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20,686 catalysts · 4,728 grant · 3,369 8k filing · 3,266 device 510k · 2,828 approval · 2,000 device pma · 2,000 device recall
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20,686 catalysts · 4,728 grant · 3,369 8k filing · 3,266 device 510k · 2,828 approval · 2,000 device pma · 2,000 device recall
UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C34520 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 362010-XL, 362010-1L, 360010-XL, 37000-1W, 360010-XW, 3700000-1W, 362010-2L, 36010-XWT, 370000-1L, 360010-2WT, 360000-1, 360010-XWSB, 360010-XLSB — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 860010-1L — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 560010-2L, 560010-XL, 560010-1L, 560010-XL — Reason: The device does not bear a unique device identifier. — Status: Ongoing
UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B23858 — Reason: Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts. — Status: Ongoing
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-2 — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311. — Reason: The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement. — Status: Ongoing
Product code: GXY. Advisory committee: Neurology. Type: Traditional
Product code: QBN. Advisory committee: Microbiology. Type: Traditional
Product code: PZL. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: HEB. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional
Product code: NQJ. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: QRA. Advisory committee: Neurology. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: DZL. Advisory committee: Dental. Type: Traditional
Product code: DZE. Advisory committee: Dental. Type: Traditional
Product code: HGX. Advisory committee: Obstetrics/Gynecology. Type: Special
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: GAT. Advisory committee: General, Plastic Surgery. Type: Special
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OUT. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MCX. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: SBB. Advisory committee: PA. Decision: OK30
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30
Supplement type: 30-Day Notice. Product code: MTF. Advisory committee: IM. Decision: OK30
Supplement type: Real-Time Process. Product code: FHW. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: LPB. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: OAE. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: PJY. Advisory committee: OR. Decision: APPR
Product code: FLE. Advisory committee: General Hospital. Type: Traditional
Product code: OHS. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JDQ. Advisory committee: Orthopedic. Type: Traditional
Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional