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calendar

10 catalysts · 7 device 510k · 3 approval

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no tagged catalysts yet

Week of Mar 10, 2025

10
›Mar 11, 2025approval538d ago
TRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 11, 2025approval538d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 11, 2025approval538d agoTRELSTAR (TRIPTORELIN PAMOATE) — FDA approvaltriptorelin pamoate ER

Sponsor: VERITY. Form: INJECTABLE. Route: INTRAMUSCULAR

full page →triptorelin pamoate ER →fda approvals ↗
›Mar 11, 2025device 510k538d agoIconocare Health — 8mm Monopolar Curved Scissors (470179) (510k cleared)

Product code: QSM. Advisory committee: Gastroenterology, Urology. Type: Traditional

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoStryker Instruments — iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (510k cleared)

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

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoDeka Research & Development Corp. — RemunityPRO™ Pump for Remodulin® (treprostinil) Injection (510k cleared)UNITED THERAPEUTICS Corp

Product code: FRN. Advisory committee: General Hospital. Type: Special

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoArthrex, Inc. — Arthrex TightRope Soft Button, RT (510k cleared)

Product code: MBI. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoDisa Medinotec — OutFlo Aortic Valve Dilatation Balloon Catheter (510k cleared)

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

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoBetter Diagnostics AI Corp. — Better Diagnostics Caries Assist (BDCA) Version 1.0 (510k cleared)CS DIAGNOSTICS CORP.

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

full page →fda device 510k ↗
›Mar 11, 2025device 510k538d agoSignature Orthopaedics Pty, Ltd. — Origin™ TT Stem (510k cleared)

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

full page →fda device 510k ↗
$CSDX0.0634-32.91%
$UTHR515.46-2.36%