27 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
FDA 510(k)
FDA Class 1
·Microbiology
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664215392·ULTRA SHEER 20-30 MM HG WAIST HIGH MATERNITY ME...
SafeGuide® Single
FDA UDI
DIVERSATEK HEALTHCARE, INC.·00816734023266·Disposable Over the Guidewire Esophageal Dilato...
DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITAL SIGNS MONITOR MODEL M3B
FDA 510(k)
FDA Class 2
·Cardiovascular
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·March 6, 2017
AV PLUS DX BIFURCATED BIPOLAR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DTB·January 13, 2014
2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·May 21, 2013
ADJUSTABLE PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·May 6, 2011
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·December 1, 2016
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 25, 2017
90 DEG CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·October 14, 2016
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·October 21, 2016
BIOMNET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·September 23, 2016
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·March 20, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 12, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·July 11, 2017
BIOMET MICROFIXATION FACIAL PLATING SYSTEM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 12, 2017
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·December 15, 2016
90 DEGREE CONTRA ANGLE SCREWDRIVER
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·January 16, 2017