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

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VACUETTE EDTA K2 GEL TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Henry Schein

FDA UDI
HENRY SCHEIN, INC.·00304040008362·Zirlux 16+ A3 89x17x16

ACUFEX

FDA UDI
Smith & Nephew, Inc.·03596010023926·PCH BSKT SCP UPBTR CRVD R 1.3M

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100430·Caddie Lid, Adjustable Cross Links

Ocata Anterior Cervical System

FDA UDI
Kalitec Direct LLC·B07308K0120030·Removal Sleeve

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 11, 2021

ZIP

FDA UDI
AURORA SPINE, INC.·B5211040120430·ZIP 51 MIS Interspinous Fusion System, 12mm x 43mm

TRI-FIT FEMORAL STEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PELVEX HOMETRAINER

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 4, 2013

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 25, 2013

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 30, 2020

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 7, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·January 13, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 21, 2020

FREESTYLE

FDA Adverse Event
Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 14, 2007

ROD Ø5.5 SOFT CURV L35 TI

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NKB·March 20, 2013

TRANSTAR STRETCHER

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FPO·February 14, 2011

Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture

FDA Enforcement
Class II ·Terminated·Integrated Science Systems Inc·June 15, 2016

XIA 3 TITANIUM TORQUE WRENCH

FDA Adverse Event
Injury ·STRYKER SPINE BORDEAUX·Product code NKB·December 27, 2012