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21,720 catalysts · 4,728 grant · 4,110 device 510k · 3,126 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
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21,720 catalysts · 4,728 grant · 4,110 device 510k · 3,126 8k filing · 3,118 approval · 2,000 device pma · 2,000 device recall
Product code: SAQ. Advisory committee: General, Plastic Surgery. Type: Special
Product code: KPS. Advisory committee: Radiology. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Sponsor: NOVO. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HAW. Advisory committee: Neurology. Type: Traditional
Product code: MNR. Advisory committee: Anesthesiology. Type: Special
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: FRC. Advisory committee: General Hospital. Type: Traditional
Product code: LCO. Advisory committee: Hematology. Type: Traditional
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL
Sponsor: AVANTHI INC. Form: TABLET. Route: ORAL
Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL
Sponsor: ABHAI LLC. Form: TABLET. Route: ORAL
Sponsor: ALEMBIC. Form: TABLET. Route: ORAL
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3 — Reason: CGMP Deviations: lack of adequate release testing. — Status: Ongoing
First Aid Beauty Ultra Repair Cream, colloidal oatmeal 0.5%, Coconut Vanilla, Net Wt. 396.8 g (14 OZ), DISTR. BY: First Aid Beauty LTD, Newton, MA, 02458, UPC 8 15517 02955 6 — Reason: CGMP Deviations; product intended for quarantine was inadvertently distributed — Status: Ongoing
FOUZEE SugarLin HERBAL FORMULA capsules, 180 capsules per bottle, Sold and Distributed by Shoppers-Plaza, Hawthorne, CA 90250. Product of India. UPC 8 26656 69047 7 — Reason: Marketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide — Status: Ongoing
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. — Reason: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet — Status: Completed
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SAH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: QYT. Advisory committee: Microbiology. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: NOVARTIS. Form: CAPSULE. Route: ORAL
Sponsor: VERTEX PHARMS INC. Form: TABLET. Route: ORAL
Sponsor: SOMERSET THERAPS LLC. Form: INJECTABLE. Route: INJECTION
Product code: IMK. Advisory committee: Physical Medicine. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: KWS. Advisory committee: Orthopedic. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: QYA. Advisory committee: Microbiology. Type: Traditional
Product code: MCW. Advisory committee: Cardiovascular. Type: Special
Product code: NBW. Advisory committee: Clinical Chemistry. Type: Traditional
Sponsor: NOVO NORDISK INC. Form: SOLUTION. Route: SUBCUTANEOUS