12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
FDA 510(k)
FDA Class 2
·Microbiology
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450090756·
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code DTB·November 9, 2006
NEUROEDGE INFUSION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION
FDA 510(k)
FDA Class 2
·Anesthesiology
PROTECTIV PLUS SAFETY I.V. CATHETERS
FDA Adverse Event
Malfunction
·ICU MEDICAL, INC.·Product code FOZ·May 28, 2025
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAM·March 26, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 21, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 31, 2008
JELCO PROTECTIV FEP STRAIGHT SAFETY CATHETER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code FOZ·November 27, 2024
1.85MM TI MATRIX SCREW SELF-TAPPING/4MM
FDA Adverse Event
Malfunction
·SYNTHES (USA)·Product code JEY·January 21, 2015
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