14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card
FDA 510(k)
FDA Class 2
·Clinical Toxicology
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000856724·IMPLANT 6240686 ANATOMIC 18X16X6MM
VERTE-STACK® Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994304933·IMPLANT 6240686 ANATOMIC 18X16X6MM
Anatomic PEEK™ Cervical Fusion System with Nanotechnology
FDA UDI
NANOVIS SPINE, LLC·00814216028198·ANATOMIC PEEK w/ Nano 18 x 16 x 6 x 4.6°
ANATOMIC PEEK CERVICAL FUSION SYSTEM
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994360533·IMPLANT 4240686 ANATOMIC C 18X16X 6MM
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
FDA 510(k)
FDA Class 2
·Immunology
M'ATH STD
FDA 510(k)
FDA Class 2
·Radiology
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·October 27, 2023
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 25, 2008
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code GAM·September 9, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 22, 2013
BD ULTRA-FINE¿INSULIN WITH SHORT NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON DE MEXICO·Product code FMI·May 14, 2018
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code NCD·February 2, 2016
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025