172 results
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19ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 300900
FDA Recall
Open, Classified
·NeuMoDx Molecular Inc·Product code QLT·May 13, 2022
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
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Recall
Open, Classified
·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025
Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also far fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures
FDA Recall
Open, Classified
·Product code LOD·June 26, 2017
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
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A
FDA Recall
Open, Classified
·Heraeus Medical GmbH (Dental Division) Philipp-Reis-Str. 8 Wehrheim Germany·Product code LOD·December 9, 2025
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