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calendar

17,477 catalysts · 15,970 approval · 1,296 device 510k · 211 recall

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  • approval15,970
  • device 510k1,296
  • recall211
therapy area

no tagged catalysts yet

Week of Oct 21, 2024

38
›Oct 24, 2024approval
681d ago
JUBBONTI (DENOSUMAB-BBDZ) — FDA approvalJUBBONTI

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →JUBBONTI →fda approvals ↗
›Oct 24, 2024approval681d agoHEPARIN SODIUM — FDA approvalHEPARIN SODIUM

Sponsor: PFIZER. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
›Oct 24, 2024device 510k681d agoTelefield Medical Imaging (Shenzhen) Limited — Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoMedtronic Neurosurgery — Duet External Drainage and Monitoring System (EDMS) (510k cleared)

Product code: PCB. Advisory committee: Neurology. Type: Special

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoGt Metabolic Solutions, Inc. — MagDI System (MAG-01, DS-01) (510k cleared)Seed Health Inc

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoMedency S.R.L. — Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoDentsply Sirona — CEREC Cercon 4D CAD/CAM Blocks (510k cleared)DENTSPLY SIRONA Inc.

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoImplantcast GmbH — MUTARS® femoral stem cemented 160 mm and 200 mm (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoArgen Corporation — ArgenZ MTZ (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoKeystone Industries — KeyPrint KeyDenture Base (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoShenzhen Urion Technology Co., Ltd. — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoFoshan Shunkangda Medical Tech Co., Ltd. — Manual Wheelchair (SYIV100-CA9221) (510k cleared)

Product code: IOR. Advisory committee: Physical Medicine. Type: Traditional

full page →fda device 510k ↗
›Oct 24, 2024device 510k681d agoPhilips Medical Systems Nederland B.V. — ROCC Console (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024approval680d agoNOXAFIL POWDERMIX KIT (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval680d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval680d agoNOXAFIL (POSACONAZOLE) — FDA approvali3 Pharmaceuticals LLC

Sponsor: SCHERING. Form: SUSPENSION. Route: ORAL

full page →fda approvals ↗
›Oct 25, 2024approval680d agoNOXAFIL (POSACONAZOLE) — FDA approvalPOSACONAZOLE

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

full page →POSACONAZOLE →fda approvals ↗
›Oct 25, 2024approval680d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

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

full page →fda approvals ↗
›Oct 25, 2024device 510k680d agoSimBioSys, Inc. — TumorSight Viz (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k680d 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 510k680d 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 510k680d agoNorlase Aps — LYNX Photocoagulator (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d agoBiotronik, Inc. — Pantera Pro; Pantera LEO (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k680d 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 510k680d 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 510k680d agoCepheid® — Xpert® SA Nasal Complete (510k cleared)

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

full page →fda device 510k ↗
›Oct 25, 2024device 510k680d 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 ↗

Week of Oct 28, 2024

12
›Oct 28, 2024approval677d agoPOTASSIUM CHLORIDE — FDA approvalTWi Pharmaceuticals Inc

Sponsor: TWI PHARMS. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Oct 28, 2024device 510k677d agoMedtronic Sofamor Danek USA, Inc. — Catalyft™ LS Expandable Interbody System (510k cleared)Medtronic USA Inc

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoEthicon Endo-Surgery, LLC — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T) (510k cleared)

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoNingbo Caremed Medical Products Co., Ltd. — Sterile Lancets for Single Use (510k cleared)

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoCuriteva, Inc. — Curiteva Porous PEEK Laminoplasty System (510k cleared)

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoSpinal Alignment Solutions, Inc. — Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (510k cleared)

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoShenzhen Aozemei Technology Co., Ltd. — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (510k cleared)Fortior Technology (Shenzhen) Co., Ltd./ADR

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

full page →fda device 510k ↗
›Oct 28, 2024device 510k677d agoJellox Biotech, Inc. — MetaLite DX Digital Pathology Software (510k cleared)IO Biotech, Inc.

Product code: QKQ. Advisory committee: Pathology. Type: Traditional

full page →fda device 510k ↗
›Oct 29, 2024approval676d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗
›Oct 29, 2024approval676d agoSCEMBLIX (ASCIMINIB HYDROCHLORIDE) — FDA approvalasciminib hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →asciminib hydrochloride →fda approvals ↗
›Oct 29, 2024approval676d agoTICAGRELOR — FDA approvalAstraZeneca Pharmaceuticals LP

Sponsor: DR REDDYS. Form: TABLET. Route: ORAL

full page →fda approvals ↗
›Oct 29, 2024device 510k676d agoMicro Therapeutics, Inc. d/b/a ev3 Neurovascular — Riptide Aspiration System (510k cleared)

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

full page →fda device 510k ↗
← prev
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$FRTRY
$MRK152.34+0.46%
$PFE28.81-0.72%
$AVNS
$DDD
$FRTRY
$DFUKF
$DDD
$XRAY11.43+1.24%
$FRTRY
$IOBTQ
$NVS163.09+0.39%
$NVS163.09+0.39%