12 results · 21ms · Sources: EU EUDAMED, US FDA

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CBC PLT-4

FDA 510(k)
FDA Class 2 ·Hematology

LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

BRANAN MEDICAL CORPORATION MONITECT METHAMPHETAMINE DRUG SCREEN TEST

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

WEBSTER QUADROPOLAR - FIXED

FDA Adverse Event
Injury ·BIOSENSE WEBSTER, INC (IRWINDALE)·Product code DRF·June 26, 2012

SMALL WIRE CUTTER 160MM

FDA Adverse Event
Malfunction ·SYNTHES TUTTLINGEN·Product code HXZ·January 26, 2015

STYLE 115 SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·February 20, 2026

ECHELON LINEAR CUTTER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2014

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
Malfunction ·UNKNOWN·Product code ITJ·October 23, 2012

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 6, 2007

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024