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19 catalysts · 8 device pma · 7 device 510k · 3 device recall · 1 approval
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19 catalysts · 8 device pma · 7 device 510k · 3 device recall · 1 approval
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Abbreviated
Product code: SFP. Advisory committee: Anesthesiology. Type: Traditional
Product code: MHX. Advisory committee: Cardiovascular. Type: Traditional
Product code: SAO. Advisory committee: Radiology. Type: Traditional
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: NJD. Advisory committee: Orthopedic. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: OAD. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MCM. Advisory committee: EN. Decision: APPR
Supplement type: 30-Day Notice. Product code: HQL. Advisory committee: OP. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MJO. Advisory committee: OR. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: PZK. Advisory committee: OP. Decision: APPR
Supplement type: 30-Day Notice. Product code: MFK. Advisory committee: OP. Decision: OK30
Supplement type: Special (Immediate Track). Product code: MKJ. Advisory committee: CV. Decision: APPR
This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities. — Reason: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used. — Status: Ongoing
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030; — Reason: The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority. — Status: Ongoing
Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. — Reason: Due to incorrect product label (Incorrect product name identified on outer packaging). — Status: Ongoing