72 results
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12ms
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Sources: EU EUDAMED, US FDA
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
FDA Recall
Open, Classified
·Brainlab AG Olof-Palme-Str. 9 Munich Germany·Product code LLZ·February 10, 2025
OnGuard2 CSTD Bag Adaptor SP A Chemfort CSTD Product, Product code MG412143
FDA Recall
Open, Classified
·SIMPLIVIA HEALTHCARE LTD. NORTH IND. ZONE, (MIGADA PLANT) NORTH IND. ZONE PoBOX·Product code ONB·March 8, 2022
Puritan Bennett 980 Series Ventilator
FDA Recall
Open, Classified
·Medtronic formerly Covidien Michael Collins Road, Mervue Ind. Park Galway Ireland·Product code CBK·March 25, 2022
(1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
FDA Recall
Open, Classified
·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·January 23, 2025
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
FDA Recall
Open, Classified
·LUMENIS, LTD. Yokneam Ind. Park 6, Ha-Kidma Yokne'Am Ilit Israel·Product code GEX·July 22, 2025
Model Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS-710CW, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS.005, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_B_D_VIR3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SM_40HF_BDC3, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
SED URS LP, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Sedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery Mobile X-Ray System REF Soltus 500
FDA Recall
Open, Classified
·SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain·Product code IZL·August 12, 2022
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025
Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)
FDA Recall
Open, Classified
·SEDECAL SA Pelaya, 9 Pol. Pol. Ind. Rio De Janeiro Algete Spain·Product code IZL·June 10, 2025