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calendar

12 catalysts · 9 device 510k · 3 approval

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no tagged catalysts yet

Week of May 19, 2025

12
›May 20, 2025approval468d ago
AMJEVITA (ADALIMUMAB-ATTO) — FDA approvalAMJEVITA

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →AMJEVITA →fda approvals ↗
›May 20, 2025approval468d agoCYLTEZO (ADALIMUMAB-ADBM) — FDA approvalCYLTEZO

Sponsor: BOEHRINGER INGELHEIM. Form: INJECTABLE. Route: INJECTION

full page →CYLTEZO →fda approvals ↗
›May 20, 2025approval468d agoHYRIMOZ (ADALIMUMAB-ADAZ) — FDA approvalHYRIMOZ

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

full page →HYRIMOZ →fda approvals ↗
›May 20, 2025device 510k468d agoFlexicare Medical Limited. — ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (510k cleared)

Product code: BTR. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoAidite (Qinhuangdao) Technology Co., Ltd. — Biomic Color Opaque (510k cleared)

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

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoBreas Medical AB — EveryWare (510k cleared)

Product code: MOD. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoExpanding Innovations, Inc. — X-PAC® N-GAGE™ Lumbar Plate System (510k cleared)

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

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoABBOTT MEDICAL — ViewFlex™ X ICE Catheter, Sensor Enabled™ (510k cleared)

Product code: OBJ. Advisory committee: Cardiovascular. Type: Special

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoFujifilm Corporation — SCENARIA View Phase 5.0 (510k cleared)Fujifilm Holdings Corp

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

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoMet One Technologies, LLC — Sovereign Posterior Cervical System (510k cleared)

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

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoMedtronic, Inc. — VitalFlow Console (510k cleared)Medtronic plc

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

full page →fda device 510k ↗
›May 20, 2025device 510k468d agoKeystone Industries — FP3D (510k cleared)

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

full page →fda device 510k ↗
$AMGN432.42-1.05%
$MDT91.23+1.40%