20 results · 21ms · Sources: EU EUDAMED, US FDA

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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