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calendar

17,927 catalysts · 16,099 approval · 1,565 device 510k · 263 recall

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  • approval16,099
  • device 510k1,565
  • recall263
therapy area

no tagged catalysts yet

Week of Oct 14, 2024

8
›Oct 18, 2024device 510k
687d ago
Boston Scientific Corp — IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (510k cleared)BOSTON SCIENTIFIC CORP

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoWellmed Dental Medical Supply Co., Ltd. — Dental Barrier and Sleeves (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoWell-Life Healthcare Limited — Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoMvision AI OY — Contour+ (MVision AI Segmentation) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoColoplast Corp. — Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoXiantao Daoqi Plastic Co., Ltd. — Surgical Face Mask (Tie on/ Ear loops) (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k687d agoOystershell NV — Pixie Skin Tag (510k cleared)

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

full page →fda device 510k ↗

Week of Oct 21, 2024

42
›Oct 21, 2024approval684d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

full page →berotralstat hydrochloride →fda approvals ↗
›Oct 21, 2024device 510k684d agoStryker Instruments — PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (510k cleared)

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoiRhythm Technologies, Inc. — Zio AT® device (A100A1001) (510k cleared)TTM TECHNOLOGIES INC

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoApple, Inc. — Digital Prism Correction Feature (DPCF) (510k cleared)Apple Inc.

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoMomentis Surgical , Ltd. — Anovo Surgical System (Model 6Ne) (510k cleared)

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoTalladium España, SL — Dynamic TiBase; TRI Screws (510k cleared)

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoArthrex, Inc. — Arthrex VAL and VAL KreuLock™ Compression Screw System (510k cleared)

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoSmith & Nephew, Inc. — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗
›Oct 21, 2024device 510k684d agoSpeciality Fibres and Materials, Ltd. — Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoBrosmed Medical Co., Ltd. — Tri-Wedge PTA Scoring Balloon Dilatation Catheter (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoSiemens Medical Solutions USA, Inc. — ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoSol-Millennium Medical, Inc. — Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoAvita Corporation — Arm Type Blood Pressure Monitor (BPM82) (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d ago3-D Matrix Europe SAS — PuraStat (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoNordicneurolab AS — nordicMEDiVA (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoStryker Sustainability Solutions — Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoShanghai SeeGen Photoelectric Technology Co., Ltd. — Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoKarl Storz Endoscopy America, Inc. — KARL STORZ Holders (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k683d agoTianjin Mastervision Technology Co., Ltd. — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024approval682d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

Sponsor: AMGEN INC. Form: INJECTABLE. Route: INJECTION

full page →eculizumab biosimilar →fda approvals ↗
›Oct 23, 2024approval682d agoVIGABATRIN — FDA approvalVIGABATRIN

Sponsor: ACCORD HLTHCARE. Form: FOR SOLUTION. Route: ORAL

full page →VIGABATRIN →fda approvals ↗
›Oct 23, 2024approval682d agoBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE (ASPIRIN) — FDA approvalBUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE

Sponsor: NOVITIUM PHARMA. Form: CAPSULE. Route: ORAL

full page →BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE →fda approvals ↗
›Oct 23, 2024device 510k682d agoL&K BIOMED Co., Ltd. — BluEX Lumbar Expandable Cage System (510k cleared)NeuCen BioMed Co Ltd

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoMim Software, Inc. — MIM – Symphony HDR Fusion (510k cleared)ASURE SOFTWARE INC

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoEpic Medical Pte. , Ltd. — ProSeal™ Closed System Bag Access (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoGuangdong Optomedic Technologies, Inc. — FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoMedtronic Sofamor Danek USA, Inc. — CD Horizon™ Spinal System (510k cleared)Medtronic USA Inc

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoAdaptiiv Medical Technologies, Inc. — TrueFit Bolus; TrueFlex Bolus (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoDRTECH Corporation — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoAffinity Biosensors, LLC — LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoThe Orthopaedic Implant Company — OIC Small / Mini Fragment Plate System (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoScivita Medical Technology Co., Ltd. — Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (510k cleared)NewBay Medical Technology Co Ltd

Product code: EOQ. Advisory committee: Ear, Nose, Throat. Type: Traditional

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoParagonix Technologies — KIDNEYvault Portable Renal Perfusion System (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoWeifang Mingliang Electronics Co., Ltd. — Fractional CO2 Laser Therapy System (EXFU CO2) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoImmunodiagnostic Systems Limited — IDS-iSYS Free Testosterone (510k cleared)Transdermal Delivery Solutions Corp

Product code: CDZ. Advisory committee: Clinical Chemistry. Type: Traditional

full page →fda device 510k ↗
›Oct 23, 2024device 510k682d agoTsk Laboratory International Japan KK — STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (510k cleared)

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

full page →fda device 510k ↗
›Oct 24, 2024approval681d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Oct 24, 2024approval681d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

Sponsor: HALEON US HOLDINGS. Form: SPRAY, METERED. Route: NASAL

full page →fda approvals ↗
›Oct 24, 2024approval681d agoHEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (HEPARIN SODIUM) — FDA approvalHEPARIN SODIUM

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →HEPARIN SODIUM →fda approvals ↗
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$BCRX10.09-0.79%
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