18 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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