calendar
20,434 catalysts · 4,728 grant · 3,350 8k filing · 3,122 device 510k · 2,796 approval · 2,000 device pma · 2,000 device recall
next 91 dayslessmore
MonWedFri
20,434 catalysts · 4,728 grant · 3,350 8k filing · 3,122 device 510k · 2,796 approval · 2,000 device pma · 2,000 device recall
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System — Reason: The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment. — Status: Ongoing
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187 — Reason: Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation. — Status: Ongoing
MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli. — Reason: Due to the likely presence of contamination in well(s). — Status: Ongoing
Product code: HSX. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: KQJ. Advisory committee: Hematology. Type: Special
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: OCL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: NFB. Advisory committee: Anesthesiology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: FTL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OWN. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FMI. Advisory committee: General Hospital. Type: Traditional
Sponsor: ALEMBIC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ACCORD HLTHCARE. Form: INJECTABLE. Route: INTRAVENOUS
Supplement type: 30-Day Notice. Product code: NIM. 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: OZD. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LZP. Advisory committee: OP. Decision: OK30
Supplement type: Real-Time Process. Product code: LSZ. Advisory committee: AN. Decision: APPR
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: QRF. Advisory committee: IM. Decision: APPR
Supplement type: 30-Day Notice. Product code: NKM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PYX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NIP. Advisory committee: CV. Decision: OK30
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery. — Reason: Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'. — Status: Ongoing
ZAP-X Radiosurgery System, Model: 300150 — Reason: If the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error message occurs after the automatic reduction of speed, a software defect could potentially lead the collimator to collide with patient shoulders or the patient table. — Status: Ongoing
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC010469; 6. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480; 7. TRAY 2 INTUBATION DRAWER, Kit Number ACC010480A; 8. ADULT INTUBATION, Kit Number ACC010540; 9. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593A; 10. DIFFICULT AIRWAY TRAY #1, Kit Number ACC010593B; 11. INTUBATION TRAY, Kit Number DYNDA1847A; 12. INTUBATION TRAY (ADULT), Kit Number DYNJAA245A. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. — Status: Ongoing
10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices. — Reason: Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway. — Status: Ongoing
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728. — Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended. — Status: Ongoing
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery. — Reason: Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'. — Status: Ongoing
One Step Sterile Lancet for Single Use (3 sizes): 06949517008861 30g 06949517008854 28g 06949517008847 23g The Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. — Reason: Due to incorrect/lack of Unique Device Identifier (UDI) codes. — Status: Ongoing
Product code: BZE. Advisory committee: Anesthesiology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: KRO. Advisory committee: Orthopedic. Type: Traditional
Product code: GWO. Advisory committee: Neurology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: KRH. Advisory committee: Cardiovascular. Type: Traditional
Sponsor: SECURA. Form: CAPSULE. Route: ORAL