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calendar

25 catalysts · 20 device 510k · 5 approval

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  • device 510k20
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no tagged catalysts yet

Week of Oct 21, 2024

25
›Oct 25, 2024approval676d ago
NOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MSD MERCK CO. Form: FOR SUSPENSION, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval676d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: SOLUTION. Route: INTRAVENOUS

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval676d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Oct 25, 2024approval676d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

Sponsor: MERCK SHARP DOHME. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval676d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

Sponsor: ITERUM THERAP. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 25, 2024device 510k676d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

Product code: QIH. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoShenzhen Beacon Display Technology Co., Ltd. — LCD Monitors C310S, G310S, C316S, G316S, C616W (510k cleared)

Product code: PGY. Advisory committee: Radiology. Type: Special

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoShenzhen Yimi Life Technology Co., Ltd. — Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoAvanos Medical, Inc. — CORGRIP* SR NG/NI Tube Retention System (510k cleared)AVANOS MEDICAL, INC.

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoMetko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi — FMT Disposable and Autoclavable Temperature Probes (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoNeurophet., Inc. — Neurophet AQUA (V3.1) (510k cleared)NeurOp Inc

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoOrtho Development Corp. — BKS Revision System (510k cleared)DeFi Development Corp.

Product code: JWH. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoCryoconcepts LP — Freeze Point & Private Label Versions (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d ago3D Systems, Inc. — Cadence Ankle PSI System (510k cleared)3D SYSTEMS CORP

Product code: OYK. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoOcuject, LLC — LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoDistalmotion SA — Dexter L6 System (510k cleared)

Product code: SDD. Advisory committee: General, Plastic Surgery. Type: Direct

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoBruno Vision Care, LLC — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoUlike Co., Ltd. — Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d ago3D Systems, Inc. — Salto Talaris Ankle PSI System (510k cleared)3D SYSTEMS CORP

Product code: OYK. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoQIAGEN GmbH — QIAstat-Dx Respiratory Panel Mini (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoVATECH Co., Ltd. — VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k676d agoComfort Rubber Gloves Industries Sdn. Bhd. — Nitrile Powder Free Examination Gloves Biodegradable (Green) (510k cleared)

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

full page →fda device 510k ↗
$MRK148.35-0.80%
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