22 results · 24ms · Sources: EU EUDAMED, US FDA

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S.I.N. Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391

FDA 510(k)
FDA Class 2 ·General Hospital

SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·January 8, 2021

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

SYNCHROMED EL

FDA Adverse Event
Injury ·RICE CREEK MFG·Product code LKK·June 14, 2013

COGNIS

FDA Adverse Event
Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 20, 2011

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Recall
Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.

FDA Enforcement
Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

KIT BD MAX EXT ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCH·June 21, 2022

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 4, 2022

BINAXNOW COVID-19 ANTIGEN SELF TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 4, 2022

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·August 14, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Death ·COOK VANDERGRIFT INC·Product code DRB·August 23, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·August 23, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·March 13, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·November 8, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DRB·February 12, 2024

LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET

FDA Adverse Event
Injury ·COOK VANDERGRIFT INC·Product code DQX·October 25, 2024