510 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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25-LHP-828, HeNe Laser System, 35 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
25-LHP-928, HeNe Laser System, 25 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
N-LHP-928, HeNe Laser System, 35 mW
FDA Recall
Open, Classified
·PACIFIC LASERTECH, LLC·Product code RDW·March 1, 2024
AVANOS MIC-KEY SF Gastrostomy Feeding Tube
FDA Recall
Terminated
·Avanos Medical, Inc.·Product code KNT·July 29, 2020
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215
FDA Recall
Open, Classified
·Navinetics Inc·Product code HAW·February 26, 2024
Fresenius 2008T Series Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K2 Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Fresenius 2008K@home Series : Hemodialysis System
FDA Recall
Terminated
·Fresenius Medical Care Renal Therapies Group, LLC·Product code KDI·December 21, 2016
Newport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080 and N6-LPL-944-080 if sold as a power supply alone.
FDA Recall
Open, Classified
·Product code RFN·March 27, 2024
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
FDA Recall
Terminated
·Aesculap Implant Systems LLC·Product code LXH·November 18, 2020
ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
FDA Recall
Completed
·Aesculap Implant Systems LLC·Product code LXH·November 12, 2019
Stryker Xia 3 Anti-Torque Key Manual Surgical Instrument; Catalog Number 48237026. Product Usage: : Reusable instrument used to aid in the final tightening of the spinal construct. Intended Use: The Anti-Torque Key allows the Torque Wrench to align with the tightening axis and maximizing the torque needed to lock the implant assembly during final tightening of the spinal construct.
FDA Recall
Terminated
·Stryker Spine·Product code NKB·January 12, 2012
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
FDA Recall
Open, Classified
·FUJIFILM Healthcare Americas Corporation·Product code IZL·November 23, 2023
IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.
FDA Recall
Terminated
·AGFA Corp.·Product code LMD·December 11, 2007
Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·December 7, 2023
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·December 7, 2023
Picasso/Picasso Lite lasers Intended use: Dentistry.
FDA Recall
Terminated
·AMD Lasers, LLC·Product code GEX·April 15, 2010
MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHETIC_CT Material Numbers: 11060815
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 16, 2021
Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
FDA Recall
Open, Classified
·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis·Product code OWB·December 7, 2023