10 results · 28ms · Sources: EU EUDAMED, US FDA

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VARELISA GLIADIN IGG ANTIBODIES

FDA 510(k)
FDA Class 2 ·Immunology

MODIFICATION TO OMEGA 21 SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT

FDA 510(k)
FDA Class 2 ·Ophthalmic

LOGIC CR TIB INSERT STD, SZ 3, 15MM

FDA Adverse Event
Injury ·EXACTECH, INC.·Product code JWH·May 14, 2024

ACTIVA

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·April 8, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 23, 2011

INTRO-FLEX SHEATH INTRODUCER WITH AMC THROMBOSHIELD

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DYB·May 8, 2008

HARMONY DELIVERY CATHETER SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC IRELAND·Product code NPV·February 13, 2026

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

The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018