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18,766 catalysts · 4,728 grant · 3,316 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
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18,766 catalysts · 4,728 grant · 3,316 8k filing · 2,667 approval · 2,309 device 510k · 1,852 device recall · 1,612 device pma
Supplement type: 30-Day Notice. Product code: NXW. Advisory committee: CV. Decision: OK30
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419 — Reason: IV sets may leak. — Status: Ongoing
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541 — Reason: IV sets may leak. — Status: Ongoing
The product is a handheld ultraviolet-C germicidal wand and contains a narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range. — Reason: The subject product emits unsafe level of UVC radiation (i.e., the product reaches the exposure limit for Risk Group 3 (high risk) in about 2.2 minutes). The product has a radiation safety defect, in that these radiation emissions are unnecessary to the accomplishment of the product s primary purpose of disinfecting objects and surfaces, and create a risk of skin and/or eye injuries to user and nearby persons. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 104-inch (2.6 meters), Product Code 2C8571 — Reason: IV sets may leak. — Status: Ongoing
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
Getinge 88-Series Washer- Disinfector. Model Number: 88-5. — Reason: Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. — Status: Ongoing
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 14-inch (35 centimeters), Product Code 2C8632 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8537 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 120-inch (3.0 meters), Non-DEHP, Product Code 2R8537 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 — Reason: IV sets may leak. — Status: Ongoing
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH. — Reason: Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa. — Status: Ongoing
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858 — Reason: IV sets may leak. — Status: Ongoing
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603 — Reason: IV sets may leak. — Status: Ongoing
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 102-inch (2.6 meters), Product Code 2C8593 — Reason: IV sets may leak. — Status: Ongoing
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM — Reason: To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap. — Status: Ongoing
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings. — Reason: Wound dressing may have foreign matter on the product. — Status: Ongoing
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519 — Reason: IV sets may leak. — Status: Ongoing
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634 — Reason: IV sets may leak. — Status: Ongoing
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the US. — Reason: Potential for breaches in the sterile barrier packaging, compromising sterility assurance. — Status: Ongoing
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425 — Reason: IV sets may leak. — Status: Ongoing
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
Sponsor: ABBVIE INC. Form: INJECTABLE. Route: INTRAVENOUS