76 results · 12ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 16, 2024

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.

FDA Recall
Open, Classified ·Augustine Temperature Management, LLC·Product code DWJ·December 4, 2024

Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier

FDA Recall
Open, Classified ·Breas Medical, Inc.·Product code NOU·June 2, 2022

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