768 results
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18ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ElectroMist product codes: 36-3310-04 - Product Usage: Electrode Conductivity Spray Solution.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019
Alpha Conducting solution product codes: 3310-25 ASCR - Product Usage: Electrode Conductivity Spray Solution.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019
ElectroMist product codes: 36-3310-60 - Product Usage: Electrode Conductivity Spray Solution.
FDA Recall
Terminated
·Pharmaceutical Innovations, Inc.·Product code GYB·June 19, 2019
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·November 7, 2018
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 26, 2018
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Enforcement
Class III
·Terminated·Ortho-Clinical Diagnostics·September 26, 2018
Radiesse, Injectable Implant - 1.3cc Syringe, Sterile, Sterilized Using Steam, Use Before 2013-01, Ref 8046M7, Lot 1024417, Manufactured by: BioForm Medical Inc, 4133 Courtney Rd #10 Franksville, WI 53126. Subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as masolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
FDA Recall
Terminated
·Merz Aesthetics, Inc.·Product code LMH·April 6, 2011
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood
FDA Recall
Terminated
·Roche Diagnostics Corporation·Product code KHE·September 24, 2018
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code QKP·April 14, 2021
VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usage: VITROS CREA Slides (Product Code 680 2584) - For in vitro diagnostic use only. VITROS Chemistry Products CREA Slides quantitatively measure creatinine (CREA) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JFY·July 11, 2018
VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage: VITROS Cl Slides (Product Code 684 4471) - For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code CGZ·July 11, 2018
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
10 GAUGE CEMENT DELIVERY CANNULA, CODE INTVM-CDC
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021
Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
FDA Recall
Terminated
·Product code LOD·July 26, 2016
1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code LOD·November 9, 2017
10 GAUGE DRILL, CODE INTVM-DRL
FDA Recall
Terminated
·BIOPSYBELL S.R.L. Via Aldo Manuzio N. 24 Via A.Manuzio n.24 Mirandola Italy·Product code LOD·March 22, 2021