Calendar

pharmadog

Week of Dec 15, 2025

Dec 18, 2025approval255d agoNICARDIPINE HYDROCHLORIDE — FDA approvalNICARDIPINE HYDROCHLORIDE

Sponsor: CHENGDU SHUODE. Form: INJECTABLE. Route: INJECTION

full page →NICARDIPINE HYDROCHLORIDE →fda approvals ↗

Dec 18, 2025approval255d agoNUFYMCO (RANIBIZUMAB-LEYK) — FDA approvalNUFYMCO

Sponsor: FORMYCON AG. Form: INJECTION

full page →NUFYMCO →fda approvals ↗

Dec 18, 2025approval255d agoVARENICLINE TARTRATE — FDA approvalVARENICLINE TARTRATE

Sponsor: LUPIN LTD. Form: TABLET. Route: ORAL

full page →VARENICLINE TARTRATE →fda approvals ↗

Dec 18, 2025approval255d agoTENOFOVIR DISOPROXIL FUMARATE — FDA approvalTENOFOVIR DISOPROXIL FUMARATE

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

full page →TENOFOVIR DISOPROXIL FUMARATE →fda approvals ↗

Dec 18, 2025approval255d agoHALOPERIDOL — FDA approvalCreekwood Pharmaceutical Inc

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

full page →fda approvals ↗

Dec 18, 2025device 510k255d agoEdwards Lifesciences — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (510k cleared)Edwards Lifesciences Corp

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoOvesco Endoscopy AG — OTSCneo System Set (100.03n-14n, 100.27n-31n) (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoOlympus Medical Systems Corporation — Single Use Cytology Brush V (BC-V600P-3010) (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoNatec Medical , Ltd. — Amethyst HP PTA OTW 0.035 Catheter (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoFresenius Medical Care Renal Therapies Group, LLC — FX CorAL 40; FX CorAL 50 (510k cleared)Fresenius Medical Care AG

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoTomey Corporation — Tomey Optical Biometer OA-2000 (OA-2000) (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoEndovascular Engineering, Inc. — Helo Thrombectomy System (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoJiangsu Jiyuan Medical Technology Co., Ltd. — ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope (SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C) (510k cleared)Jiangsu Maoxing Technology Co Ltd

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoMedizin Produkte Neustadt GmbH (Mpn) — Dental Cone; Dental Sponge (510k cleared)

Product code: OLR. Advisory committee: Unknown. Type: Special

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoTerumo Medical Products (Hangzhou) Co., Ltd. — Midline Catheter (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoCrescom Co., Ltd. — MediAI-BA (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoPark Dental Research Corp. — Park Dental Nylon MAD (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoReflexion Medical, Inc. — RefleXion Medical Radiotherapy System, Reflexion X2 (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoABBOTT MEDICAL — Assert-IQ (DM5100) (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoUltrasight , Ltd. — PVAD IQ Software (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoSimda Co., Ltd. — SIMDA Abutments (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device 510k255d agoErbe Elektromedizin GmbH — MOVIVA® Hybrid Ablation Probe (510k cleared)

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

full page →fda device 510k ↗

Dec 18, 2025device pma255d agoRenata Medical, Inc. — Minima Stent System (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBiotronik, Inc. — Acticor Sky HF-T 481986, Rivacor Sky HF-T 481991, Rivacor Rise HF-T 482017, Rivacor Aura HF-T 482013, Acticor Sky HF-T Q (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoSpectranetics Corp. — ELCA Coronary Atherectomy Catheters (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBiotronik, Inc. — Acticor Sky DR-T 481987, Rivacor Sky DR-T 481982, Rivacor Rise DR-T 482018, Rivacor Aura DR-T 482014 (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: MRM. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoCarl Zeiss Meditec, Inc. — VisuMax; VISUMAX 800 (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: OTL. Advisory committee: OP. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoNeomend, Inc. — TRIDYNE Vascular Sealant (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBoston Scientific Corp — WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoChannel Medsystems, Inc. — Cerene® Cryotherapy Device (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MNB. Advisory committee: OB. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoZOLL Medical Corporation — X Series®; Propaq MD®; AED 3 BLS; Zenix Professional Defibrillators (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

Supplement type: Normal 180 Day Track No User Fee. Product code: OZP. Advisory committee: CH. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBiotronik, Inc. — Solia S 53 377177; Solia S 60 377179 (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: MHY. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Dec 18, 2025device pma255d agoZOLL Medical Corporation — AED 3 (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: MKJ. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoIntrinsic Therapeutics — Barricaid® Annular Closure Device (PMA supplement)Insignis Therapeutics Inc

Supplement type: 30-Day Notice. Product code: QES. Advisory committee: OR. Decision: OK30

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBaxter Bio Science — Coseal Applicator Tips (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoNeomend, Inc. — PROGEL Pleural Air Leak Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: AN. Decision: OK30

full page →fda device pma ↗

Dec 18, 2025device pma255d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify, and Vec (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

full page →fda device pma ↗

Dec 18, 2025device pma255d agoSymatese — Evolysse® FORM (PMA supplement)

Supplement type: Normal 180 Day Track No User Fee. Product code: LMH. Advisory committee: SU. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBoston Scientific Corp — WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Real-Time Process. Product code: LGW. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoBiotronik, Inc. — Acticor Sky VR-T 481989, Rivacor Sky VR-T 481984, Rivacor Rise VR-T 482020, Rivacor Aura VR-T 482015, Acticor Sky VR-T D (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoOcclutech Holding AG — Occlutech ASD Occluder; Occlutech Pistol Pusher (OPP); Occlutech ASD Occluder Procedure Pack (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoSpectranetics (Philips) — GlideLight Laser Sheath (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device pma255d agoDepuy, Inc. — ATTUNE Revision Rotating Platform (RP) Knee System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NJL. Advisory committee: OR. Decision: APPR

full page →fda device pma ↗

Dec 18, 2025device pma255d agoVasorum, Ltd. — CELT ACD Vascular Closure Device (PMA supplement)

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

full page →fda device pma ↗

Dec 18, 2025device recall255d agoWilson-Cook Medical Inc. device recall (Cls II)PATH

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts. — Reason: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting. — Status: Ongoing

full page →fda device recalls ↗

Dec 18, 2025device recall255d agoCommunity Products, LLC device recall (Cls II)

Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. — Reason: Potential for fraying on the body support strap. — Status: Ongoing

full page →fda device recalls ↗

Dec 18, 2025device recall255d agoCommunity Products, LLC device recall (Cls II)

Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion. — Reason: Potential for fraying on the body support strap. — Status: Ongoing

full page →fda device recalls ↗

Dec 18, 2025device recall255d agoVascutek, Ltd. device recall (Cls II)

Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE, 631506PE, 632524PE, 636007PE, 631512PE, 636012PE, 636014PE, 632211P50E, 633016PE, 631407PE, 631809PE, 632010PE, 631608P50E, 632520PE, 632412PE, 631510PE, 635022PE, 631224PE, 632412P50E, 631507PE, 633014PE, 632010P50E, 635020PE, 631809P50E. Gelweave, REF: 736038E, 736036E, 736034E, 736032ST/10DE, 736032E, 736030ST/10DE, 736030E, 736028ST/10DE, 736028E, 736026ST/10DE, 736026E, 736024ST/10DE, 736024E, 736022ST/10DE, 736022E, 736020E, 736018E, 736016E, 736014E, 736012E, 736010E, 736008E, 736006E, 735034ST/8AE, 735034/8RME, 735034/10SEE, 735034/10RME, 735032STE, 735032ST/8AE, 735032/8SE, 735032/8RME, 735032/10SEE, 735032/10RME, 735030STE, 735030ST/8AE, 735030/8SE, 735030/8RME, 735030/10SEE, 735030/10RME, 735028STE, 735028ST/8AE, 735028E, 735028/8SE, 735028/8RME, 735028/10RME, 735026STE, 735026ST/8AE, 735026E, 735026/8SE, 735026/8RME, 735026/10RME, 735024STE, 735024ST/8AE, 735024E, 735024/8SE, 735024/8RME, 735024/10SEE, 735024/10RME, 735022STE, 735022E, 735022/8SE, 735022/8RME, 735020E, 735020/8RME, 735018E, 734038E, 734036E, 734034E, 734034CX4RMSE, 734034/8E, 734034/10E, 734032E, 734032CX4RMSE, 734032/8E, 734032/10E, 734030E, 734030CX4RMSE, 734030/8E, 734030/10E, 734028CX4RMSE, 734028/8E, 734028/10E, 734026CX4RMSE, 734026/8E, 734026/10E, 734024CX4RMSE, 734024/8E, 734024/10E, 734022CX4RMSE, 734022/8E, 734022/10E, 734020CX4RMSE, 734020/8E, 734020/10E, 734018/8E, 73341088E, 73341088/8RME, 73341088/8E, 73341088/10RME, 73341088/10E, 73321488/8ARME, 7332148/10RMFE, 7332148/10RMEE, 733212810/10STDE, 7332128/10RMFE, 7332128/10RMEE, 73321088E, 73321088/8SDE, 73321088/8RME, 73321088/8E, 73321088/10RME, 73321088/10E, 7330888/8E, 7330668/6E, 733038E, 733036E, 733034E, 733032E, 733030E, 733028E, 733026E, 733024E, 733024/6AE, 733022E, 733022/6AE, 733020E, 733020/6AE, 733018E, 733018/6AE, 733016E, 733014E, 73301488/8ARME, 7330148/10RMFE, 7330148/10RMEE, 73301412/10ETE, 733012E, 733012810/10STDE, 7330128/10RMFE, 7330128/10RMEE, 733010E, 73301088E, 73301088/8SDE, 73301088/8RME, 73301088/8E, 73301088/10RME, 73301088/10E, 733010108/8S4E, 733010108/8RME, 733010/10RME, 733008E, 733006E, 7328888/8E, 7328668/6E, 73281488/8ARME, 7328148/10RMEE, 73281412/10ETE, 73281288/8E, 732812810/10STDE, 7328128/10RMFE, 7328128/10RMEE, 73281088E, 73281088/8SDE, 73281088/8RME, 73281088/8E, 73281088/10RME, 73281088/10E, 732810108/8S4E, 7326888/8E, 7326668/6E, 73261488/8ARME, 7326148/10RMEE, 732612810/10STDE, 7326128/10RMFE, 7326128/10RMEE, 73261088E, 73261088/8SDE, 73261088/8RME, 73261088/8E, 73261088/10RME, 73261088/10E, 732610108/8S4E, 732610/10RME, 732528E, 732526E, 732524E, 732522E, 732520E, 732518E, 7324888/8E, 7324668/6E, 73241488/8ARME, 7324148/10RMEE, 732412E, 732412810/10STDE, 7324128/10RMEE, 732412/6E, 73241088E, 73241088/8SDE, 73241088/8RME, 73241088/8E, 73241088/10RME, 73241088/10E, 732410108/8S4E, 73221488/8ARME, 732214/10/10CRME, 732212810/10STDE, 732212/10/8CRME, 732212/10/8ARME, 732211E, 73221088/8RME, 73221088/8E, 73221088/10E, 732210108/8S4E, 7320888/8E, 7320668/6E, 732038E, 732034E, 732034CX4RME, 732034/8E, 732034/10E, 732032E, 732032CX4RME, 732032/8E, 732032/10E, 732030E, 732030CX4RME, 732030/8E, 732030/10E, 732028CX4RME, 732028/8E, 732028/10E, 732026CX4RME, 732026/8E, 732026/10E, 732024CX4RME, 732024/8E, 732024/10E, 732022/10E, 732014/8X2E, 732014/8X2AE, 732014/10X2E, 732014/10X2AE, 732012810/10STDE, 732012/8X2E, 732012/8X2AE, 732012/10X2E, 732010E, 73201088/8RME, 73201088/8E, 732010108/8S4E, 732010/6E, 731809E, 731809/6E, 731608XL55E, 731608E, 731608/8/10RME, 731608/6E, 731608/10/10RME, 731516E, 731514E, 731512E, 731510E, 731508E, 731506E, 7314108/10RME, 731407XL55E, — Reason: Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of manufacture) but it was incorrectly calculated from device packaging. — Status: Ongoing

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Week of Dec 15, 2025