105 results · 13ms · Sources: EU EUDAMED, US FDA

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ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·July 29, 2024

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·August 11, 2025

Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total protein in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097604

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·January 27, 2023

Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code CEK·September 20, 2021

The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

FDA Recall
Open, Classified ·Ge Healthcare·Product code RCC·May 8, 2020

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

Trilogy Evo Universal Ventilator, Model No. DS2000X11B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·July 16, 2024

Servo-n Ventilator System. Model Number: 6694800.

FDA Recall
Open, Classified ·Maquet Critical Care AB Rontgenvagen·Product code CBK·May 30, 2025

NovaStar TS, Standard elbow, Reusable, Material Numbers MP01579 (Size S), MP01580 (Size M), and MP01581 (Size L)

FDA Recall
Open, Classified ·Draeger Medical, Inc.·Product code CBK·January 23, 2023

Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·May 1, 2023

Ventilator HAMILTON-C6, PN: 160021

FDA Recall
Open, Classified ·Hamilton Medical AG Via Crusch 8 Bonaduz Switzerland·Product code CBK·May 15, 2024

Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024

Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

FDA Recall
Open, Classified ·Philips Respironics, Inc.·Product code CBK·October 7, 2024