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41 catalysts · 23 approval · 11 device 510k · 5 device pma · 2 device recall
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41 catalysts · 23 approval · 11 device 510k · 5 device pma · 2 device recall
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
Supplement type: 30-Day Notice. Product code: NIM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QPT. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NIO. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NIP. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. — Reason: Due to an device without a premarket clearance being incorrectly package and distributed. — Status: Ongoing
CareLink Clinic, REF: MMT-7350 — Reason: Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. — Status: Ongoing