13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier K-FILES
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6919053296·FILES PKG 6 31MM 30
BIOMET SCK KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MOSS MIAMI SPINAL SYSTEMS
FDA 510(k)
FDA Class 2
·Orthopedic
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
RAD-8
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·February 4, 2016
ENERGEN
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013
3DKNEE SYSTEM
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code HSH·May 28, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code CAW·March 19, 2014
OXYSURE
FDA Adverse Event
Injury
·OXYSURE·Product code DQA·March 19, 2014
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