calendar
14,171 catalysts · 3,350 8k filing · 2,402 grant · 2,318 approval · 1,648 device 510k · 1,198 device recall · 1,125 device pma
next 91 dayslessmore
MonWedFri
14,171 catalysts · 3,350 8k filing · 2,402 grant · 2,318 approval · 1,648 device 510k · 1,198 device recall · 1,125 device pma
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE — Reason: The impacted lot may not meet the required tensile strength specification. — Status: Ongoing
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. Component: No — Reason: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. — Status: Ongoing
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic — Reason: GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions. — Status: Ongoing
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable — Reason: Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. — Status: Ongoing
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table — Reason: The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion. — Status: Ongoing
AA grant. $39,309. PI: Hanna Marie Hebden
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: HIKMA. Form: TABLET. Route: ORAL
Sponsor: TORRENT. Form: CAPSULE. Route: ORAL
Sponsor: DR REDDYS LABS SA. Form: TABLET. Route: ORAL-28
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, ORALLY DISINTEGRATING. Route: ORAL
Sponsor: UNITED THERAP. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: TEVA. Form: SUSPENSION, EXTENDED RELEASE. Route: SUBCUTANEOUS
Sponsor: METHODIST. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: AMNEAL. Form: CAPSULE. Route: ORAL
Sponsor: ACER. Form: FOR SUSPENSION. Route: ORAL
Sponsor: RUBICON. Form: CONCENTRATE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: TAKEDA PHARMS USA. Form: TABLET. Route: ORAL
Sponsor: UMEDICA. Form: TABLET. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: GLAXOSMITHKLINE LLC. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: GMQ. Advisory committee: Microbiology. Type: Traditional
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: QXQ. Advisory committee: General Hospital. Type: Traditional
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: SGE. Advisory committee: Neurology. Type: Special
Product code: PZP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PLV. Advisory committee: Dental. Type: Traditional