12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VOCALIS AND VOCALIS SM
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975897·Trumpf Medical/Medizin Pad table top U24 H G U
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968806·Pad table top U24 H G U
Keystone HB
FDA UDI
Keystone Industries·H66860818161·HB VPS Putty Kit Fast Set base & catalyst 400g ea
PMMA disc
FDA UDI
Dentsply International Inc.·D00180818160·
DVNET MDV-PACS
FDA 510(k)
FDA Class 2
·Radiology
MINI MULTILEAF COLLIMATOR, MODEL KMI
FDA 510(k)
FDA Class 2
·Radiology
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 4, 2022
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 29, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 9, 2011
PUMP MMT-715NAS PRDGM INS V2.1 SK EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·July 23, 2008
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