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10,001 catalysts · 3,126 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
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10,001 catalysts · 3,126 8k filing · 2,091 grant · 1,128 approval · 1,000 device adverse event · 848 device 510k · 610 device pma
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: ODP. Advisory committee: Orthopedic. Type: Traditional
Product code: BTT. Advisory committee: Anesthesiology. Type: Traditional
Product code: DJG. Advisory committee: Clinical Toxicology. Type: Traditional
Product code: NHB. Advisory committee: Ear, Nose, Throat. Type: Traditional
Product code: OWB. Advisory committee: Radiology. Type: Special
Product code: QIH. Advisory committee: Radiology. Type: Traditional
Product code: DHB. Advisory committee: Immunology. Type: Traditional
Product code: NAY. Advisory committee: Gastroenterology, Urology. Type: Traditional
Product code: MRW. Advisory committee: Unknown. Type: Traditional
Product code: GKZ. Advisory committee: Hematology. Type: Traditional
Product code: NGX. Advisory committee: Physical Medicine. Type: Traditional
Product code: GZJ. Advisory committee: Neurology. Type: Traditional
Product code: MWI. Advisory committee: Cardiovascular. Type: Traditional
Product code: LCJ. Advisory committee: Unknown. Type: Special
Product code: DXO. Advisory committee: Cardiovascular. Type: Traditional
Supplement type: Normal 180 Day Track No User Fee. Product code: SFJ. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: NPV. Advisory committee: CV. Decision: OK30
Supplement type: Normal 180 Day Track No User Fee. Product code: NQR. Advisory committee: NE. Decision: APPR
Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NRA. Advisory committee: OR. Decision: APPR
Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30
Supplement type: 30-Day Notice. Product code: LEI. Advisory committee: GU. Decision: OK30
Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR
Supplement type: 30-Day Notice. Product code: LEI. Advisory committee: GU. Decision: OK30
MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing with Active Leptospermum Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds. — Reason: Potential packaging failures, which could lead to a breach in the sterile barrier. — Status: Ongoing
Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions. — Reason: Potential packaging failures, which could lead to a breach in the sterile barrier. — Status: Ongoing
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. — Reason: Issue with software algorithm which may lead to overpressure events. — Status: Ongoing
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. — Reason: Issue with software algorithm which may lead to overpressure events. — Status: Ongoing
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological — Reason: Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed, — Status: Ongoing
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds — Reason: Potential packaging failures, which could lead to a breach in the sterile barrier. — Status: Ongoing
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. — Reason: Issue with software algorithm which may lead to overpressure events. — Status: Ongoing
DK grant. $686,129. PI: Markus Grompe
DE grant. $419,375. PI: Kelly Christine Rice
NS grant. $126,900. PI: Eddy Albarran
EY grant. $76,120. PI: Sofia Krasovskaya
AI grant. $33,538. PI: Alexandra Tabachnikova
DE grant. $78,840. PI: Hagar Kenawy
NS grant. $674,950. PI: ZHIGANG HE
DE grant. $435,875. PI: Santiago Orrego
HL grant. $49,538. PI: Vasundhara Singh
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: SUN PHARM INDS LTD. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL
Sponsor: WATSON LABS. Form: CAPSULE. Route: ORAL