18 results · 24ms · Sources: EU EUDAMED, US FDA

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FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

BOLTON PTA CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

CD SPINAL SYSTEM

FDA Adverse Event
Injury ·SOFAMOR DANEK EUROPE·Product code KWQ·February 19, 1999

*

FDA Adverse Event
Injury ·Product code FHW·September 26, 1996

CRYOVALVE

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code MIE·October 7, 1998

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 2, 2026

SYNCHROMED

FDA Adverse Event
Malfunction ·MEDTRONIC, INC.·Product code LKK·February 16, 1999

DELTA CER FM HD 036/-4MM 12/14

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·April 23, 2026

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 29, 2013

ENDOPATH** ETS45

FDA Adverse Event
Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·July 23, 2008

UNKNOWN AVANTAGE HEAD

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·March 6, 2025

BIOLOX DELTA CERAMIC FEMORAL HEAD

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·March 2, 2017

32MM COCR BIOMET FEM HD -3 NK

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code LZO·April 30, 2025

AIR DERMATOME HANDPIECE

FDA Adverse Event
Malfunction ·ZIMMER SURGICAL·Product code GFD·September 19, 2013

CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012