Calendar

Week of Apr 14, 2025

Apr 14, 2025device 510k485d agoNeuralynx, Inc. — Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) (510k cleared)Neuraly Inc

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

full page →fda device 510k ↗

Apr 14, 2025device 510k485d agoMerge Healthcare Incorporated — Merge Universal Viewer (MUV) (510k cleared)

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

full page →fda device 510k ↗

Apr 14, 2025device 510k485d agoAVAVA, Inc. — AVAVA Skin Treatment System (510k cleared)

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

full page →fda device 510k ↗

Apr 14, 2025device 510k485d agoAdvanced Sterilization Products, Inc. — STERRAD® 100NX Sterilizer with ALLClear Technology (10104) (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025approval484d agoISTURISA (OSILODROSTAT PHOSPHATE) — FDA approvalosilodrostat phosphate

Sponsor: RECORDATI RARE. Form: TABLET. Route: ORAL

full page →osilodrostat phosphate →fda approvals ↗

Apr 15, 2025approval484d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: SUNSHINE. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Apr 15, 2025device 510k484d agoEMA Aesthetics , Ltd. — Préime DermaFacial Collagen+ (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoCryoconcepts LP — Skin Clinic Nitro Clear Wart Remover (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoThermo Fisher Scientific — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (510k cleared)THERMO FISHER SCIENTIFIC INC.

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoArineta , Ltd. — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoSight Sciences, Inc. — TearCare MGX System (510k cleared)Sight Sciences, Inc.

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoBoston Scientific Corporation — Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (510k cleared)BOSTON SCIENTIFIC CORP

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoAnhui Deepblue Medical Technological Co., Ltd. — Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoGeistlich Pharma AG — SwissMembrane X; SwissMembrane X Socket (510k cleared)

Product code: NPL. Advisory committee: Dental. Type: Special

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoArk Surgical — LapBox Power Tissue Containment System (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoStryker Instruments — OptaBlate Radiofrequency (RF) Generator System (510k cleared)

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

full page →fda device 510k ↗

Apr 15, 2025device 510k484d agoSteris — Electro Lube NXT (510k cleared)STERIS plc

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

full page →fda device 510k ↗

Apr 16, 2025approval483d agoDUPIXENT (DUPILUMAB) — FDA approvaldupilumab

Sponsor: REGENERON PHARMACEUTICALS. Form: INJECTABLE. Route: INJECTION

full page →dupilumab →fda approvals ↗

Apr 16, 2025approval483d agoCARBAMAZEPINE — FDA approvalcarbamazepine ER

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →carbamazepine ER →fda approvals ↗

Apr 16, 2025recall483d agoSomerset Therapeutics Private Limited recall (Cls II)Somerset Therapeutics LLC

Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePoint Laboratories NDC 68001-580-41 — Reason: Lack of Assurance of Sterility: Media fill with bacterial contamination — Status: Ongoing

Week of Apr 14, 2025