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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
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17,936 catalysts · 4,728 grant · 3,603 8k filing · 2,587 approval · 1,933 device 510k · 1,543 device recall · 1,343 device pma
AI grant. $75,052. PI: Rachel Lucy Fay
Supplement type: Normal 180 Day Track No User Fee. Product code: OUT. Advisory committee: NE. Decision: APPR
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. — Reason: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. — Status: Ongoing
Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: HOSPIRA INC. Form: INJECTABLE. Route: INJECTION
Sponsor: GLAXOSMITHKLINE. Form: TABLET. Route: ORAL
Sponsor: SAGENT PHARMS INC. Form: INJECTABLE. Route: INJECTION
Sponsor: AUROBINDO PHARMA LTD. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS. Form: TABLET. Route: ORAL
Sponsor: MYLAN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: MSN. Form: TABLET. Route: ORAL
Sponsor: SPH ZHONGXI PHARM. Form: TABLET. Route: ORAL
Sponsor: UCB INC. Form: FOR SOLUTION. Route: ORAL
Sponsor: BRECKENRIDGE. Form: CAPSULE. Route: ORAL
Product code: PAB. Advisory committee: Microbiology. Type: Traditional
Product code: HRX. Advisory committee: Orthopedic. Type: Traditional
Product code: MZP. Advisory committee: Microbiology. Type: Traditional
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: IYE. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: EIA. Advisory committee: Dental. Type: Traditional
Product code: ITI. Advisory committee: Physical Medicine. Type: Traditional
Product code: LRK. Advisory committee: Dental. Type: Traditional
Supplement type: Normal 180 Day Track. Product code: LOK. Advisory committee: IM. Decision: APPR
Food Intolerance Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Vitamin D-Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Candida Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Organic Acids Profile Test Large — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Allergy Test IgE — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Allergy test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
GI Microbiome Profile XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Illegally Marketed — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
HPV Antigen Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Sperm Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Mycoplasma test, IgG and IgM — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Parasite Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Adrenal Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Neurotransmitters Plus — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Pollen Allergy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. — Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. — Status: Ongoing
Alcohol (ALC) Test Saliva — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Gut Microbiome Test XL — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Pet Allergy Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H; — Reason: Labeling contains claims that are not consistently present. — Status: Ongoing
Urinary Tract Infection Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Lactose Intolerance Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing