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12,459 catalysts · 3,431 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma
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12,459 catalysts · 3,431 8k filing · 2,370 grant · 1,843 approval · 1,245 device 510k · 1,000 device adverse event · 880 device pma
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a colorless end product. In phase two a second detergent in reagent 2 releases cholesterol from the LDL lipoproteins. This cholesterol reacts with cholesterol esterase, cholesterol oxidase and a chromogen system to yield a blue color complex which can be measured bichromatically at 540/660nm. The resulting increase in absorbance is directly proportional to the LDL-C concentration in the sample. — Reason: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL). — Status: Ongoing
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3 — Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing. — Status: Ongoing
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3 — Reason: Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing. — Status: Ongoing
Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: HIKMA. Form: SOLUTION. Route: ORAL
Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL
Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL
Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL
Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL
Sponsor: PHARM ASSOC. Form: SOLUTION. Route: ORAL
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: BEIGENE. Form: INJECTION. Route: SOLUTION
Sponsor: UCB INC. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: GLAXOSMITHKLINE. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: MSD MERCK CO. Form: POWDER. Route: INTRAVENOUS
Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: SHORLA. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: GLAXOSMITHKLINE. Form: SPRAY. Route: NASAL
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: MACLEODS PHARMS LTD. Form: CAPSULE. Route: ORAL
Sponsor: HIKMA. Form: INJECTABLE. Route: INJECTION
Product code: GEH. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: EMA. Advisory committee: Dental. Type: Traditional
Product code: CAW. Advisory committee: Anesthesiology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: QRL. Advisory committee: General, Plastic Surgery. Type: Special
Product code: QKQ. Advisory committee: Pathology. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: NIM. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MGB. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MKJ. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: MRA. Advisory committee: OR. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: MGB. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Product code: MER. Advisory committee: GU. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: NIP. Advisory committee: CV. Decision: APPR
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA — Reason: Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments — Status: Ongoing