179 results
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17ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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FoundationOne CDx test report
FDA Enforcement
Class II
·Terminated·Foundation Medicine, Inc.·December 4, 2019
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·November 20, 2013
FoundationOne CDx test report
FDA Recall
Terminated
·Foundation Medicine, Inc.·Product code PQP·August 8, 2019
LIFEPAK CR Plus Automated External Defibrillator. Device is primarily deployed in Public Access Defibrillator (PAD). It is a small lightweight device intended for use by minimally trained responders to treat victims of sudden cardiac arrest... Product is capable of 30 full discharges. Labeling on the device states LIFEPAK CR Plus LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA.
FDA Recall
Terminated
·Physio Control, Inc.·Product code MJK·August 28, 2008
CME America BodyGuard Infusion Pump System, All models of BG 323, BG 121, BG 545, BG CV545, BG 575, BG CV575, and CMExpress
FDA Recall
Terminated
·CME America, LLC·Product code FRN·January 7, 2020
Acetabular Pressurizer; single use and six units per box. The Acetabular Pressurizer 0206-522-000 is an accessory to the Advanced Cement Mixer (ACM). The Acetabular Pressurizer Tiplet P/N 0206-522-012 is sealed in a two pouches, sterilized, and labeled as part number 0206-522-000. This Acetabular Pressurizer is an accessory used to pressurize the cement applied to the prosthesis to be implanted during the surgery. The Acetabular Pressurizer is an injection molded component made with resin material DOW HDPD 10462N which is a rigid plastic once it is molded.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 1, 2013
Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
FDA Enforcement
Class III
·Terminated·Pega Medical Inc.·May 27, 2020
HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation
FDA Enforcement
Class I
·Terminated·Heartsine Technologies, Limited·November 7, 2012
Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.
FDA Recall
Terminated
·Medtronic Cardiovascular·Product code FGE·November 24, 2008
GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code JAK·May 4, 2009
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 22, 2014
Portex 3 Way Stopcock Catalog Number: T1103
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
Portex 3 Way Stopcock Catalog Number: T1202
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
Portex ULTRA-FLO 4 - Way Stopcock Catalog Number: T1209
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1481
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004
Portex 4-Way Stopcock Catalog Number: T1206
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004
Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1554
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code JKA·September 9, 2004
Portex 4 Way ''T-Handle'' Stopcock Catalog Number: T1204
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code FMG·September 9, 2004