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23,058 catalysts · 4,728 grant · 4,703 device 510k · 3,486 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
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23,058 catalysts · 4,728 grant · 4,703 device 510k · 3,486 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
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
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com — 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
Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426, NDC 81284-411-05 — Reason: Discoloration — Status: Ongoing
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, 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
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com. — 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
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30. — 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
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022. — 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