12 results
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25ms
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Sources: EU EUDAMED, US FDA
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750002283·VITROS Chemistry Products HPT Reagent
Bardia® Urethral Catheter Tray, Clear Plastic Catheter
FDA UDI
C. R. Bard, Inc.·00801741018404·Bardia® Urethral Catheter Tray, Clear Plastic C...
ACUMED
FDA UDI
Acumed LLC·10806378092909·Suture Anchor Drill Guide
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SINUSCOPE AND BACCESSORIES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ENDO FLIP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·March 24, 2014
POWERED PATIENT ROTATION BED
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code IKZ·October 23, 2012
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code NBW·September 6, 2007
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 19, 2022
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