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14,350 catalysts · 3,312 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
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14,350 catalysts · 3,312 8k filing · 2,435 grant · 2,379 approval · 1,691 device 510k · 1,229 device recall · 1,158 device pma
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: SEG. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: EZY. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30
MC3 VitalFlow Console, REF 58100; Blood pump of ecmo — Reason: As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout. — Status: Ongoing
MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. — Reason: Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit open seals. — Status: Ongoing
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01; — Reason: It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy. — Status: Ongoing
Sponsor: ARCUTIS. Form: CREAM. Route: TOPICAL
Supplement type: Normal 180 Day Track No User Fee. Product code: NPU. Advisory committee: CV. Decision: APPR
Sponsor: APOTEX. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: TABLET. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: PATCH. Route: TOPICAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: HISAMITSU PHARM CO. Form: PATCH. Route: TOPICAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: HETERO LABS LTD V. Form: TABLET. Route: ORAL
Product code: SGB. Advisory committee: Neurology. Type: Direct
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: EXB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: INI. Advisory committee: Physical Medicine. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: MRJ. Advisory committee: OP. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; — Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. — Status: Ongoing
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 — Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). — Status: Ongoing
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT (Fecal Occult Blood Test) — Reason: A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17. — Status: Ongoing
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 — Reason: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC). — Status: Ongoing
Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract. — Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. — Status: Ongoing
Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS1), 3gAllergy Specific IgE Control Antibody (L2UNS2); Siemens Material Number (SMN): 10380875; Catalog Number: L2KUN6; — Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. — Status: Ongoing
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6; — Reason: The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge. — Status: Ongoing
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract. — Reason: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton. — Status: Ongoing
Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient). Pump, Tandem Mobi, Control-IQ/1010750, Pump, Tandem Mobi, Control-IQ, Replacement/1012719, Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501, Pump, Tandem Mobi, Control-IQ 7.7/1013655, Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656, Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700, Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081 — Reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: "Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped", which could result in hyperglycemia. — Status: Ongoing
Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I — Reason: The nasal feeding tube may be occluded — Status: Ongoing
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL