39 results · 26ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Enforcement
Class II ·Terminated·Terumo BCT, Inc.·November 22, 2017

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

FDA Recall
Terminated ·Terumo BCT, Inc.·Product code JQC·October 20, 2017

CoRoent

FDA UDI
Nuvasive, Inc.·00887517563705·CoRoent Ant TLIF PEEK, 10x13x34mm 0°

MOLT PERIOSTEAL ELEVATOR

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896093928·MOLT PERIOSTEAL ELEVATOR DOUBLE ENDED TIPS #EX-1

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197265478·Martin Pelvimeter 34 cm,...

OBC-149 BREAST ARRAY COIL

FDA 510(k)
FDA Class 2 ·Radiology

RT-PLUS KNEE ADDITIONAL COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

UNKNOWN SOLITAIRE

FDA Adverse Event
Death ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021

UNKNOWN SOLITAIRE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021

UNKNOWN SOLITAIRE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code NRY·March 1, 2021

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 21, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALUE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 21, 2012

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·July 9, 2012

ASR UNI FEMORAL IMPL SIZE 45

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

PARADIGM INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code LZG·September 19, 2014

ATRIUM HERNIA REPAIR MESH

FDA Adverse Event
Injury ·ATRIUM·Product code FTL·May 20, 2011

PRIM SYM SET 2 CL W/FILTERTEK VALVE

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·February 14, 2012