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Week of Dec 22, 2025

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Dec 22, 2025device pma241d agoMedtronic, Inc. — SynchroMed Infusion System; Ascenda Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

full page →fda device pma ↗

Dec 22, 2025device pma241d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

Supplement type: 30-Day Notice. Product code: PHP. Advisory committee: MG. Decision: OK30

full page →fda device pma ↗

Dec 22, 2025device recall241d agoLSL Healthcare Inc. device recall (Cls II)HCA Healthcare, Inc.

LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2519CP, medical procedure convenience kit — Reason: BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators. — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710DF282CRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/ EZ Steer BD710DF282RRH BD710FJ282RRH; Webster CS Catheter 10 Electrodes, 2-8-2mm Spacing w/AutoID w/ EZ Steer BD710FJ282CRH; — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoPhilips North America device recall (Cls II)

Patient Information Center iX; Software Version Number: 4.5.0 — Reason: A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system. — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems 10439011RH — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH; — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025device recall241d agoMedline Industries, LP device recall (Cls I)

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x 90cm D087031RH 20197344019554¿ — Reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025 — Status: Ongoing

full page →fda device recalls ↗

Dec 22, 2025grant241d agoUNIV OF NORTH CAROLINA CHAPEL HILL — Integrative Predictors of Temporomandibular Degenerative Joint Disease

DE grant. $698,865. PI: Lucia H Cevidanes

full page →nih reporter ↗

Dec 22, 2025grant241d agoEMORY UNIVERSITY — Critical Care Training ProgramEmory University

GM grant. $3,000. PI: Craig M Coopersmith

full page →nih reporter ↗

Dec 22, 2025grant241d agoUNIVERSITY OF CALIFORNIA LOS ANGELES — Systems Genetics of Vascular Smooth Muscle PhenotypesUniversity of California Los Angeles

HL grant. $522,130. PI: Mete Civelek

full page →nih reporter ↗

Dec 22, 2025grant241d agoBOSTON UNIVERSITY MEDICAL CAMPUS — Integrating Multi-Omics to Uncover Shared Mechanisms Linking Physical Frailty...

AG grant. $49,438. PI: Jiachen Chen

full page →nih reporter ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

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

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval240d agoHYDROCODONE BITARTRATE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAmneal Pharmaceuticals, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval240d agoEPHEDRINE SULFATE — FDA approvalFresenius Kabi USA LLC

Sponsor: CIVICA. Form: SOLUTION. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: CHARTWELL. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoNALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE (NALOXONE HYDROCHLORIDE) — FDA approvalLupin Ltd

Sponsor: SUN PHARM INDS LTD. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoIDACIO (ADALIMUMAB-AACF) — FDA approvalIDACIO

Sponsor: FRESENIUS KABI USA. Form: INJECTABLE. Route: SUBCUTANEOUS

full page →IDACIO →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

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

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoORLYNVAH (PROBENECID) — FDA approvalLannett Co Inc

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

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE HYDROCHLORIDE — FDA approvalAmneal Pharmaceuticals, Inc.

Sponsor: ALKEM LABS LTD. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoMETHADOSE (METHADONE HYDROCHLORIDE) — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: SPECGX LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ELITE LABS INC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoPROMETHAZINE WITH CODEINE (CODEINE PHOSPHATE) — FDA approvalCosette Pharmaceuticals Inc

Sponsor: PHARM ASSOC. Form: SYRUP. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoYONDELIS (TRABECTEDIN) — FDA approvalJOHNSON & JOHNSON

Sponsor: JANSSEN PRODS. Form: POWDER. Route: INTRAVENOUS

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: RUBICON RESEARCH. Form: TABLET. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval240d agoPYRUKYND (MITAPIVAT SULFATE) — FDA approvalAGIOS PHARMACEUTICALS, INC.

Sponsor: AGIOS PHARMS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoMETHYLENE BLUE — FDA approvalMETHYLENE BLUE

Sponsor: CHENGDU SHUODE. Form: SOLUTION. Route: INTRAVENOUS

full page →METHYLENE BLUE →fda approvals ↗

Dec 23, 2025approval240d agoORLADEYO (BEROTRALSTAT DIHYDROCHLORIDE) — FDA approvalberotralstat hydrochloride

Sponsor: BIOCRYST. Form: CAPSULE. Route: ORAL

full page →berotralstat hydrochloride →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: MYLAN. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvaltramadol hydrochloride ER

Sponsor: ACTAVIS ELIZABETH. Form: TABLET, EXTENDED RELEASE. Route: ORAL

full page →tramadol hydrochloride ER →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalAurobindo Pharma Ltd

Sponsor: SUN PHARM INDS INC. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvalGraviti Pharmaceuticals Inc

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

full page →fda approvals ↗

Dec 23, 2025approval240d agoMETHADONE HYDROCHLORIDE — FDA approvalMETHADONE HYDROCHLORIDE

Sponsor: VISTAPHARM LLC. Form: TABLET. Route: ORAL

full page →METHADONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE — FDA approvalTrigen Laboratories Inc

Sponsor: PLIVA. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: ALVOGEN. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoOXYMORPHONE HYDROCHLORIDE — FDA approvalOXYMORPHONE HYDROCHLORIDE

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →OXYMORPHONE HYDROCHLORIDE →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

Sponsor: WATSON LABS. Form: TABLET. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: AUROLIFE PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoCABLIVI (CAPLACIZUMAB-YHDP) — FDA approvalGenzyme Corp

Sponsor: ABLYNX NV. Form: INJECTABLE. Route: INJECTION

full page →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalIGC Pharma, Inc.

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

full page →fda approvals ↗

Dec 23, 2025approval240d agoPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE (CODEINE PHOSPHATE) — FDA approvalPROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Sponsor: ACTAVIS MID ATLANTIC. Form: SYRUP. Route: ORAL

full page →PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE HYDROCHLORIDE — FDA approvalANI PHARMACEUTICALS INC

Sponsor: ANI PHARMS. Form: SOLUTION. Route: ORAL

full page →fda approvals ↗

Dec 23, 2025approval240d agoTRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: RISING. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

Dec 23, 2025approval240d agoOXYCODONE AND ACETAMINOPHEN (ACETAMINOPHEN) — FDA approvalacetaminophen ER

Sponsor: EPIC PHARMA LLC. Form: TABLET. Route: ORAL

full page →acetaminophen ER →fda approvals ↗

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