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18,221 catalysts · 4,728 grant · 3,086 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,221 catalysts · 4,728 grant · 3,086 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: PFV. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NPW. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30
Penner Pacific Bathing Spa, Model Numbers 360020-1P — Reason: The device does not bear a unique device identifier. — Status: Ongoing
UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B63322 — 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 360020-1EP — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Change Healthcare Radiology Solutions software version 14.2.2 — Reason: Due to software issue, radiology reports may not be fully displayed when viewing. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306. — 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
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332. — 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
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244. — 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
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325. — 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
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478 — 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. CT 6000, Model Number: 728307. — 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
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256. — 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 760010-1, 770010-1 — Reason: The device does not bear a unique device identifier. — Status: Ongoing
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317 — 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
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