22 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TENSION SLEEVE 5mm
FDA UDI
Aktormed GmbH·04260463843651·
VITALA CONTINENCE CONTROL DEVICE
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ELECSYS CA 19-9 CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLEURX LOCKABLE DRAINAGE LINE SET
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·April 2, 2026
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·November 5, 2018
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·November 5, 2018
BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·March 27, 2019
BD INTIMA II¿ IV CATHETER PRN ADAPTER
FDA Adverse Event
Malfunction
·BD (SUZHOU)·Product code FOZ·December 13, 2018
CORAIL STEM KAR16 HAC
FDA Adverse Event
Injury
·3003895575 DEPUY FRANCE·Product code LZO·June 3, 2013
EPIC II CRITICAL CARE BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 1, 2011
ACRYSOF TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MJP·August 22, 2008
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·September 26, 2025
INTIMA-II Y 22GAX1.00IN PRN/EC SLM
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·October 15, 2020
PLEURX
FDA Adverse Event
Malfunction
·CAREFUSION, INC·Product code DWM·June 2, 2025
CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·March 24, 2016
MECTA-C CERVICAL PLATE - SCREW
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·August 2, 2017
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 11, 2016
MECTA-C CERVICAL PLATE VARIABLE SELF-DRILLING SCREW DIAM. 4X16MM (2X)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code KWQ·January 15, 2016