Calendar

Week of Jan 12, 2026

Jan 13, 2026device 510k212d agoDmp Dental Industry S.A. — Bright Cavity Liner (510k cleared)

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

Jan 13, 2026device 510k212d agoStryker Endoscopy — Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (510k cleared)

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

full page →fda device 510k ↗

Jan 13, 2026device 510k212d agoKossan International Sdn Bhd — Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid (510k cleared)Teva Pharmaceuticals USA Inc

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

full page →fda device 510k ↗

Jan 13, 2026device pma212d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, Jawline indication (PMA supplement)Sustained Therapeutics Inc

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoBoston Scientific Corporation — Axonics Sacral Neuromodulation System (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati (PMA supplement)

Supplement type: 30-Day Notice. Product code: MVK. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoABBOTT MEDICAL — Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PMP. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jan 13, 2026device pma212d agoABBOTT MEDICAL — Eterna SCS and Proclaim SCS Systems (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Jan 13, 2026device pma212d agoMerz North America, Inc. — COAPTITE (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoFarapulse, Inc. — FARAPULSE Pulsed Field Ablation System (FARAPULSE) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QZI. Advisory committee: CV. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device pma212d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Jan 13, 2026device recall212d agoMedtronic Perfusion Systems device recall (Cls II)

Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1 — Reason: During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026device recall212d agoLaerdal Medical Corporation device recall (Cls II)

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152; — Reason: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026device recall212d agoBaxter Healthcare Corporation device recall (Cls II)Baxter Healthcare Corp

Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A — Reason: Pumps were released without full testing being performed, including occlusion alarm testing. — Status: Ongoing

full page →fda device recalls ↗

Jan 13, 2026grant212d agoBECKMAN RESEARCH INSTITUTE/CITY OF HOPE — The role of ALKBH5-mediated RNA demethylation in the maintenance of genomic s...City of Hope

DK grant. $450,479. PI: Zhijian Qian

full page →nih reporter ↗

Jan 14, 2026approval211d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoOLANZAPINE AND FLUOXETINE HYDROCHLORIDE (FLUOXETINE HYDROCHLORIDE) — FDA approvalEpic Pharma LLC

Sponsor: TEVA PHARMS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoMEN'S ROGAINE (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: AEROSOL, FOAM. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: MSN. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval211d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval211d agoROGAINE (FOR WOMEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: AMNEAL. Form: TABLET. Route: ORAL

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval211d agoFLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (FLUCONAZOLE) — FDA approvalDiflucan

Sponsor: HOSPIRA. Form: INJECTABLE. Route: INJECTION

full page →Diflucan →fda approvals ↗

Jan 14, 2026approval211d agoAVTOZMA (TOCILIZUMAB-ANOH) — FDA approvalAVTOZMA

Sponsor: CELLTRION INC. Form: INJECTABLE. Route: INTRAVENOUS

full page →AVTOZMA →fda approvals ↗

Jan 14, 2026approval211d agoMYCOPHENOLATE MOFETIL — FDA approvalMYCOPHENOLATE MOFETIL

Sponsor: AUROBINDO PHARMA. Form: TABLET. Route: ORAL

full page →MYCOPHENOLATE MOFETIL →fda approvals ↗

Jan 14, 2026approval211d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoGLEEVEC (IMATINIB MESYLATE) — FDA approvalImatinib Mesylate Shilpa

Sponsor: NOVARTIS. Form: TABLET. Route: ORAL

full page →Imatinib Mesylate Shilpa →fda approvals ↗

Jan 14, 2026approval211d agoGABAPENTIN — FDA approvalAlmatica Pharma LLC

Sponsor: LAURUS. Form: CAPSULE. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoELTROMBOPAG OLAMINE — FDA approvalELTROMBOPAG OLAMINE

Sponsor: SOMERSET THERAPS LLC. Form: TABLET

full page →ELTROMBOPAG OLAMINE →fda approvals ↗

Jan 14, 2026approval211d agoELTROMBOPAG OLAMINE — FDA approvalZydus Therapeutics Inc

Sponsor: ZYDUS PHARMS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoLIRAGLUTIDE — FDA approvalNovo Nordisk Inc

Sponsor: ORBICULAR. Form: SOLUTION. Route: SUBCUTANEOUS

full page →fda approvals ↗

Jan 14, 2026approval211d agoTOREMIFENE CITRATE — FDA approvalTOREMIFENE CITRATE

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →TOREMIFENE CITRATE →fda approvals ↗

Jan 14, 2026approval211d agoMYCOPHENOLATE SODIUM — FDA approvalmycophenolate sodium DR

Sponsor: AUROBINDO PHARMA LTD. Form: TABLET, DELAYED RELEASE. Route: ORAL

full page →mycophenolate sodium DR →fda approvals ↗

Jan 14, 2026approval211d agoROGAINE EXTRA STRENGTH (FOR MEN) (MINOXIDIL) — FDA approvalVeradermics, Inc

Sponsor: KENVUE BRANDS. Form: SOLUTION. Route: TOPICAL

full page →fda approvals ↗

Jan 14, 2026approval211d agoSITAGLIPTIN PHOSPHATE — FDA approvalSITAGLIPTIN PHOSPHATE

Sponsor: SANDOZ. Form: TABLET. Route: ORAL

full page →SITAGLIPTIN PHOSPHATE →fda approvals ↗

Jan 14, 2026approval211d agoIRBESARTAN AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalALDACTAZIDE

Sponsor: ALEMBIC. Form: TABLET. Route: ORAL

full page →ALDACTAZIDE →fda approvals ↗

Jan 14, 2026approval211d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval211d agoMETHOTREXATE SODIUM PRESERVATIVE FREE (METHOTREXATE SODIUM) — FDA approvalPFIZER INC

Sponsor: PHARMACHEMIE BV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Jan 14, 2026approval211d agoANAGRELIDE HYDROCHLORIDE — FDA approvalANAGRELIDE HYDROCHLORIDE

Sponsor: RISING. Form: CAPSULE. Route: ORAL

full page →ANAGRELIDE HYDROCHLORIDE →fda approvals ↗

Jan 14, 2026recall211d agoMedinatura New Mexico, inc. recall (Cls I)

ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoSpecGx, LLC recall (Cls II)SpecGx LLC

Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01. — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoImprimis NJOF, LLC recall (Cls II)Fosun Pharma USA Inc

Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoMedinatura New Mexico, inc. recall (Cls I)

ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863 — Reason: Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoSignature Formulations, LLC recall (Cls II)

ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoSpecGx, LLC recall (Cls II)SpecGx LLC

Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493 — Reason: Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoSignature Formulations, LLC recall (Cls II)

ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA — Reason: cGMP Deviations — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoAvKARE recall (Cls II)AvKare LLC

Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15 — Reason: Out of specification for dissolution. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoAlembic Pharmaceuticals Limited recall (Cls III)Alembic Pharmaceuticals Inc

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30 — Reason: Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit. — Status: Ongoing

full page →fda recalls ↗

Jan 14, 2026recall211d agoImprimis NJOF, LLC recall (Cls II)OCULAR THERAPEUTIX, INC

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01. — Reason: Presence of particulate matter - Glass like particles. — Status: Ongoing

full page →fda recalls ↗

← prev

page 8 of 205

Week of Jan 12, 2026