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calendar

25 catalysts · 21 device 510k · 4 approval

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no tagged catalysts yet

Week of Nov 11, 2024

25
›Nov 15, 2024approval655d ago
STELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Nov 15, 2024approval655d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab →fda approvals ↗
›Nov 15, 2024approval655d agoEPYSQLI (ECULIZUMAB-AAGH) — FDA approvalEPYSQLI

Sponsor: SAMSUNG BIOEPIS CO LTD. Form: INJECTION. Route: SOLUTION

full page →EPYSQLI →fda approvals ↗
›Nov 15, 2024approval655d agoREVUFORJ (REVUMENIB CITRATE) — FDA approvalrevumenib citrate

Sponsor: SYNDAX. Form: TABLET. Route: ORAL

full page →revumenib citrate →fda approvals ↗
›Nov 15, 2024device 510k655d agoBoston Scientific Corporation — AdVance™ XP Male Sling System (720163-03) (510k cleared)BOSTON SCIENTIFIC CORP

Product code: OTM. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoHologic, Inc. — Panther Fusion SARS-CoV-2/Flu A/B/RSV assay (510k cleared)

Product code: QOF. Advisory committee: Microbiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoDent4you AG — Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (510k cleared)

Product code: ELW. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoCarlsmed, Inc. — aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM (510k cleared)CARLSMED, INC.

Product code: ODP. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoVuno, Inc. — VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage (510k cleared)

Product code: QFM. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoKoios Medical, Inc. — Koios DS (510k cleared)

Product code: POK. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoVascutek, Ltd. — Gelsoft™ Plus Vascular Prostheses (510k cleared)

Product code: DSY. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoTianjin Huahong Technology Co., Ltd. — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T) (510k cleared)

Product code: QRL. Advisory committee: General, Plastic Surgery. Type: Special

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoMycardium AI Limited — 1CMR Pro (510k cleared)

Product code: LLZ. Advisory committee: Radiology. Type: Abbreviated

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoCreagh Medical Ltd. Dba Surmodics, Inc. — 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter (510k cleared)

Product code: LIT. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoUltromics Limited — EchoGo Amyloidosis (1.0) (510k cleared)

Product code: SDJ. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoPhilips Ultrasound, LLC — The 5000 Compact Series Ultrasound Systems (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoVieworks Co., Ltd. — VIVIX-S 1751S (510k cleared)

Product code: MQB. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoBlue Belt Technologies, Inc. — CORIOGRAPH Pre-Op Planning and Modeling Services (510k cleared)BETA Technologies, Inc.

Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoShenzhen Vitavitro Biotech Co., Ltd. — VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) (510k cleared)Shenzhen MagicRNA Biotech Co Ltd

Product code: MQE. Advisory committee: Obstetrics/Gynecology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoInfinitum Eta, Ltd. — NUVENTUS NV.C™ Dental Implant System (510k cleared)

Product code: DZE. Advisory committee: Dental. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoB-One Ortho, Corp. — b-ONE® Total Hip System (510k cleared)

Product code: LZO. Advisory committee: Orthopedic. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoTHINK Surgical, Inc. — TMINI Miniature Robotic System (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoSurgical Instrument Service and Savings Inc.(Dba Medline Ren — Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) (510k cleared)

Product code: NLH. Advisory committee: Cardiovascular. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoSiemens Medical Solutions USA, Inc. — ACUSON Redwood Diagnostic Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

full page →fda device 510k ↗
›Nov 15, 2024device 510k655d agoLivsmed, Inc. — ArtiSeal Vessel Sealing System-ArtiSeal Instruments; ArtiSeal Vessel Sealing System-ArtiSeal Generator (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

full page →fda device 510k ↗
$JNJ268.04+0.85%
$BETA16.10+2.09%
$CARL
$SNDX19.54-3.08%
$BSX46.84+0.36%