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23,784 catalysts · 5,000 device 510k · 4,728 grant · 3,915 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
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23,784 catalysts · 5,000 device 510k · 4,728 grant · 3,915 approval · 3,350 8k filing · 2,000 device pma · 2,000 device recall
ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 41336 7 — Reason: cGMP Deviations — Status: Terminated
CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9 — Reason: cGMP Deviations — Status: Terminated
ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 — Reason: cGMP Deviations — Status: Terminated
HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC 8 45717 01072 6 — Reason: cGMP Deviations — Status: Terminated
LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL mL) per jug, Distributed By: Bob Barker Company, Inc., 7925 Purfoy Road, Fuquay-Varina, NC 27526. NDC: 53247-124-02 — Reason: CGMP violations. — Status: Ongoing
Product code: MPA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Traditional
Product code: IZF. Advisory committee: Radiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Special
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Abbreviated
Product code: MRW. Advisory committee: Unknown. Type: Special
Product code: QRA. Advisory committee: Neurology. Type: Special
Product code: EHD. Advisory committee: Dental. Type: Traditional
Product code: JOJ. Advisory committee: General Hospital. Type: Special
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: CGX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional
Product code: NEZ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MQV. Advisory committee: Orthopedic. Type: Special
Product code: SDP. Advisory committee: Hematology. Type: Direct
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QMV. Advisory committee: Microbiology. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: LOD. Advisory committee: Orthopedic. Type: Traditional
Product code: KOI. Advisory committee: Anesthesiology. Type: Traditional
Product code: LZO. Advisory committee: Orthopedic. Type: Special
Product code: EIH. Advisory committee: Dental. Type: Traditional
Product code: JWY. Advisory committee: Microbiology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Sponsor: BRACCO. Form: INJECTABLE. Route: INJECTION
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QQX. Advisory committee: Microbiology. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: MAX. Advisory committee: Orthopedic. Type: Traditional
Product code: KLA. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Product code: OHT. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OAB. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: PLF. Advisory committee: Orthopedic. Type: Abbreviated
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: PNG. Advisory committee: Gastroenterology, Urology. Type: Traditional