calendar
9,521 catalysts · 3,350 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings
next 91 dayslessmore
MonWedFri
9,521 catalysts · 3,350 8k filing · 2,032 grant · 1,000 device adverse event · 910 approval · 674 device 510k · 584 earnings
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: MVK. Advisory committee: CV. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 135 Review Track For 30-Day Notice. Product code: MTA. Advisory committee: OP. Decision: APPR
Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR
Supplement type: 30-Day Notice. Product code: DSQ. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Supplement type: 30-Day Notice. Product code: LPM. Advisory committee: OP. Decision: OK30
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications. — Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k). — Status: Ongoing
CA grant. $10,000. PI: Ken Chen
AR grant. $556,651. PI: Matthew K Abramowitz
DK grant. $1,934,914. PI: Ashley Nicole Battarbee
NS grant. $419,920. PI: SARA J ATON
Sponsor: TEVA. Form: TABLET. Route: ORAL
Sponsor: MICRO LABS. Form: POWDER. Route: ORAL
Sponsor: RUBICON RESEARCH. Form: SUSPENSION. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION
Sponsor: ANTHEA PHARMA. Form: POWDER. Route: INTRAMUSCULAR
Sponsor: MYLAN. Form: EMULSION. Route: INTRAVENOUS
Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL
Sponsor: TP ANDA HOLDINGS. Form: TABLET. Route: ORAL
Sponsor: CHATTEM SANOFI. Form: SOLUTION. Route: ORAL
Sponsor: PRAGMA. Form: FOR SUSPENSION. Route: ORAL
Sponsor: PRINSTON INC. Form: TABLET. Route: ORAL
Sponsor: JANSSEN BIOTECH. Form: TABLET. Route: ORAL
Sponsor: ANNORA PHARMA. Form: SUSPENSION. Route: ORAL
Product code: DXT. Advisory committee: Cardiovascular. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: SEW. Advisory committee: General Hospital. Type: Traditional
Product code: QPF. Advisory committee: Neurology. Type: Traditional
Product code: KLE. Advisory committee: Dental. Type: Traditional
Product code: HSB. Advisory committee: Orthopedic. Type: Traditional
Product code: JAK. Advisory committee: Radiology. Type: Traditional
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DXN. Advisory committee: Cardiovascular. Type: Traditional
Product code: LNH. Advisory committee: Radiology. Type: Traditional
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: QMG. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: MCX. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30
Supplement type: Real-Time Process. Product code: POH. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: MRM. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30
Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30
Supplement type: 30-Day Notice. Product code: MKJ. Advisory committee: CV. Decision: OK30
COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665. — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing
COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108 — Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. — Status: Ongoing