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22,708 catalysts · 4,728 grant · 4,646 device 510k · 3,316 8k filing · 3,239 approval · 2,000 device pma · 2,000 device recall
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22,708 catalysts · 4,728 grant · 4,646 device 510k · 3,316 8k filing · 3,239 approval · 2,000 device pma · 2,000 device recall
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01 — Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity. — Status: Ongoing
Product code: QAU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QJY. Advisory committee: General Hospital. Type: Special
Product code: PGY. Advisory committee: Radiology. Type: Abbreviated
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: KPI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Special
Product code: FBO. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HTN. Advisory committee: Orthopedic. Type: Special
Product code: JFB. Advisory committee: Physical Medicine. Type: Special
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: QPB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PTI. Advisory committee: General Hospital. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: OWW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Sponsor: BIOCON BIOLOGICS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: NOVEN PHARMS INC. Form: FILM, EXTENDED RELEASE. Route: TRANSDERMAL
Sponsor: NOVEN PHARMS INC. Form: SYSTEM. Route: TRANSDERMAL
Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: QWL. Advisory committee: Orthopedic. Type: Special
Product code: POV. Advisory committee: Hematology. Type: Traditional
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: AVYXA HOLDINGS. Form: POWDER. Route: INTRAVENOUS
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: JCX. Advisory committee: General, Plastic Surgery. Type: Special
Product code: PSY. Advisory committee: Pathology. Type: Traditional
Product code: KZH. Advisory committee: General Hospital. Type: Traditional
Product code: OAP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FEB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: HSN. Advisory committee: Orthopedic. Type: Traditional
Sponsor: PF PRISM CV. Form: TABLET. Route: ORAL
Sponsor: PF PRISM CV. Form: CAPSULE. Route: ORAL
Sponsor: REMPEX. Form: POWDER. Route: INTRAVENOUS
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INTRAVENOUS
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: MAI. Advisory committee: Orthopedic. Type: Special
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Special
Product code: GAP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION
THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 00818 1 — Reason: cGMP Deviations — Status: Terminated