidelberg Engineering·May 2, 2018

Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

FDA Enforcement
Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-500-025.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 100 mL AutoFuser PainPump, dual site continuous, 2 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0531-200-250.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheters, sterile, REF 0535-400-225.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10.0 in. catheters, sterile, REF 0535-400-210.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-200-050.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 2.5 in. catheter, sterile, REF 0532-400-225.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 10 in. catheters, sterile, REF 0532-400-210.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5" catheter, sterile, REF 0531-200-025.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 550 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0535-400-250.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 1 x 5.0 in. catheter, sterile, REF 0532-500-050.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 6 mL/hr, 2 mL bolus, sterile, REF 0535-626-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 x 2.5 in. catheter, sterile, REF 0532-200-025.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, dual site continuous, 4 mL/hr, 2 x 5.0 in. catheters, sterile, REF 0532-400-250.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 100 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, sterile, REF 0531-216-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 5 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-526-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 550 mL AutoFuser PainPump, single site continuous with bolus, 4 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0535-426-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 100 mL AutoFuser PainPump, single site continuous with bolus, 2 mL/hr, 1 mL bolus, 60 minute bolus refill, standard catheter, sterile, ; REF 0531-216-001.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009

Stryker 275 mL AutoFuser PainPump, single site continuous, 2 mL/hr, 2 mL bolus, 60 minute bolus refill, sterile, REF 0532-226-000.

FDA Recall
Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEB·May 14, 2009