26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMM HYPODERMIC NEEDLE SET
FDA 510(k)
FDA Class 2
·General Hospital
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070801·SECRET SKIN, SIZE XXL, NATUR, MICRO-MASSAGING P...
Zimmer
FDA UDI
TEDAN SURGICAL INNOVATIONS, L.L.C.·00843059118803·ZIMMER - SPINE MIS STERILIZATION TRAY-ACCESSORIES
TSI
FDA UDI
TEDAN SURGICAL INNOVATIONS, L.L.C.·00843059114959·STERILIZATION TRAY 1, ML-2008 & ML-2018
PANORAMA
FDA UDI
SPINECRAFT, LLC·00193082079351·PHANTOM ML STERILIZATION TRAY-ACCESSORIES (FOR ...
PC COATED FLUOROPLASTIC VENT TUBES
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
T2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 15, 2024
SPECTRUM IQ INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 20, 2023
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·April 24, 2023
SPECTRA WAVEWRITER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 5, 2026
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·April 22, 2013
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·April 15, 2011
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·July 3, 2008
NUTRILINE
FDA Adverse Event
Malfunction
·VYGON USA·Product code LJS·October 9, 2020
BATTERY H&PIECE/MOD FOR TRAUMA RECON SYS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code GEY·March 29, 2021
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·June 3, 2015
Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·March 19, 2014
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients within a defined coverage area.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·March 12, 2015
BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001934;
FDA Enforcement
Class II
·Ongoing·Beaver Visitec International, Inc.·September 4, 2024