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

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M SERIES PATIENT MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

Oticon

FDA UDI
Oticon A/S·05707131259479·NERA, KIT 13 DIR R H BE

ELECTRO FLO PERCUSSOR, MODEL 5000

FDA 510(k)
FDA Class 2 ·Anesthesiology

DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 28, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·February 27, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code NDN·March 1, 2013

VERTECEM V+ CEMENT KIT

FDA Adverse Event
Injury ·SYNTHES GMBH·Product code NDN·February 27, 2013

MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN

FDA Adverse Event
Injury ·MED SYSTEM, INC.·Product code BYI·September 21, 2018

OT ULTRALINK METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

ADAPTA SR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NVZ·June 16, 2011

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

FDA Enforcement
Class II ·Terminated·Ortho Development Corporation·May 21, 2014

INTELLIVUE MX500 PATIENT MONITOR

FDA Adverse Event
Death ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code MHX·December 4, 2023

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015