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calendar

19 catalysts · 16 device 510k · 3 approval

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  • device 510k16
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no tagged catalysts yet

Week of Nov 4, 2024

19
›Nov 7, 2024approval663d ago
DANZITEN (NILOTINIB TARTRATE) — FDA approvalDANZITEN

Sponsor: AZURITY. Form: TABLET. Route: ORAL

full page →DANZITEN →fda approvals ↗
›Nov 7, 2024approval663d agoPIFELTRO (DORAVIRINE) — FDA approvaldoravirine

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →doravirine →fda approvals ↗
›Nov 7, 2024approval663d agoDELSTRIGO (DORAVIRINE) — FDA approval(doravirine + lamivudine + tenofovir disoproxil fumarate)

Sponsor: MSD MERCK CO. Form: TABLET. Route: ORAL

full page →(doravirine + lamivudine + tenofovir disoproxil fumarate) →fda approvals ↗
›Nov 7, 2024device 510k663d agoExostat Medical, Inc. — MicroTrend System (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoInrad, Inc. — Trilogy Tissue Marker (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoSpident Co., Ltd. — VioSeal (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoRebotix — Remanufactured EndoWrist ProGrasp Forceps (420093) (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoNeurocareai, Inc. — NeuroICH (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoVarian Medical Systems, Inc. — Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoStryker Spine — OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System; MESA® Spinal System; MESA® Small Stature Spinal System; CASPIAN® Spinal System; DENALI® Spinal System; DENALI® MI Spinal System; YUKON OCT Spinal System; Xia® 3 Spinal System; K2M Patient Specific; CASCADIA™ Interbody System; CAYMAN® Plate System; CAYMAN® Plate System-MI (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoAspen Imaging Healthcare, Inc. — IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoBiofire Diagnostics, LLC — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoZsfab — ZSFab Cervical Interbody System; ZSFab Lumbar Interbody System (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoOssvis Co., Ltd. — LL Implant System (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoShenzhen Greatro Electronic Technology Co., Ltd. — Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoFoundation Surgical Group, Inc. — Vertiwedge® Intraosseous System (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoMako Surgical Corp. — Mako Shoulder Application (1.0) (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoIcometrix NV — icobrain aria (510k cleared)

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

full page →fda device 510k ↗
›Nov 7, 2024device 510k663d agoNewclip Technics — Newclip Patient-matched instrumentation non sterile PSI (510k cleared)

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

full page →fda device 510k ↗
$MRK148.35-0.80%
$MRK148.35-0.80%
$MMSI90.49+1.06%