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21,247 catalysts · 4,728 grant · 3,640 device 510k · 3,350 8k filing · 2,970 approval · 2,000 device pma · 2,000 device recall
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21,247 catalysts · 4,728 grant · 3,640 device 510k · 3,350 8k filing · 2,970 approval · 2,000 device pma · 2,000 device recall
Product code: SBF. Advisory committee: Neurology. Type: Special
Product code: QUT. Advisory committee: Microbiology. Type: Special
Product code: DRS. Advisory committee: Cardiovascular. Type: Special
Product code: PYT. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: SAF. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Special
Product code: OMC. Advisory committee: Neurology. Type: Traditional
Product code: FFK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OUR. Advisory committee: Orthopedic. Type: Special
Product code: EKX. Advisory committee: Dental. Type: Traditional
Product code: LHI. Advisory committee: General Hospital. Type: Traditional
Product code: MQL. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: FFK. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FED. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: MLO. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: JKA. Advisory committee: Clinical Chemistry. Type: Traditional
Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL
Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL
Product code: OBJ. Advisory committee: Cardiovascular. Type: Traditional
Product code: QMI. Advisory committee: Microbiology. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: LFL. Advisory committee: Unknown. Type: Traditional
Product code: EXQ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: SAI. Advisory committee: Orthopedic. Type: Traditional
Product code: QEZ. Advisory committee: Cardiovascular. Type: Special
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: OVD. Advisory committee: Orthopedic. Type: Special
Product code: BSP. Advisory committee: Anesthesiology. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA LLC. Form: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Product code: PPN. Advisory committee: Cardiovascular. Type: Traditional
Product code: QEW. Advisory committee: Cardiovascular. Type: Special
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: FRESENIUS KABI USA. Form: SOLUTION. Route: INJECTION
Sponsor: ABBVIE. Form: SOLUTION. Route: ORAL
Sponsor: ABBVIE. Form: TABLET, EXTENDED RELEASE. Route: ORAL
Sponsor: EXELIXIS INC. Form: TABLET. Route: ORAL
CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc — Reason: Chemical contamination: presence of benzene — Status: Ongoing
Neupogen (filgrastim) For Injection, 300mcg/1 mL, 1 mL Single Dose Vials, Rx Only, For Subcutaneous or Intravenous Use Only, Sterile Solution - No Preservative, Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-530-01 (vial), NDC 55513-530-10 (box). — Reason: Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months. — Status: Ongoing
Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5185-93 — Reason: Failed Dissolution Specifications - low dissolution results — Status: Ongoing