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13,623 catalysts · 3,312 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
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13,623 catalysts · 3,312 8k filing · 2,401 grant · 2,188 approval · 1,517 device 510k · 1,123 device recall · 1,026 device pma
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
MAMMOMAT Revelation; — Reason: There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only. — Status: Ongoing
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), temperature (TEMP), invasive pressure (IBP), Carbon Dioxide (CO2). The system capabilities include storing, displaying, analyzing and controlling such data afterwards. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. The system is intended to be used during patient transport inside and outside of the hospital environment. Component: No — Reason: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. — Status: Ongoing
Sponsor: ROBERTS OXYGEN CO INC. Form: GAS. Route: INHALATION
5008X CAREsystem +CLiC +CDX; — Reason: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled. — Status: Ongoing
Sponsor: PLIVA. Form: TABLET. Route: ORAL
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: BRISTOL-MYERS SQUIBB. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: CARNEGIE. Form: CAPSULE. Route: ORAL
Sponsor: AJENAT PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ. Form: EMULSION. Route: OPHTHALMIC
Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: NAVINTA LLC. Form: TABLET. Route: ORAL
Sponsor: BAYER HLTHCARE. Form: SPRAY, METERED. Route: NASAL
Sponsor: BIOVITRUM AB. Form: VIAL. Route: SUBCUTANEOUS
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GWO. Advisory committee: Neurology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: LYZ. Advisory committee: General Hospital. Type: Traditional
Product code: SAN. Advisory committee: Microbiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: MIR. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: Panel Track. Product code: LWR. Advisory committee: CV. Decision: APPR
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM — Reason: Between July 2024 and June 2025, Philips Azurion R3.0 systems with a FlexArm stand were shipped without the Source-to-Skin Distance (SSD) Spacer. The SSD spacer is necessary to meet the FDA minimum source-skin distance requirement of 38 cm for standard fluoroscopy applications. — Status: Ongoing
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Curad Quick Strip Fabric Bandages Containing 30 Bandages of 3/4" x 3", Medline Item Number CUR1930P — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe. — Status: Ongoing
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only — Reason: Screw may loosen or fallout of Hemodialysis system — Status: Ongoing
Quick Strip Plastic Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25600QS — Reason: Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product. — Status: Ongoing
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION
Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: INJECTABLE. Route: INJECTION
Sponsor: ELI LILLY AND CO. Form: INJECTABLE. Route: INJECTION
Sponsor: VIIV HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: AZURITY. Form: TABLET. Route: ORAL
Sponsor: CHANGZHOU PHARM. Form: TABLET. Route: ORAL