8 results · 20ms · Sources: EU EUDAMED, US FDA

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INTERFACE ACETABULAR CUP LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

SPERMASSIST

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

COLLAGEN WOUND DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

ALTRX +4 10D 36IDX54OD

FDA Adverse Event
Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 3, 2013

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 2, 2011

PUMP MMT-715NAS PRDGM INS V2.1 SK EN

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code LZG·August 1, 2008

DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

FDA Enforcement
Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012

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