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21,232 catalysts · 4,728 grant · 3,655 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
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21,232 catalysts · 4,728 grant · 3,655 8k filing · 3,435 device 510k · 2,886 approval · 2,000 device pma · 2,000 device recall
IntelePACS - InteleConnect / TechPortal — Reason: Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making. — Status: Ongoing
MONARCH Bronchoscope. Model Number: MBR-000211-B — Reason: Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks. — Status: Ongoing
Sponsor: ASTRAZENECA AB. Form: INJECTABLE. Route: INJECTION
Sponsor: MICRO LABS. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: ONG. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Special
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NEW. Advisory committee: General, Plastic Surgery. Type: Traditional
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 — Reason: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. — Status: Ongoing
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — Reason: Potential for anesthesia leakage. — Status: Ongoing
Sponsor: CSPC OUYI PHARM CO. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: LUPIN LTD. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: HIKMA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: STRIDES PHARMA INTL. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PHARMACYCLICS LLC. Form: CAPSULE. Route: ORAL
Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION
Sponsor: PHARMACYCLICS LLC. Form: SUSPENSION. Route: ORAL
Sponsor: LUPIN LTD. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: PHARMOBEDIENT. Form: CAPSULE. Route: ORAL
Sponsor: AMNEAL. Form: INJECTABLE. Route: INJECTION
Sponsor: BAUSCH AND LOMB INC. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Sponsor: PHARMACYCLICS LLC. Form: TABLET. Route: ORAL
Sponsor: PH HEALTH. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Sponsor: ACTAVIS ELIZABETH. Form: TABLET, FOR SUSPENSION. Route: ORAL
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: ONB. Advisory committee: General Hospital. Type: Special
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: PBF. Advisory committee: Orthopedic. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional