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18,261 catalysts · 4,728 grant · 3,126 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
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18,261 catalysts · 4,728 grant · 3,126 8k filing · 2,639 approval · 2,188 device 510k · 1,786 device recall · 1,536 device pma
Sponsor: SHANGHAI HENLIUS BIOTECH. Form: INJECTABLE. Route: INJECTION
Product code: LYC. Advisory committee: Dental. Type: Traditional
Product code: HWC. Advisory committee: Orthopedic. Type: Traditional
Product code: NXC. Advisory committee: Dental. Type: Special
Product code: SFK. Advisory committee: Neurology. Type: Traditional
Product code: QJI. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: LPH. Advisory committee: Orthopedic. Type: Traditional
Product code: KPI. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: FPA. Advisory committee: General Hospital. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: PWB. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EBF. Advisory committee: Dental. Type: Traditional
Product code: DQX. Advisory committee: Cardiovascular. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: QRS. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: GWM. Advisory committee: Neurology. Type: Traditional
Product code: NTK. Advisory committee: Dental. Type: Traditional
Product code: PZM. Advisory committee: Pathology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: HET. Advisory committee: Obstetrics/Gynecology. Type: Traditional
Product code: NRY. Advisory committee: Cardiovascular. Type: Special
Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30
Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30
Supplement type: Special (Immediate Track). Product code: LKK. Advisory committee: HO. Decision: APPR
Supplement type: Panel Track. Product code: OZP. Advisory committee: CH. Decision: APPR
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: PMP. Advisory committee: NE. Decision: OK30
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