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calendar

34 catalysts · 31 device 510k · 3 approval

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Week of Jan 13, 2025

34
›Jan 17, 2025approval577d ago
SPRAVATO (ESKETAMINE HYDROCHLORIDE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: SPRAY. Route: NASAL

full page →fda approvals ↗
›Jan 17, 2025approval577d agoELELYSO (TALIGLUCERASE ALFA) — FDA approvaltaliglucerase alfa

Sponsor: PFIZER. Form: POWDER. Route: INTRAVENOUS

full page →taliglucerase alfa →fda approvals ↗
›Jan 17, 2025approval577d agoPEPCID COMPLETE (CALCIUM CARBONATE) — FDA approvalKenvue Inc.

Sponsor: KENVUE BRANDS. Form: TABLET, CHEWABLE. Route: ORAL

full page →fda approvals ↗
›Jan 17, 2025device 510k577d agoMED-EL Elektromedizinische Geräte GmbH — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (510k cleared)

Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoAirgas Therapeutics, LLC — ULSPIRA TS™ Nitric Oxide Therapy System (510k cleared)AUG Therapeutics LLC

Product code: MRN. Advisory committee: Anesthesiology. Type: Special

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoEthicon Endo-Surgery, LLC (A Johnson and Johnson Company) — The ETHICON™ Total Energy System (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMedos International SARL — TriALTIS™ Spine System (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoSHENZHEN SUPERLINE TECHNOLOGY CO., LTD. — Electronic Apex Locator (Alpha Apex I) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

Product code: LQY. Advisory committee: Unknown. Type: Traditional

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoVarian Medical Systems, Inc. — Embozene Color-Advanced Microspheres (510k cleared)MERIT MEDICAL SYSTEMS INC

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMedimaps Group SA — TBS iNsight (V4) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoPrenuvo — Prenuvo Body Composition (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoOlympus Medical Systems Corporation — EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMED-EL Elektromedizinische Geräte GmbH — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (510k cleared)

Product code: ETB. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoRoche Molecular Systems, Inc. — cobas® liat CT/NG nucleic acid test (510k cleared)

Product code: QEP. Advisory committee: Microbiology. Type: Dual Track

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMilvue — TechCare Trauma (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMedtronic, Inc. — Affera Integrated Mapping System (510k cleared)Medtronic plc

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoSofradim Production — ProGrip™ Self-Gripping Polypropylene Mesh (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoDraeger Medical Systems, Inc. — Babyroo TN300 (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: FMT. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoSonoscape Medical Corp. — Digital Color Doppler Ultrasound System (P60 Series) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoKoh Young Technology, Inc. — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

Product code: PAB. Advisory committee: Microbiology. Type: Special

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoPhilips Medizin Systeme Böblingen GmbH — Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoAmb Medtec — hygh-tec Drainage II (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMedtronic, Inc. — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) (510k cleared)Medtronic plc

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoAccess Vascular, Inc. — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMED-EL Elektromedizinische Geräte GmbH — mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (510k cleared)

Product code: ETA. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoWilson-Cook Medical, Inc. — Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (510k cleared)

Product code: KNS. Advisory committee: Gastroenterology, Urology. Type: Special

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMedtronic Sofamor Danek, Inc. — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoSmart Denture Conversions, LLC — Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) (510k cleared)

Product code: NHA. Advisory committee: Dental. Type: Abbreviated

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoGe Medical Systems Israel, Functional Imaging — Aurora (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoNeoventa Medical AB — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoMyocene — Myocene (510k cleared)

Product code: SDX. Advisory committee: Neurology. Type: Direct

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

full page →fda device 510k ↗
›Jan 17, 2025device 510k577d agoTrue Indicating, LLC — Type 5 Integrating Indicator for Steam (CSPN-15) (510k cleared)

Product code: JOJ. Advisory committee: General Hospital. Type: Traditional

full page →fda device 510k ↗
$PFE26.79-0.04%
$FRTRY
$MMSI90.76+0.29%
$KVUE19.200.00%
$MDT91.27+0.76%
$MMSI90.76+0.29%
$MDT91.27+0.76%