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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
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17,746 catalysts · 4,639 grant · 3,603 8k filing · 2,587 approval · 1,903 device 510k · 1,500 device recall · 1,315 device pma
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06. — Reason: Failed Impurity/Degradation Specifications — Status: Ongoing
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10. — Reason: cGMP deviations: Temperature excursion during transportation. — Status: Ongoing
Sulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count bottles (NDC 51655-307-87), b) 10-count bottles (NDC 51655-307-53), c) 14-count bottles (NDC 51655-307-84), d) 20-count bottles (NDC 51655-307-20) Rx Only, Repackaged from Amneal Pharmaceuticals LLC. Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46203. — Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets. — Status: Ongoing
Product code: FRC. Advisory committee: General Hospital. Type: Special
Product code: LLZ. Advisory committee: Radiology. Type: Traditional
Product code: KNW. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Special
Product code: OOE. Advisory committee: Ophthalmic. Type: Special
Product code: MUH. Advisory committee: Dental. Type: Traditional
Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: QFG. Advisory committee: Clinical Chemistry. Type: Traditional
Product code: FET. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MVL. Advisory committee: Unknown. Type: Traditional
Product code: IZQ. Advisory committee: Cardiovascular. Type: Special
Product code: DYB. Advisory committee: Cardiovascular. Type: Special
Product code: FDF. Advisory committee: Gastroenterology, Urology. Type: Traditional
Supplement type: 30-Day Notice. Product code: OZD. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: QZI. Advisory committee: CV. Decision: APPR
Supplement type: Special (Immediate Track). Product code: MOM. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MKT. Advisory committee: MI. Decision: APPR
Supplement type: 30-Day Notice. Product code: MCN. Advisory committee: OB. Decision: OK30
Supplement type: 30-Day Notice. Product code: LMG. Advisory committee: SU. Decision: OK30
Supplement type: Normal 180 Day Track. Product code: OSR. Advisory committee: CV. Decision: APPR
Supplement type: Real-Time Process. Product code: MAQ. Advisory committee: MI. Decision: APPR
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Description: REDUCING CONVERTER 10/12MM TO 5MM Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: Aesculap Product Name: SEALING CAP FOR 10/12MM TROCARS Model/Catalog Number: EK085P Software Version: N/A Product Description: SEALING CAP FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
Brand Name: AESCULAP Product Name: SEALING UNIT FOR 10/12MM TROCARS Model/Catalog Number: EK086P Software Version: N/A Product Description: SEALING UNIT FOR 10/12MM TROCARS Component: N/A — Reason: It was determined there is the potential of silicone fragments detaching from the yellow sealing component. — Status: Ongoing
HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY — Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation. — Status: Ongoing
HL grant. $606,057. PI: Mercedes Aurelia Bravo
HL grant. $1,380,474. PI: Andrew John Admon
CA grant. $3,355,681. PI: Philip Chow
MH grant. $853,969. PI: Jazmin Brown-Iannuzzi
NS grant. $49,538. PI: Margaret Mary Cassidy
CA grant. $2,691,173. PI: Igor Landry Bado
HL grant. $184,464. PI: Kevin Owen Murray
AI grant. $122,103. PI: Najib M El-Sayed
MH grant. $359,433. PI: John F Neumaier
AI grant. $286,793. PI: Bernard Khor
AI grant. $182,208. PI: Brian T Fisher
AI grant. $300,435. PI: Carla Devillers
MH grant. $499,781. PI: Cameron Good
AI grant. $306,321. PI: Nuria Puigmal
AI grant. $993,353. PI: Ellen Monson
AI grant. $586,619. PI: JAMES A. LEDERER
AI grant. $248,538. PI: CHLOE L THIO
HL grant. $49,738. PI: Kevin-Phu C Le
AI grant. $3,411,692. PI: Susanna Naggie
HD grant. $25,596. PI: Ashura Mussa Bakari
CA grant. $998,781. PI: Sandeep Kakade