14 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARDIOSTREAM SONOAIM
FDA 510(k)
FDA Class 2
·Radiology
CARDINAL HEALTH
FDA UDI
Cardinal Health 200, LLC·10887488478029·LACERATION TRAY W 040 0407G
SYRINGE MANAGEMENT SYSTEM, MODEL SMS-1
FDA 510(k)
FDA Class 2
·General Hospital
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
UNKNOWN COPELAND SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·April 14, 2017
COPELAND SH HUM SZ4 STND PLUS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·June 8, 2016
UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·October 21, 2016
UNKNOWN COPELAND RESURFACING SHOULDER
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·May 16, 2017
UNKNOWN COPELAND SHOULDER GLENOID COMPONENT
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code HSD·July 5, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 10, 2013
DXTEND GLENOSPHERE ECC D38MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.S.-SAINT PRIEST 3003895575·Product code KWS·September 2, 2014
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
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
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