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18,618 catalysts · 4,728 grant · 3,674 8k filing · 2,621 approval · 2,129 device 510k · 1,725 device recall · 1,490 device pma
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18,618 catalysts · 4,728 grant · 3,674 8k filing · 2,621 approval · 2,129 device 510k · 1,725 device recall · 1,490 device pma
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds — Reason: Potential packaging failures, which could lead to a breach in the sterile barrier. — Status: Ongoing
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. — Reason: Issue with software algorithm which may lead to overpressure events. — Status: Ongoing
DK grant. $686,129. PI: Markus Grompe
DE grant. $419,375. PI: Kelly Christine Rice
NS grant. $126,900. PI: Eddy Albarran
EY grant. $76,120. PI: Sofia Krasovskaya
AI grant. $33,538. PI: Alexandra Tabachnikova
DE grant. $78,840. PI: Hagar Kenawy
NS grant. $674,950. PI: ZHIGANG HE
DE grant. $435,875. PI: Santiago Orrego
HL grant. $49,538. PI: Vasundhara Singh
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: B BRAUN. Form: INJECTABLE. Route: INJECTION
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL
Product code: LOX. Advisory committee: Cardiovascular. Type: Traditional
Product code: JXI. Advisory committee: Neurology. Type: Traditional
NS grant. $120,582. PI: Kiah Hardcastle
Sponsor: GLENMARK PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: SUN PHARM. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: AMTA. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: DSA. Advisory committee: Cardiovascular. Type: Special
CA grant. $87,964. PI: Katherine Ismei Zhou
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: HQ SPECLT PHARMA. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
AR grant. $15,000. PI: JOY Y WU
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: ALKEM LABS LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: ORAL
Sponsor: BAUSCH AND LOMB. Form: GEL. Route: OPHTHALMIC
Sponsor: UMEDICA. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL