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127 catalysts · 102 device recall · 14 approval · 10 device 510k · 1 device pma
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127 catalysts · 102 device recall · 14 approval · 10 device 510k · 1 device pma
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
PSA Test — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
Gut Microbiome Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing
8 in 1 STI Test Kit — Reason: Distribution without premarket approval/clearance. — Status: Ongoing