13 results
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19ms
·
Sources: EU EUDAMED, US FDA
VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00530271·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809845129·FOR MEN 20-30 MM HG KNEE HIGH OPEN TOE MEDIUM-L...
PREG-Q EARLY PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
FDA 510(k)
FDA Class 2
·Anesthesiology
ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010
RENAISSANCE 29 STRETCHER 8/00
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·April 11, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011
ON-Q PAINBUSTER
FDA Adverse Event
Other
·I-FLOW CORP.·Product code MEB·May 27, 2008
VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-GP75 TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC·Product code LON·January 14, 2019
REF H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 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