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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