Calendar

pharmadog

Week of Dec 15, 2025

Dec 18, 2025device 510k254d agoTomey Corporation — Tomey Optical Biometer OA-2000 (OA-2000) (510k cleared)

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

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Dec 18, 2025device 510k254d agoEndovascular Engineering, Inc. — Helo Thrombectomy System (510k cleared)

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

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Dec 18, 2025device 510k254d 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

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Dec 18, 2025device 510k254d agoMedizin Produkte Neustadt GmbH (Mpn) — Dental Cone; Dental Sponge (510k cleared)

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

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Dec 18, 2025device 510k254d agoTerumo Medical Products (Hangzhou) Co., Ltd. — Midline Catheter (510k cleared)

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

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Dec 18, 2025device 510k254d agoCrescom Co., Ltd. — MediAI-BA (510k cleared)

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

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Dec 18, 2025device 510k254d agoPark Dental Research Corp. — Park Dental Nylon MAD (510k cleared)

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

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Dec 18, 2025device 510k254d agoReflexion Medical, Inc. — RefleXion Medical Radiotherapy System, Reflexion X2 (510k cleared)

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

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Dec 18, 2025device 510k254d agoABBOTT MEDICAL — Assert-IQ (DM5100) (510k cleared)

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

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Dec 18, 2025device 510k254d agoUltrasight , Ltd. — PVAD IQ Software (510k cleared)

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

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Dec 18, 2025device 510k254d agoSimda Co., Ltd. — SIMDA Abutments (510k cleared)

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

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Dec 18, 2025device 510k254d agoErbe Elektromedizin GmbH — MOVIVA® Hybrid Ablation Probe (510k cleared)

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

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Dec 18, 2025device pma254d agoRenata Medical, Inc. — Minima Stent System (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoSpectranetics Corp. — ELCA Coronary Atherectomy Catheters (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoNeomend, Inc. — TRIDYNE Vascular Sealant (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoChannel Medsystems, Inc. — Cerene® Cryotherapy Device (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoZOLL Medical Corporation — AED 3 (PMA supplement)

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

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Dec 18, 2025device pma254d agoIntrinsic Therapeutics — Barricaid® Annular Closure Device (PMA supplement)Insignis Therapeutics Inc

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

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Dec 18, 2025device pma254d agoBaxter Bio Science — Coseal Applicator Tips (PMA supplement)

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

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Dec 18, 2025device pma254d agoNeomend, Inc. — PROGEL Pleural Air Leak Sealant (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoSymatese — Evolysse® FORM (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoSpectranetics (Philips) — GlideLight Laser Sheath (PMA supplement)

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

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Dec 18, 2025device pma254d 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

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Dec 18, 2025device pma254d agoVasorum, Ltd. — CELT ACD Vascular Closure Device (PMA supplement)

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

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Dec 18, 2025device recall254d 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

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Dec 18, 2025device recall254d 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

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Dec 18, 2025device recall254d 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

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Dec 18, 2025device recall254d 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

Dec 18, 2025device recall254d agoCommunity Products, LLC device recall (Cls II)

Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. 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. The low base variant includes smaller casters and lower base frame so that the legs fit underneath beds. — Reason: Potential for fraying on the body support strap. — Status: Ongoing

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Dec 18, 2025grant254d agoSTATE UNIVERSITY OF NEW YORK AT BUFFALO — Investigating the role of peripheral nerve damage in chronic Toxoplasma infec...

AI grant. $35,157. PI: Caleb Buerger

full page →nih reporter ↗

Dec 19, 2025approval253d agoMYQORZO (AFICAMTEN) — FDA approvalaficamten

Sponsor: CYTOKINETICS. Form: TABLET. Route: ORAL

full page →aficamten →fda approvals ↗

Dec 19, 2025approval253d agoMOUNJARO (TIRZEPATIDE) — FDA approvalZEPBOUND

Sponsor: ELI LILLY AND CO. Form: SOLUTION. Route: SUBCUTANEOUS

full page →ZEPBOUND →fda approvals ↗

Dec 19, 2025approval253d agoDECITABINE — FDA approvalDECITABINE

Sponsor: RELIANCE LIFE SCI. Form: INJECTABLE. Route: INTRAVENOUS