13 results
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35ms
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Sources: EU EUDAMED, US FDA
THE KIRSCHNER UNIVERSAL POWER TOOL SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ERA ANGLE 3.25MM IMP MICRO HEAD 13X1MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108020·Designed for both transitional and long-term de...
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083011499·Fixed, 4 electrode, MPB, 2-5-2mm electrode spacing
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00673978079318·TEMPLATE 901-455 24MM
Bone Expander
FDA UDI
BICON, LLC·00813110025999·5.5mm Bone Expander
ACCUWELL TSH, MODEL KAW-TSH-960
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 5, 2021
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·October 10, 2019
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code DCN·November 17, 2010
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