10 results · 27ms · Sources: EU EUDAMED, US FDA

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UNIPLAIN & UNICHROM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809871913·FOR MEN 15-20 MM HG THIGH MICRO DOT BAND CLOSED...

MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

WIZAIR COMPRESSION SYSTEM

FDA 510(k)
FDA Class 2 ·Cardiovascular

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 6, 2011

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Malfunction ·AMERICAN MEDICAL SYSTEMS·Product code GEX·April 1, 2013

ENDOTAK RELIANCE G

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

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

Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024

Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

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