110 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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ClubMax Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Logolas Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Burstberry Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Atom Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
Spectrum Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code BRX·July 10, 2019
Maxim Laser Projection Series
FDA Recall
Open, Classified
·Gk Photonics Inc·Product code REA·July 10, 2019
bkActiv Ultrasound System 2300, Model numbers 2300-56 and 2300-66.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·November 30, 2023
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·September 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Recall
Open, Classified
·B-K Medical A/S Mileparken 34 Herlev Denmark·Product code IYN·October 9, 2025
Trilogy Evo Universal, Product number DS2000X11B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·July 26, 2021
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
Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·December 7, 2022
Philips Garbin Ventilator, Model Number 1058180B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·December 7, 2022
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes BT-20-0002, BT-20-0002A and BT-20-0002AP. The Life2000 ventilation system includes the Life2000 ventilator which has its individual label.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code CBK·May 29, 2024
Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B
FDA Recall
Open, Classified
·Philips Respironics, Inc.·Product code CBK·March 1, 2023