13 results
·
19ms
·
Sources: EU EUDAMED, US FDA
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70710271·BioQuick-Brackets McLaugh/Benn/Trev. .018" 5 ca...
Bone Screws
FDA UDI
ORTHOPEDIATRICS CORP.·00841132134344·EXTENDED CLEANING STYLET
S2 TIBIAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
FORTAFLEX SURGICAL SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
INTERSTIM
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 22, 2013
BLAKE DRAIN
FDA Adverse Event
Injury
·ETHICON·Product code KOG·April 27, 2011
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·February 28, 2018
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
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018