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calendar

23 catalysts · 18 device 510k · 5 approval

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  • device 510k18
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no tagged catalysts yet

Week of Dec 16, 2024

23
›Dec 17, 2024approval622d ago
GABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: ALKEM LABS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Dec 17, 2024approval622d agoVIGABATRIN — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: AMNEAL PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Dec 17, 2024approval622d agoVIGABATRIN — FDA approvalTeva Pharmaceuticals USA Inc

Sponsor: TEVA PHARMS USA. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Dec 17, 2024approval622d agoSTEQEYMA (USTEKINUMAB-STBA) — FDA approvalSTEQEYMA

Sponsor: CELLTRION, INC.. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →STEQEYMA →fda approvals ↗
›Dec 17, 2024approval622d agoBLINCYTO (BLINATUMOMAB) — FDA approvalblinatumomab

Sponsor: AMGEN. Form: INJECTABLE. Route: INJECTION

full page →blinatumomab →fda approvals ↗
›Dec 17, 2024device 510k622d agoVizionfocus, Inc. — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens (510k cleared)

Product code: LPL. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoAsahi Intecc Co., Ltd. — Tornus ES (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoBisco, Inc. — Quantium (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoO&M Halyard, Inc. — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

Product code: LZA. Advisory committee: General Hospital. Type: Abbreviated

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoPhilips Medizin Systeme Böblingen GmbH — Cardiac Workstation (5000); Cardiac Workstation (7000) (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoPrecision Spine, Inc. — Reform Pedicle Screw System (510k cleared)Precision Dose Inc

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoHealgen Scientific,, LLC — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup (510k cleared)

Product code: NGL. Advisory committee: Clinical Toxicology. Type: Traditional

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoHivox Biotek, Inc. — POCKET TENS (EP-300) (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoAi Optics — Sentinel Camera (510k cleared)

Product code: HKI. Advisory committee: Ophthalmic. Type: Traditional

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoInova Diagnostics, Inc. — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (510k cleared)Co-Diagnostics, Inc.

Product code: MID. Advisory committee: Immunology. Type: Traditional

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoJiangmen New Era External Use Drug Co., Ltd. — Autoclave Indicator Tape; EO Indicator Tape (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoSmith & Nephew Medical Limited — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoVentana Medical Systems, Inc. — Roche Digital Pathology Dx (510k cleared)MERIT MEDICAL SYSTEMS INC

Product code: PSY. Advisory committee: Pathology. Type: Special

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoDentsply Sirona, Inc. — Lucitone Digital Print Denture™ System (510k cleared)DENTSPLY SIRONA Inc.

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoAllengers Global Healthcare Private Limited — Thulium Fiber Laser (FiberLAZE+, FiberLAZE) (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoCntrl+, Inc. — Cntrl+ Bladder Support Pessary (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoAllonus Tech Co., Ltd. — ALLONUS Tech Prosthetics (510k cleared)

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

full page →fda device 510k ↗
›Dec 17, 2024device 510k622d agoCentinel Spine, LLC — prodisc® L Instruments (510k cleared)

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

full page →fda device 510k ↗
$XRAY11.12+0.72%
$SNN28.97-0.55%
$AMRX17.54-2.61%
$CODX1.51000.00%
$MMSI90.49+1.06%
$AMGN432.42-1.05%