13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE
FDA 510(k)
FDA Class 2
·Orthopedic
NA
FDA UDI
MEDTRONIC XOMED, INC.·00681490034692·PROSTHESIS 1133370 MOD CUP PISTON .4X4.0
HHM
FDA UDI
Oticon A/S·05707131261014·H100, MINIRITE 312 WL CNB HHM
DreamWear Full
FDA UDI
Respironics, Inc.·00606959046313·DreamWear Full Face Mask, Small Cushion, Small ...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613025199·Mayo-Harrington Scissors, Super Cut, Straight, ...
POWERED WHEELCHAIR, MODEL FR168W
FDA 510(k)
FDA Class 2
·Physical Medicine
RT200
FDA 510(k)
FDA Class 2
·Neurology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013
HEARTSTREAM FR2
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·June 16, 2011
Philips Respironics DreamWear Full Face Mask
FDA Enforcement
Class I
·Ongoing·Philips Respironics, Inc.·October 12, 2022
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
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015