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18,536 catalysts · 4,728 grant · 3,086 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,536 catalysts · 4,728 grant · 3,086 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
Product code: BZE. Advisory committee: Anesthesiology. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Traditional
Product code: IRP. Advisory committee: Physical Medicine. Type: Traditional
Product code: FOZ. Advisory committee: General Hospital. Type: Traditional
Product code: KRO. Advisory committee: Orthopedic. Type: Traditional
Product code: GWO. Advisory committee: Neurology. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: FMF. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: KRH. Advisory committee: Cardiovascular. Type: Traditional
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
Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: PH HEALTH. Form: INJECTABLE. Route: INJECTION
Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION
Supplement type: 30-Day Notice. Product code: LWR. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPU. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NPT. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. — Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse. — Status: Ongoing
WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems. — Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse. — Status: Ongoing
WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to provide vascular and transseptal access for all WATCHMAN Left Atrial Appendage Closure Devices with Delivery Systems. — Reason: Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data, in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk (U.S. study) of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolemia, and partial upper airway collapse. — Status: Ongoing