12 results · 35ms · Sources: EU EUDAMED, US FDA

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ANSPACH MENISECTOMY KNIFE

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

SOLAS ANATOMIX SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

ELECSYS HCG AND BETA TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

SYRINGE S2 5ML 22GA 1-1/4IN BD CHINA

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·April 24, 2019

ARCHITECT C8000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·April 25, 2017

M2A-MAGNUM PF CUP 52ODX46ID

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 9, 2014

DBS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS·Product code LGW·January 26, 2006

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 28, 2015

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

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018