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18,447 catalysts · 4,728 grant · 3,312 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,447 catalysts · 4,728 grant · 3,312 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80 — Reason: The devices were shipped unsterilized. — Status: Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm — Reason: Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. — Status: Ongoing
BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
TENACIO Pump with InhibiZone; UPN: 72404429; — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. — Reason: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia. — Status: Ongoing
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ); — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 — Reason: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. — Status: Ongoing
GM grant. $260,288. PI: Dianna Arnoux-Whiteman
DK grant. $268,500. PI: Katherine Scovner Ravi
NS grant. $671,988. PI: Rajiv R Ratan
CA grant. $18,652. PI: Montserrat Soler
DE grant. $896,543. PI: Jianfu Chen
DK grant. $1,418,750. PI: David Michael Merrick
MH grant. $832,042. PI: Nicholas Charles Jacobson
DE grant. $358,823. PI: Hansel M. Fletcher
DK grant. $560,100. PI: Divij Verma
GM grant. $416,726. PI: Amanda B. Hummon
NR grant. $124,386. PI: SARA L DAVIS
HD grant. $1,127,814. PI: Maya Rossin-Slater
DK grant. $819,091. PI: Elizabeth Selvin
HD grant. $542,198. PI: Kelsey Holt
DK grant. $478,011. PI: Weining Lu
MH grant. $427,625. PI: Thomas A Blanpied
HD grant. $460,568. PI: Emily Graves Allen
DK grant. $2,086,360. PI: Tetsuo Shoda
DK grant. $307,508. PI: Yongxing James Liu
HL grant. $784,318. PI: PETROS KOUTRAKIS
DK grant. $2,477,577. PI: RICHARD E PRATLEY
AI grant. $80,224. PI: Jasper Lee