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19,296 catalysts · 4,728 grant · 3,635 8k filing · 2,674 approval · 2,394 device 510k · 1,898 device recall · 1,679 device pma
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19,296 catalysts · 4,728 grant · 3,635 8k filing · 2,674 approval · 2,394 device 510k · 1,898 device recall · 1,679 device pma
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E, — Reason: Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging. — Status: Ongoing
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds. — Reason: Potential for fraying on the body support strap. — Status: Ongoing
AI grant. $35,157. PI: Caleb Buerger
Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL
Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS
Sponsor: RELIANCE LIFE SCI. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: GENENTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: MADRIGAL. Form: TABLET. Route: ORAL
Sponsor: MADRIGAL. Form: TABLET. Route: ORAL
Sponsor: MADRIGAL. Form: TABLET. Route: ORAL
Sponsor: BOEHRINGER INGELHEIM. Form: TABLET. Route: ORAL
Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: AMNEAL PHARMS LLC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL
Sponsor: IPSEN. Form: CAPSULE. Route: ORAL
Sponsor: SHIELD TX. Form: CAPSULE. Route: ORAL
Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL
Sponsor: POWDER PHARMS. Form: SYSTEM. Route: INTRADERMAL
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Special
Product code: KGN. Advisory committee: Unknown. Type: Traditional
Product code: KTT. Advisory committee: Orthopedic. Type: Traditional
Product code: DRE. Advisory committee: Cardiovascular. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: FAD. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NEZ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: CBK. Advisory committee: Anesthesiology. Type: Traditional
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQY. Advisory committee: Cardiovascular. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: KTI. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: DFH. Advisory committee: Immunology. Type: Traditional
Product code: DQK. Advisory committee: Cardiovascular. Type: Special
Product code: FRO. Advisory committee: Unknown. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: CJE. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: JEY. Advisory committee: Dental. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Abbreviated
Product code: PNE. Advisory committee: Cardiovascular. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: DQD. Advisory committee: Cardiovascular. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Special
Product code: NUC. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: JWH. Advisory committee: Orthopedic. Type: Traditional
Product code: NQQ. Advisory committee: Radiology. Type: Traditional
Product code: NEU. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: MUJ. Advisory committee: Radiology. Type: Traditional