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8,714 catalysts · 3,111 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
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8,714 catalysts · 3,111 8k filing · 1,702 grant · 1,000 device adverse event · 795 approval · 621 device 510k · 583 earnings
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing
Artegraft Vascular Graft; REF#: AG740; — Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. — Status: Ongoing
EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; — Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. — Status: Ongoing
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2" — Reason: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. — Status: Ongoing
GM grant. $224,737. PI: Elisabetta Liverani
NS grant. $110,118. PI: RODNEY P GUTTMANN
AI grant. $16,500. PI: TERRY L. SHEPPARD
AI grant. $457,875. PI: MELISSA J CAIMANO
AI grant. $596,318. PI: Neal Mathew Alto
AI grant. $649,484. PI: VLADIMIR P BADOVINAC
DK grant. $117,000. PI: VERA FRIDMAN
AI grant. $190,825. PI: Jessica Lin
GM grant. $142,182. PI: Kushal Seetharam
AI grant. $790,946. PI: Nathan Schmidt
AI grant. $435,875. PI: Vincent Tam
AI grant. $790,847. PI: Zandrea Ambrose
AI grant. $235,500. PI: Paul D Gershon
AI grant. $490,704. PI: Amanda Martinot
AI grant. $444,125. PI: Judith A Woodfolk
AI grant. $515,625. PI: Dmitry Lyumkis
GM grant. $462,500. PI: Yuuta Imoto
AI grant. $460,625. PI: YONG-RUI ZOU
AI grant. $729,189. PI: Adam Lee Bailey
AI grant. $195,750. PI: Liudi Tang
AI grant. $440,000. PI: SATISH N NADIG
GM grant. $160,566. PI: Mohammad Razavi Rizi
Sponsor: HYBIO. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: ACCORD. Form: EMULSION. Route: SUBCUTANEOUS
Sponsor: EMERGENT. Form: SPRAY, METERED. Route: NASAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: HYBIO. Form: INJECTABLE. Route: SUBCUTANEOUS
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: PFIZER. Form: TABLET. Route: ORAL
Sponsor: DR REDDYS LABS SA. Form: SOLUTION/DROPS. Route: OPHTHALMIC
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01 — Reason: cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits. — Status: Ongoing
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 — Reason: Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil — Status: Ongoing
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01. — Reason: Presence of Foreign Tablets/Capsules — Status: Ongoing
Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1363-7 — Reason: Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%. — Status: Ongoing
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313 — Reason: CGMP Deviations: product found to contain lead. — Status: Ongoing
Product code: QJP. Advisory committee: Cardiovascular. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Special
Product code: OUR. Advisory committee: Orthopedic. Type: Traditional
Product code: IYN. Advisory committee: Radiology. Type: Traditional
Product code: QBP. Advisory committee: General Hospital. Type: Traditional
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Traditional
Product code: SHE. Advisory committee: Radiology. Type: Direct
Supplement type: 135 Review Track For 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: APPR
Supplement type: 30-Day Notice. Product code: LMF. Advisory committee: SU. Decision: OK30
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30