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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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14,268 catalysts · 3,350 8k filing · 2,402 grant · 2,350 approval · 1,681 device 510k · 1,204 device recall · 1,151 device pma
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
IntelliVue Patient Monitor MX700. Product Number: 865241. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Patient Monitor MX500. Product Number: 866064. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Patient Monitor MX850. Product Number: 866470. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK; — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing
NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP; — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing
IntelliVue MP2. Product Number: M8102A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP50. Product Number: M8004A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP80. Product Number: M8008A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue Patient Monitor MX100. Product Number: 867033. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP40. Product Number: M8003A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
Olympus OER-Elite — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing
IntelliVue Multi Measurement Server X2. Product Number: M3002A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP60. Product Number: M8005A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP5. Product Number: M8105A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing
IntelliVue MP20. Product Number: M8001A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing