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33 catalysts · 18 approval · 5 device 510k · 5 device recall · 3 grant · 2 device pma
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33 catalysts · 18 approval · 5 device 510k · 5 device recall · 3 grant · 2 device pma
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL
Sponsor: HUMANWELL. Form: TABLET. Route: ORAL
Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS
Sponsor: TORRENT. Form: TABLET. Route: ORAL
Sponsor: JAZZ PHARMS THERAP. Form: POWDER. Route: INTRAVENOUS
Sponsor: EUGIA PHARMA. Form: INJECTABLE. Route: INTRAVENOUS
Sponsor: NATCO. Form: TABLET. Route: ORAL
Sponsor: MANKIND PHARMA. Form: TABLET. Route: ORAL
Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL
Sponsor: GLAUKOS. Form: IMPLANT. Route: INTRACAMERAL
Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL
Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL
Sponsor: GENZYME CORP. Form: TABLET. Route: ORAL
Sponsor: SANOFI AVENTIS US. Form: TABLET. Route: ORAL
Sponsor: SANDOZ. Form: INJECTABLE. Route: INJECTION
Sponsor: SUN PHARM INDS INC. Form: SUSPENSION. Route: ORAL
Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Special
Product code: HCG. Advisory committee: Neurology. Type: Special
Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional
Product code: LOL. Advisory committee: Microbiology. Type: Traditional
Product code: QAS. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: NWX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MIH. Advisory committee: CV. Decision: OK30
Impella RP Flex with SmartAssist. Product Code: 1000323. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing
Impella RP with SmartAssist. Product Code: 0046-0035. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing
Impella RP. Product Code: 0046-0011. — Reason: Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. — Status: Ongoing
10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bulk non-sterile units per case. — Reason: During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. — Status: Ongoing
CLARITY II Laser System; Model No. 1110200210. — Reason: Reports of devices sparking/popping and potentially burning patients. — Status: Ongoing
AI grant. $43,914. PI: Adrianna M. Rivera-León
NS grant. $625,859. PI: Rujuta Bhatt Wilson
AI grant. $780,787. PI: Gregoire Stephane Lauvau