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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
Product code: QOF. Advisory committee: Microbiology. Type: Traditional
Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: KRD. Advisory committee: Cardiovascular. Type: Special
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: QAI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: ESW. Advisory committee: General, Plastic Surgery. Type: Special
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: NVZ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: OAE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVY. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare. — Reason: Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy. — Status: Ongoing
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing
FlexLab (FLX); Version: FLX-217-40; — Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes — Status: Ongoing
FlexLab (FLX); Version: FLX-217-10; — Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes. — Status: Ongoing
Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL
Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL
Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ELW. Advisory committee: Dental. Type: Traditional
Product code: HBE. Advisory committee: Neurology. Type: Traditional
Product code: FRG. Advisory committee: General Hospital. Type: Abbreviated
Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: OMB. Advisory committee: Neurology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: PCI. Advisory committee: Microbiology. Type: Traditional
Product code: GXY. Advisory committee: Neurology. Type: Abbreviated
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: PHX. Advisory committee: Orthopedic. Type: Traditional
Product code: MBH. Advisory committee: Orthopedic. Type: Traditional
Product code: SGJ. Advisory committee: Radiology. Type: Direct
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: NPW. Advisory committee: CV. Decision: APPR
IntelliVue MP90. Product Number: M8010A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP30. Product Number: M8002A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Patient Monitor MX800. Product Number: 865240. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, — Reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. — Status: Ongoing