12 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
iHealth Clinical Digital Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
NONINVASIVE BLOOD PRESSURE MEASUREMENT SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·November 16, 2023
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
ARTHROSCOPY PACK, COMPONENT WITHIN
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code LRP·October 16, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011
RESTORE
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 2, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
HANDPIECE MICS
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·March 4, 2019
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