13 results
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18ms
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Sources: EU EUDAMED, US FDA
ENOXAPARIN TEST CARD
FDA 510(k)
FDA Class 2
·Hematology
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0133000·Assembly, Rod Reducer, Ratcheting
Oscar 2
FDA UDI
SUNTECH MEDICAL, INC.·10840935108795·
PEDIATRIC INGESTASCAN
FDA 510(k)
FDA Class 2
·Ophthalmic
WEISS RETINAL CANNULA
FDA 510(k)
FDA Class 1
·Ophthalmic
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL, INC.·Product code LMH·September 24, 2009
IN TOUCH EU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·August 15, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code JTC·February 29, 2008
9MM TI STRAIGHT RADIAL STEM 30MM-STERILE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code KWI·October 7, 2017
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 16G x 4 inch Product Number: 8881847035
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code FMI·October 8, 2004
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