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19 catalysts · 8 device 510k · 6 device pma · 4 device recall · 1 approval
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19 catalysts · 8 device 510k · 6 device pma · 4 device recall · 1 approval
Sponsor: SECURA. Form: CAPSULE. Route: ORAL
Supplement type: 30-Day Notice. Product code: MOM. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NVN. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: MHY. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701 — Reason: Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles — Status: Ongoing
TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 955515, 955702, 955631 — Reason: Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted — Status: Ongoing
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-DI code: 07350137520081 Inserter Adapter OTD REF 30-158 Model Number: 1004 UDI-DI code: 07350137520098 The Inserter Adapters are intended to be attached to a Cup Inserter Tool. The Cup Inserter Tool (impactor) is intended to be tracked by and navigated to orient and position the hip implant cup correctly relative to preoperative planned position and orientation. — Reason: Due to a weld breakage between the pin and inserter holder of the Inserter Adapter. — Status: Ongoing
PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 — Reason: Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure — Status: Ongoing
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: NUH. Advisory committee: Neurology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: QYE. Advisory committee: Cardiovascular. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: FRN. Advisory committee: General Hospital. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QLX. Advisory committee: Microbiology. Type: Traditional