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13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
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13,283 catalysts · 3,603 8k filing · 2,377 grant · 2,049 approval · 1,383 device 510k · 1,000 device adverse event · 930 device pma
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intended for use by trained ophthalmic surgeons in a variety of ophthalmic surgeries. Custom Pak is a collection of various ophthalmic surgical instruments and the necessary materials necessary to perform an ophthalmic surgical procedure. Component: N/A — Reason: Ophthalmic procedure packs may have incomplete seals affecting sterility. — Status: Ongoing
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. — Reason: A certain component of affected devices was not delivered within specification and contained impurities. — Status: Ongoing
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System. — Reason: Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results — Status: Ongoing
Sponsor: AMNEAL PHARMS NY. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: LILLY. Form: INJECTABLE. Route: INJECTION
Sponsor: ABBVIE. Form: SUSPENSION/DROPS. Route: OPHTHALMIC
Sponsor: RILEY CONSUMER. Form: CAPSULE. Route: ORAL
Sponsor: SHENZHEN TECHDOW. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: NOVARTIS. Form: TABLET. Route: ORAL
Sponsor: OTSUKA PHARM CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HIBROW HLTHCARE. Form: TABLET. Route: ORAL
Sponsor: BAJAJ. Form: SOLUTION. Route: ORAL
Sponsor: TARO. Form: TABLET. Route: ORAL
Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: MACLEODS PHARMS LTD. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: OBR. Advisory committee: Unknown. Type: Traditional
Product code: PMC. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Abbreviated
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OAS. Advisory committee: Radiology. Type: Traditional
Product code: QQI. Advisory committee: Cardiovascular. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OMC. Advisory committee: Neurology. Type: Traditional
Product code: NPL. Advisory committee: Dental. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Special
Product code: IYN. Advisory committee: Radiology. Type: Special
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: LYJ. Advisory committee: NE. Decision: APPR
Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PNJ. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: QVG. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: PHO. Advisory committee: GU. Decision: APPR
Supplement type: Special (Immediate Track). Product code: SAW. Advisory committee: SU. Decision: APPR