12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814527·GENUMEDI SAND SIZE I
AXSOS
FDA UDI
Stryker GmbH·07613154485451·Metal Base - Instruments
Varicella-Zoster Virus / VZV IgG IFA Slide Only Kit
FDA UDI
Hemagen Diagnostics, Inc.·G5229028011·For the detection and titration of antibodies t...
ORTHO SUMMIT TM SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·December 16, 1999
MPS M ELECTRODE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABS BLOWER, ABS NOZZLE, MODEL 1001
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 30, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 9, 2013
SENSIA SR
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NVZ·November 18, 2010
Achieva 1.5T Conversion
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023
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