20 results
·
21ms
·
Sources: EU EUDAMED, US FDA
PELVICFLEXER EXERCISE DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040011317·Zirlux 16+ D2 95X10
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033320167·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033320174·
BETSEY JOHNSON
FDA UDI
FGX INTERNATIONAL INC.·00193033320181·
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SIII ALARM AMPLIFIER
FDA 510(k)
FDA Class 2
·Cardiovascular
16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 29, 2017
BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 3, 2017
16 X 100 MM X 8.5 ML BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
MEGA NEEDLE DRIVER INSTRUMENT
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·March 19, 2013
ACCU-CHEK FLEXLINK PLUS INFUSION SET
FDA Adverse Event
Injury
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·March 4, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·March 10, 2008
Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.
FDA Enforcement
Class II
·Terminated·Smith & Nephew, Inc.·February 17, 2016
REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·October 23, 2017
REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·October 23, 2017
REAMER SHAFT, AO FITTING BIXCUT Ø8,0X448 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code LXH·October 23, 2017
Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·June 29, 2022
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014