23 results · 22ms · Sources: EU EUDAMED, US FDA

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Rover

FDA 510(k)
FDA Class 2 ·Radiology

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113554·IMPLANT BLADE 5.2MM (BX/5)

NARKOMED MRI , NM-MRI

FDA 510(k)
FDA Class 2 ·Anesthesiology

SURECAN SAFETY HUBER NEEDLE INFUSION SETS

FDA 510(k)
FDA Class 2 ·General Hospital

EON 16 - CHANNEL RECHARGEABLE IPG

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 3, 2011

CLARION

FDA Adverse Event
Injury ·ADVANCED BIONICS LLC·Product code MCM·October 17, 2008

IMMULITE 2000 PROSTATE SPECIFIC ANTIGEN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code MTF·July 2, 2013

UNK - RESORBABLE IMPLANTS

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GXR·May 5, 2020

UNK - SYNPOR IMPLANTS

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code FTM·May 5, 2020

UNK - PLATES: MATRIXMIDFACE

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 5, 2020

UNK - RESORBABLE IMPLANTS

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GXR·May 5, 2020

UNK - RESORBABLE IMPLANTS

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code GXR·May 5, 2020

UNK - PLATES: MATRIXMIDFACE

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 5, 2020

UNK - PLATES: MATRIXMIDFACE

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 5, 2020

UNK - PLATES: CMF

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·May 5, 2020

ROD, FIXATION, INTRAMEDULLARY

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·May 14, 2018

Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.

FDA Recall
Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

FDA Recall
Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion

FDA Recall
Terminated ·Genesis BPS, LLC.·Product code BRZ·July 17, 2014

ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2 REUSABLE, ATAR-MDT2S-A, DK BLUE 30CM REUSABLE, ATAR-MDT2S-V WHITE 30CM REUSABLE, ATAR-MDTL REUSABLE, ATAR-MDTR REUSABLE, ATAR-R REUSABLE, ATAR-R T4P REUSABLE, ATAR-R1 REUSABLE, ATAR-RL REUSABLE, ATAR-T REUSABLE, ATAR-V WHITE REUSABLE, ATAR-V2 REUSABLE, XI.A DARK BLUE REUSABLE, XI.MDT REUSABLE, XI.R REUSABLE, XI.V WHITE, REUSEABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker

FDA Enforcement
Class I ·Terminated·Oscor, Inc.·July 19, 2017