22 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040009642·Zirlux 16+ B2 100X10
TRI-CAM Dental Implant System
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950027293·TRI-CAM Temporary Abutment, Non-Engaging, 4.3 P...
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272473·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272466·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272480·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272497·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272503·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272510·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272459·
SIGHT STATION
FDA UDI
FGX INTERNATIONAL INC.·00193033272442·
ORTHOCEPH OC100 D
FDA 510(k)
FDA Class 2
·Dental
MAXITEX DUPLEX STERILE LATEX POWDERED SURGEON GLOVES WITH PROTEIN LABELING CLAIM (100 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CAPSUREFIXNOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·December 10, 2012
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·January 27, 2011
SUMMIT DUOFIX TAP SZ5 HI OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·August 12, 2015
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·MPRI·Product code DTB·March 19, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·March 4, 2011
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·August 14, 2014
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