17 results
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19ms
·
Sources: EU EUDAMED, US FDA
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132080·Trial, TLIF, 27L OB CRV 7Deg, 8mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0132000·Rod Reducer, Axial, NIDO
HUB SPIN-LOC THREADED LOCKING OEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 9, 2021
VARIANT II TOTAL GHB
FDA 510(k)
FDA Class 2
·Hematology
TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2
FDA 510(k)
FDA Class 2
·Orthopedic
ULTRA DRIVE 6MM PLUG PULLER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022
BURRS
FDA Adverse Event
Malfunction
·MANSFIELD MANUFACTURING SITE·Product code HAB·March 20, 2013
INJECTOR, OPTIVANTAGE DH W/RFID
FDA Adverse Event
Injury
·LIEBEL-FLARSHEIM CO.·Product code IZQ·March 8, 2011
PULMONETIC
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 203/PULMONETIC SYSTEMS, INC·Product code CBK·March 14, 2008
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAT·March 9, 2022
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·March 9, 2022
HUB SPIN-LOC THREADED LOCKING OEM
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 19, 2021
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·August 15, 2017
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
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022