Calendar

pharmadog

Week of Jan 13, 2025

Jan 17, 2025device 510k572d agoMilvue — TechCare Trauma (510k cleared)

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

full page →fda device 510k ↗

Jan 17, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d agoHologic, Inc. — Aptima CMV Quant Assay (510k cleared)

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

full page →fda device 510k ↗

Jan 17, 2025device 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d 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 510k572d agoMyocene — Myocene (510k cleared)

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

full page →fda device 510k ↗

Jan 17, 2025device 510k572d agoUnity Medical, Inc. — VersaD Delivery Catheter (510k cleared)

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

full page →fda device 510k ↗

Jan 17, 2025device 510k572d 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 ↗

Jan 19, 2025device 510k570d agoNavi Medical Technologies — Neonav ECG Tip Location System (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗

Week of Jan 20, 2025

Jan 21, 2025approval568d agoPOTELIGEO (MOGAMULIZUMAB-KPKC) — FDA approvalmogamulizumab

Sponsor: KYOWA KIRIN. Form: INJECTABLE. Route: INJECTION

full page →mogamulizumab →fda approvals ↗

Jan 21, 2025approval

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