14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M
FDA 510(k)
FDA Class 2
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780798·LEVAMED ACTIVE ANKLE SUP SLVR R I
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
FDA 510(k)
FDA Class 1
·General Hospital
THE KALIX IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
LINEAR 7.5 FR. 25CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·October 17, 2019
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 8, 2013
UNKNOWN ZIMMER KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·March 30, 2011
PINN CAN BONE SCREW 6.5MMX35MM
FDA Adverse Event
Malfunction
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 8, 2008
LINEAR 7.5 FR. 40CC IAB
FDA Adverse Event
Injury
·DATASCOPE CORP. - FAIRFIELD·Product code DSP·May 14, 2020
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·December 18, 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
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018