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12,903 catalysts · 3,350 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
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12,903 catalysts · 3,350 8k filing · 2,377 grant · 2,035 approval · 1,373 device 510k · 1,000 device adverse event · 929 device pma
Sponsor: GLAND PHARMA LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: HARROW EYE. Form: SUSPENSION. Route: OPHTHALMIC
Product code: LJS. Advisory committee: General Hospital. Type: Special
Product code: MYN. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: LZA. Advisory committee: General Hospital. Type: Traditional
Product code: LFX. Advisory committee: Microbiology. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OLZ. Advisory committee: Neurology. Type: Traditional
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor — Reason: Customer complaints of Pressio monitor rebooting. — Status: Ongoing
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001; — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339, — Reason: Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. — Status: Ongoing
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400240; Navigation, 4.5mm Tap, REF: PC2-400245; Navigation, 4.5mm Dual Lead Tap, REF: PC2-400345; Navigation, 5.5mm Dual Lead Tap, REF: PC2-400355 — Reason: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only. — Status: Ongoing
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. — Reason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. — Status: Ongoing
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover. — Reason: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. — Status: Ongoing
GM grant. $74,632. PI: Jingyi Luo
NR grant. $49,538. PI: La-Urshalar Beaushenique Brock
GM grant. $75,052. PI: Kristy Rochon
Sponsor: GENMAB US, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: RISING. Form: SOLUTION. Route: INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Sponsor: RISING. Form: TABLET. Route: ORAL
Sponsor: ASCENT PHARMS INC. Form: CAPSULE. Route: ORAL
Sponsor: HETERO LABS LTD III. Form: TABLET. Route: ORAL
Sponsor: KRAMER. Form: SHAMPOO. Route: TOPICAL
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: INJECTION
Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: AZURITY. Form: SOLUTION. Route: ORAL
Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION
Sponsor: ARROWHEAD. Form: SOLUTION. Route: SUBCUTANEOUS
Product code: NFT. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: GXQ. Advisory committee: Neurology. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Traditional
Product code: NKB. Advisory committee: Orthopedic. Type: Traditional
Product code: HRS. Advisory committee: Orthopedic. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: NHA. Advisory committee: Dental. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: HIS. Advisory committee: Obstetrics/Gynecology. Type: Abbreviated
Product code: QRX. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: LGZ. Advisory committee: General Hospital. Type: Traditional
Product code: DQA. Advisory committee: Cardiovascular. Type: Traditional
Product code: DXH. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR
Supplement type: Normal 180 Day Track No User Fee. Product code: QAN. Advisory committee: CV. Decision: APPR
Supplement type: 135 Review Track For 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: APPR
HemosIL SynthAFax. Partial Thromboplastin Time Tests. — Reason: Recalled lots were manufactured with double the amount of preservative concentration. — Status: Ongoing
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD Audio Driver Officially Released by HP (audio driver version 6.0.9484.1) — Reason: When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing. — Status: Ongoing