24 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENHANCE SPERM FREEZE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Asnis
FDA UDI
Stryker GmbH·07613154631216·CANNULATED SCREW
InTess L
FDA UDI
Kalitec Direct LLC·B07312K0310170·T-Handle, Fixed, 1/4" Square
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101170·Distractor, Smooth Paddle, Lordotic, 17mm
GUIDANT AXIUS CORONARY SHUNT
FDA 510(k)
FDA Class 2
·Cardiovascular
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Widex
FDA UDI
Widex A/S·05706069665765·COMPASS GPS V2.4 package (English)
Widex
FDA UDI
Widex A/S·05706069665796·COMPASS GPS V2.4 package (Spanish)
Widex
FDA UDI
Widex A/S·05706069665789·COMPASS GPS V2.4 package (French)
Widex
FDA UDI
Widex A/S·05706069665772·COMPASS GPS V2.4 package (German)
VISIONAIRE GII FEMOR
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KDC·April 2, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·March 26, 2011
ALARIS GEMINI PC-IT
FDA Adverse Event
Injury
·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·April 15, 2008
EVOLUT FX VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·November 5, 2025
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·October 23, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·November 28, 2020
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021
PENTAX
FDA Adverse Event
Injury
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·February 25, 2021