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22,570 catalysts · 4,728 grant · 4,332 device 510k · 3,606 8k filing · 3,175 approval · 2,000 device pma · 2,000 device recall
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22,570 catalysts · 4,728 grant · 4,332 device 510k · 3,606 8k filing · 3,175 approval · 2,000 device pma · 2,000 device recall
Product code: OLO. Advisory committee: Neurology. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DTM. Advisory committee: Cardiovascular. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: MOS. Advisory committee: Radiology. Type: Special
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: PEN. Advisory committee: Microbiology. Type: Special
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: QLY. Advisory committee: General Hospital. Type: Traditional
Product code: OCZ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: QOF. Advisory committee: Microbiology. Type: Dual Track
Product code: FGE. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MBI. Advisory committee: Orthopedic. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: EKX. Advisory committee: Dental. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Sponsor: CELLTRION. Form: INJECTABLE. Route: INJECTION
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: EBI. Advisory committee: Dental. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: SDT. Advisory committee: Anesthesiology. Type: Traditional
Product code: JAA. Advisory committee: Radiology. Type: Traditional
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Traditional
Product code: QME. Advisory committee: Cardiovascular. Type: Traditional
Product code: OLV. Advisory committee: Neurology. Type: Traditional
Product code: HTN. Advisory committee: Orthopedic. Type: Traditional
Product code: PKC. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Special
Product code: FMF. Advisory committee: General Hospital. Type: Special
Product code: SBF. Advisory committee: Neurology. Type: Special
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30. — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only, — Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers. — Status: Completed