60 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTREPID SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Humelock II Cemented Shoulder System
FDA UDI
FX SOLUTIONS·03701037306437·HUMELOCK GUIDE Ø2.2mm
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604404·SKYTRON 300/5001/6001/6002/6500/6600/1201 2.25"...
Disposable Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935103660·
CARDIOSAVE RESCUE
FDA UDI
Datascope Corp.·10607567108407·CARDIOSAVE RESCUE
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
FDA 510(k)
FDA Class 2
·Cardiovascular
EBI XFIX DFS RAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CURRENT RF DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·April 26, 2013
MULTI-LUMEN CVC KIT: 2-L 8 FR X 6IN (16C
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code FOZ·April 7, 2011
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·July 17, 2008
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·July 29, 2025
2.5MM REAMING ROD W/BALL TIP 650MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·October 5, 2016
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 6, 2025
BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·July 31, 2013
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·November 15, 2021
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85,
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·July 31, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·December 19, 2022
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-XX & 0998-UC-0800-XX (excluding 0998-00-0800-83, 0998-UC-0800-83 & 0998-00-0800-75) and cart 0997-00-1179
FDA Recall
Open, Classified
·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·May 3, 2018
Cardiosave Rescue. Model Number: 0998-00-0800-83.
FDA Recall
Open, Classified
·Datascope Corp.·Product code DSP·February 7, 2023
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-0800-85, 0998-UC-0800-85.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·December 22, 2021