12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CARINA HOME
FDA 510(k)
FDA Class 2
·Anesthesiology
Trulife
FDA UDI
Trulife Limited·00645517726663·First Fit External Breast Form Size 05
LINK Instruments - Trial implants and size gauges
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575427741·Orthopaedic prosthesis instrument, reusable - G...
Durable BP Cuff
FDA UDI
SUNTECH MEDICAL, INC.·10840935104896·
FO NX Nail System
FDA UDI
FIELD ORTHOPAEDICS PTY LTD·09353903012535·0.6 Double-ended Trocar K-wire 70 mm 5/pkg
OPTIDOS
FDA 510(k)
FDA Class 2
·Radiology
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
FDA 510(k)
FDA Class 2
·Anesthesiology
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 26, 2013
TAUT ADAPT T 15MM BARIATRIC PORT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code GCJ·May 30, 2008
ASR ACETABULAR CUPS 58
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 6, 2011
QUADROX-ID PEDI
FDA Adverse Event
Death
·MAQUET CARDIOPULMONARY GMBH·Product code DTZ·March 8, 2021
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
FDA Recall
Terminated
·Roche Diagnostics Corp.·December 21, 2004