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calendar

28,263 catalysts · 17,815 approval · 4,115 device 510k · 2,475 grant · 1,585 device recall · 1,367 device pma · 906 recall

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  • approval17,815
  • device 510k4,115
  • grant2,475
  • device recall1,585
  • device pma1,367
  • recall906
therapy area

no tagged catalysts yet

Week of Mar 24, 2025

21
›Mar 28, 2025approval525d agoPLUVICTO (LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN) — FDA approvallutetium Lu 177 vipivotide tetraxetan

Sponsor: NOVARTIS. Form: SOLUTION. Route: INTRAVENOUS

full page →lutetium Lu 177 vipivotide tetraxetan →fda approvals ↗
›Mar 28, 2025approval525d agoABILIFY MAINTENA KIT (ARIPIPRAZOLE) — FDA approvalaripiprazole LA

Sponsor: OTSUKA PHARM CO LTD. Form: FOR SUSPENSION, EXTENDED RELEASE. Route: INTRAMUSCULAR

full page →aripiprazole LA →fda approvals ↗
›Mar 28, 2025approval525d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 28, 2025approval525d agoBRIXADI (BUPRENORPHINE) — FDA approvalbuprenorphine LA

Sponsor: BRAEBURN. Form: SOLUTION, EXTENDED RELEASE. Route: SUBCUTANEOUS

full page →buprenorphine LA →fda approvals ↗
›Mar 28, 2025approval525d agoACETAMINOPHEN AND CODEINE PHOSPHATE (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 28, 2025approval525d agoIMFINZI (DURVALUMAB) — FDA approvalASTRAZENECA PLC

Sponsor: ASTRAZENECA UK LTD. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Mar 28, 2025approval525d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Mar 28, 2025device 510k525d agoMedphoton GmbH — ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0) (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoSiemens Healthcare Diagnostic Products GmbH — INNOVANCE Antithrombin (510k cleared)

Product code: JBQ. Advisory committee: Hematology. Type: Traditional

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoWuxi Jiajian Medical Instrument Co., Ltd. — Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoBeckman Coulter, Inc. — Access Toxo IgG (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoConvatec — Flexi-Seal AIR (with ENFit Connector) (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoArthrex, Inc. — Arthrex FiberTak Suture Anchor (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoMakani Science, Inc. — Makani Science™ Respiration Monitoring System (510k cleared)

Product code: BZQ. Advisory committee: Anesthesiology. Type: Traditional

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoTuring Medical Technologies, Inc. — Bullsai Confirm (510k cleared)Medical Care Technologies Inc.

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoSmith & Nephew, Inc. — CATALYSTEM Femoral Stems (510k cleared)SMITH & NEPHEW PLC

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoSynthes GmbH — Synthes Graphic Case & Tray System (510k cleared)

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoSelux Diagnostics, Inc. — PBC Separator with Selux AST System (510k cleared)Co-Diagnostics, Inc.

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

full page →fda device 510k ↗
›Mar 28, 2025device 510k525d agoVisby Medical, Inc. — Visby Medical Women's Sexual Health Test (510k cleared)Vivani Medical, Inc.

Product code: SEA. Advisory committee: Microbiology. Type: Direct

full page →fda device 510k ↗
›Mar 30, 2025device 510k523d agoAlpha Omega Engineering , Ltd. — Neuro Omega System; NeuroSmart System (510k cleared)

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

full page →fda device 510k ↗
›Mar 30, 2025device 510k523d agoPrecision Neuroscience, Corp. — Layer 7-T (510k cleared)

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

full page →fda device 510k ↗

Week of Mar 31, 2025

29
›Mar 31, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: STRIDES PHARMA INTL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 31, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 31, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalPolyPid Ltd.

Sponsor: HIKMA INTL PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Mar 31, 2025approval522d agoDOXYCYCLINE HYCLATE — FDA approvalDOXYCYCLINE HYCLATE

Sponsor: MYLAN. Form: TABLET. Route: ORAL

full page →DOXYCYCLINE HYCLATE →fda approvals ↗
›Mar 31, 2025approval522d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗
›Mar 31, 2025approval522d agoPYLERA (BISMUTH SUBCITRATE POTASSIUM) — FDA approval

Sponsor: LABS JUVISE. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗
›Mar 31, 2025device 510k522d agoTribusmed Beheer BV — TribusConnect (510k cleared)

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

full page →fda device 510k ↗
›Mar 31, 2025device 510k522d agoShantou Institute of Ultrasonic Instruments Co., Ltd. — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppler Ultrasound Imaging System (Apogee C2); Digital Color Doppler Ultrasound Imaging System (Apogee C3); Digital Color Doppler Ultrasound Imaging System (Apogee C5); Digital Color Doppler Ultrasound Imaging System (Apogee K1); Digital Color Doppler Ultrasound Imaging System (Apogee K2); Digital Color Doppler Ultrasound Imaging System (Apogee K3); Digital Color Doppler Ultrasound Imaging System (Apogee K5); Di (510k cleared)

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

full page →fda device 510k ↗
›Mar 31, 2025device 510k522d agoTaewoong Medical Co., Ltd. — Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent (510k cleared)

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

full page →fda device 510k ↗
›Mar 31, 2025device 510k522d agoHangzhou SHINING3D Dental Technology Co., Ltd. — Denture Base Resin DT20 (510k cleared)

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

full page →fda device 510k ↗
›Mar 31, 2025device 510k522d agoOlympus Medical Systems Corp. — Disposable Grasping Forceps FG-52D/FG-54D (510k cleared)

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

full page →fda device 510k ↗
›Mar 31, 2025device 510k522d agoBridge TO Life — Belzer UW® Cold Storage Solution (BTLBUW-001) (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025approval521d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Apr 1, 2025approval521d agoSTELARA (USTEKINUMAB) — FDA approvalustekinumab

Sponsor: JANSSEN BIOTECH. Form: INJECTABLE. Route: INJECTION

full page →ustekinumab →fda approvals ↗
›Apr 1, 2025approval521d agoADZENYS XR-ODT (AMPHETAMINE) — FDA approvalTraws Pharma, Inc.

Sponsor: NEOS THERAPS. Form: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE. Route: ORAL

full page →fda approvals ↗
›Apr 1, 2025device 510k521d agoAdvalight Aps — AdvaTx (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoScientia Vascular, Inc. — Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoGigaalaser Company , Ltd. — Medical Diode Laser Systems (THEIA808) (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoTaiwan Medical Electronics Co., Ltd. — STOPWET iontophoresis apparatus (SW01) (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoIntuitive Surgical, Inc. — da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (510k cleared)INTUITIVE SURGICAL INC

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoEssity Higiene Y Salud Mexico. S.A. DE C.V. — SABA Tampons (510k cleared)

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoOrthoPediatrics Corp. — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (510k cleared)ORTHOPEDIATRICS CORP

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoGE Healthcare — MR Contour DL (510k cleared)HCA Healthcare, Inc.

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoCareglove Global Sdn. Bhd. — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗
›Apr 1, 2025device 510k521d agoEMA Aesthetics , Ltd. — Préime DermaFacial (MicroT) (510k cleared)

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

full page →fda device 510k ↗
›Apr 2, 2025approval520d agoVANRAFIA (ATRASENTAN HYDROCHLORIDE) — FDA approvalatrasentan hydrochloride

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →atrasentan hydrochloride →fda approvals ↗
›Apr 2, 2025approval520d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: NANJING KING FRIEND. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗
›Apr 2, 2025approval520d agoLIDOCAINE HYDROCHLORIDE — FDA approvalInternational Medication Systems Ltd

Sponsor: ANTHEA PHARMA. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗
›Apr 2, 2025recall520d agoA-S Medication Solutions LLC recall (Cls II)A-S Medication Solutions LLC

METFORMIN HYDROCHLORIDE EXTENDED- RELEASE 500MG, 180 TABLETS, Packaged BY: A-S Medication Solutions, Libertyville, IL 60048 NDC 50090-1494-3. — Reason: Presence of Foreign Tablets/Capsules. — Status: Ongoing

full page →fda recalls ↗
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$NVS162.46+0.75%
$MDCE0.00020.00%
$AZN161.63-0.52%
$PYPD5.3000-0.56%
$AMRX18.06+2.15%
$CODX1.51000.00%
$VANI1.6000+18.52%
$TRAW
$SNN28.66-1.07%
$NVS162.46+0.75%
$JNJ275.21+1.48%
$ISRG371.88+0.71%
$KIDS
$HCA402.06-2.79%
$TRAW