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calendar

25,822 catalysts · 16,936 approval · 3,617 device 510k · 2,351 grant · 1,087 device recall · 1,069 device pma · 762 recall

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  • approval16,936
  • device 510k3,617
  • grant2,351
  • device recall1,087
  • device pma1,069
  • recall762
therapy area

no tagged catalysts yet

Week of Oct 14, 2024

8
›Oct 18, 2024device 510k685d agoBoston 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 510k685d 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 510k685d 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 510k685d agoRestor3D — Kinos Total Ankle System (510k cleared)

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

full page →fda device 510k ↗
›Oct 18, 2024device 510k685d 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 510k685d 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 510k685d 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 510k685d 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, 2024approval682d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

full page →berotralstat hydrochloride →fda approvals ↗
›Oct 21, 2024device 510k682d 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 510k682d 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 510k682d 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 510k682d 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 510k682d 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 510k682d 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 510k682d 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 510k682d 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 510k681d 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 510k681d 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 510k681d 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 510k681d 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 510k681d 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 510k681d agoNordicneurolab AS — nordicMEDiVA (510k cleared)

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

full page →fda device 510k ↗
›Oct 22, 2024device 510k681d 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 510k681d 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 510k681d 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 510k681d 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, 2024approval680d agoBKEMV (ECULIZUMAB-AEEB) — FDA approvaleculizumab biosimilar

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

full page →eculizumab biosimilar →fda approvals ↗
›Oct 23, 2024approval680d agoVIGABATRIN — FDA approvalVIGABATRIN

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

full page →VIGABATRIN →fda approvals ↗
›Oct 23, 2024approval680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d agoVarian Medical Systems — Vitesse (5.0) (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d 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 510k680d agoSpineart SA — Scarlet® AL-T (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k680d 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 510k680d 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 510k680d 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 510k680d agoBiomet 3i, LLC — Immediate Molar Implants (510k cleared)

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

full page →fda device 510k ↗
›Oct 23, 2024device 510k680d 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 510k680d 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 510k680d 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, 2024approval679d agoFLONASE SENSIMIST ALLERGY RELIEF (FLUTICASONE FUROATE) — FDA approvalGlaxoSmithKline LLC

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

full page →fda approvals ↗
›Oct 24, 2024approval679d agoFLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) — FDA approvalParatek Pharmaceuticals Inc

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

full page →fda approvals ↗
›Oct 24, 2024approval679d 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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$BCRX10.17+2.52%
$BSX48.08-0.46%
$AMGN438.12+1.92%
$SNN28.970.00%
$AAPL298.01+0.70%
$TTMI
$MDCE0.00020.00%
$ASUR8.2700+1.35%