11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COBAS U411 TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
FDA 510(k)
FDA Class 2
·General Hospital
SCI-PHARM POST SECURE
FDA 510(k)
FDA Class 2
·Dental
EDWARDS ESHEATH INTRODUCER SET
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 6, 2021
EDWARDS TF SHEATH UNKNOWN
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·October 30, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 6, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 16, 2014
SAGITTAL BLADE 25.0X1.27X100MM
FDA Adverse Event
Malfunction
·STRYKER IRELAND LTD.·Product code GFA·April 5, 2011
EDWARDS TRANSCATHETER INTRODUCER SHEATH
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPT·December 11, 2019
NEEDLE FILTER BLUNT FILL 18X1-1/2
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 17, 2020
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