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17,956 catalysts · 4,728 grant · 3,288 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
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17,956 catalysts · 4,728 grant · 3,288 8k filing · 2,606 approval · 2,051 device 510k · 1,649 device recall · 1,418 device pma
MH grant. $18,270,924. PI: Laura Thi Germine
HL grant. $1,525,500. PI: Rachel Klapper Zwick
GM grant. $300,721. PI: Joanna L Kelley
Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: TELIX. Form: POWDER. Route: INTRAVENOUS
Product code: OMP. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: SFR. Advisory committee: Cardiovascular. Type: Traditional
Product code: QGQ. Advisory committee: Orthopedic. Type: Traditional
Product code: FAJ. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: LYX. Advisory committee: Unknown. Type: Traditional
Product code: OLO. Advisory committee: Neurology. Type: Traditional
Product code: MXA. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Special
Product code: PDU. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QYI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LWS. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: PNF. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Advisory committee: OP. Decision: APPR
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes — Reason: Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride. — Status: Ongoing
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 — 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
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock — Reason: Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume. — Status: Ongoing
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 — 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
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 — 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
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 — 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
FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES. — Reason: The fastening post hardware could loosen allowing the fastening post to detach from the cot — Status: Ongoing
TENACIO Pump without InhibiZone; UPN: 72404420; — Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties. — Status: Ongoing
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