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Arc Adjustable Radial Cuff Compression Device

FDA 510(k)
FDA Class 2 ·Cardiovascular

ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE

FDA 510(k)
FDA Class 2 ·Cardiovascular

HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS

FDA 510(k)
FDA Class 2 ·Cardiovascular

Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)

FDA 510(k)
FDA Class 2 ·Physical Medicine

FLEXITOUCH SYSTEM

FDA Adverse Event
Injury ·TACTILE SYSTEMS TECHNOLOGY INC·Product code IRP·September 19, 2011

PLASMAFLOW

FDA Adverse Event
Malfunction ·MANAMED, LLC·Product code JOW·June 21, 2024

TX1 TISSUE REMOVAL SYSTEM-MICROTIP

FDA Adverse Event
Malfunction ·AOI, INC.·Product code LFL·January 23, 2014

TX1 TISSUE REMOVAL SYSTEM - MICROTIP

FDA Adverse Event
Malfunction ·AOI INC.·Product code LFL·January 23, 2014

ARTIFICIAL URINARY SPHINCTER

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·November 1, 1996

AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EZY·October 23, 2020

POWERLINK BIFURCATED SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·November 11, 2005

POWERLINK SYSTEM

FDA Adverse Event
Injury ·ENDOLOGIX, INC.·Product code MIH·October 14, 2009

VASCULAR UNK

FDA Adverse Event
Other ·COVIDIEN·Product code JOW·December 16, 2009

MEDLINE

FDA Adverse Event
Malfunction ·MEDLINE INDUSTRIES, LP·Product code DXQ·May 15, 2026

GROSHONG CATHETER

FDA Adverse Event
Injury ·BARD ACCESS SYSTEMS·Product code DQO·August 4, 1999

Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.

FDA Enforcement
Class II ·Terminated·Stryker Sustainability Solutions·May 6, 2020

TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 16, 2009

TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

FDA Adverse Event
Death ·MEDTRONIC CARDIOVASCULAR·Product code MIH·December 16, 2009

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·November 9, 2009

AMS 800 URINARY CONTROL SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code EZY·December 5, 2019