92 results · 23ms · Sources: EU EUDAMED, US FDA

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ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.

FDA Recall
Terminated ·Resmed Corporation·Product code BZD·April 23, 2007

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

FDA Recall
Terminated ·ICU Medical, Inc.·Product code ONB·January 3, 2019

Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

FDA Enforcement
Class II ·Terminated·Arrow International Inc·March 18, 2015

Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)

FDA Recall
Terminated ·Sanarus Medical Inc·June 16, 2003

Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument

FDA Recall
Terminated ·Premier Dental Products Co·Product code GEH·April 29, 2004

Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument

FDA Recall
Terminated ·Premier Dental Products Co·Product code GEH·April 29, 2004

Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

FDA Enforcement
Class I ·Terminated·ICU Medical, Inc.·March 6, 2019

Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016

Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain

FDA Enforcement
Class II ·Terminated·Ivoclar Vivadent, Inc.·October 12, 2016