| Zamenix™ P (K253505) | Roen Surgical, Inc. | 2026-08-07 |
| Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702) | Intuitive Surgical, Inc. | 2026-08-07 |
| EW10-EC02 Endoscopy Support Program (K260567) | Fujifilm Corporation | 2026-08-07 |
| Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 30mm (1530VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 15G x 38mm (1538VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 30mm (1630VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 16G x 38mm (1638VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 30mm (1730VSMM); Ritus™ Safety Fistula Cannula with Anti-Reflux Valve 17G x 38mm (1738VSMM) (K253469) | Mozarc Medical Us, LLC | 2026-08-06 |
| CAD - Lower GI (EC07-01) (K252853) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 |
| Transurethral Catheter Safety Valve (TUCSV) (80050) (K260919) | Class Medical , Ltd. | 2026-08-05 |
| Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18). (K260737) | Convatec | 2026-08-05 |
| Rusch Latex Gold Foley Catheter (K262056) | Teleflex Medical Sdn. Bhd. | 2026-08-05 |
| Marrow Marxman (K260572) | Medimetrix, LLC | 2026-08-04 |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K261183) | Olympus Medical Systems Corporation | 2026-07-31 |
| da Vinci Surgical System, Model IS5000 (K261824) | Intuitive Surgical, Inc. | 2026-07-31 |
| Stone Clear (BWSC-LP9-02) (K262200) | Sonomotion, Inc. | 2026-07-29 |
| Revi System (K253651) | Bluewind Medical , Ltd. | 2026-07-28 |
| ELISIO™-HX (K261399) | Nipro Medical Corporation | 2026-07-28 |
| ARCHIMEDES Biodegradable Stent (Medium) (K260835) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2026-07-27 |
| Careflux H60;Careflux H70;Careflux V500 (K261267) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-07-24 |
| PerfusiX-Imaging (K254180) | LIMIS Development B.V. | 2026-07-24 |
| EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device) (K253541) | Medical Impact | 2026-07-24 |
| VS-370CF, VS-370CT (K262152) | VISION MEDICAL Co., Ltd. | 2026-07-24 |
| Perfadex Plus (K261644) | Xvivo Perfusion AB | 2026-07-23 |
| BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR) (K260516) | MacroLux Medical Technology Co., Ltd. | 2026-07-20 |
| ENDOSCOPE HOLDER (182214) (K261573) | Aktormed GmbH | 2026-07-20 |
| LED LCD Monitor (OEV-271H) (K261614) | Lg Electronics.Inc | 2026-07-17 |
| LoFric Origo Pro Coudé (K261658) | Wellspect AB | 2026-07-17 |
| Universal Seal (5-12 mm) (K261249) | Intuitive Surgical, Inc. | 2026-07-14 |
| Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric Tube - 20 French (0092100); Blakemore Esophageal-Nasogastric Tube - 16 French (0092300) (K253514) | C.R. Bard, Inc. | 2026-07-10 |
| Luja Soft (K262045) | Coloplast A.S. | 2026-07-07 |
| FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (K261880) | Fujifilm Corporation | 2026-07-02 |
| Insufflation Retention Device (IRD) (11173-325-101) (K261587) | BPEndo, LLC | 2026-07-02 |
| Enteral Syringe (20ml, 60ml) (K252483) | Chirana T.Injecta,A.S. | 2026-07-01 |
| Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019 (K253393) | Hangzhou AGS MedTech Co., Ltd. | 2026-06-24 |
| HD Camera Head OLYMPUS CH-S200-08-LB (K261260) | Olympus Medical Systems Corporation | 2026-06-24 |
| Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR) (K260394) | Hangzhou Jimushi Meditech Co., Ltd. | 2026-06-24 |
| Urocross Expander System (UES-2018-C1) (K261342) | Prodeon Medical, Inc. | 2026-06-22 |
| Pelvic Muscle Trainer (KM510, KM516B) (K260178) | Shenzhen Konmed Technology Co., Ltd. | 2026-06-18 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| DYNE PORT (K252933) | Dyne Medical Group, Inc. | 2026-06-12 |
| FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air) (K260710) | FloShield, Inc. | 2026-06-11 |
| “Tech-Image” Video Endoscope System (K260414) | Tech-Image CO., LTD. | 2026-06-10 |
| TroKit Laparoscope Lens Wiper (K253994) | TroCare, LLC | 2026-06-04 |
| Instrument Exit Point on Touch Surgery™ Aide (K253984) | Covidien, LLC | 2026-06-04 |
| KARL STORZ Endoscopic Accessories for Urology (K252800) | Karl Storz SE & CO. KG | 2026-06-03 |
| Inno-Port Disposable Bladed Trocar (K252532) | Taiwan Surgical Corporation | 2026-06-02 |
| VI°Port™ Liver Preservation System (K260456) | Traferox Technologies, Inc. | 2026-06-01 |
| Injection Needle (K260262) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-05-29 |
| BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit (K254076) | C.R. Bard, Inc. | 2026-05-29 |
| GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (K261369) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 |
| Disposable Endoscopic Distal Attachments (K260423) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 |
| 4K NIR/ICG Imaging System (K260318) | Zhejiang Healnoc Technology Co., Ltd. | 2026-05-26 |
| MediBot Needle Driver Uno (K260183) | Parallel Robotics, LLC | 2026-05-24 |
| Atmo Gas Capsule System (K253569) | Atmo Biosciences, Ltd. | 2026-05-22 |
| da Vinci Firefly Imaging System (K260695) | Intuitive Surgical | 2026-05-22 |
| Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K260580) | Olympus Medical Systems Corp. | 2026-05-21 |
| OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical, (K260649) | Olympus Winter & Ibe GmbH | 2026-05-21 |
| Sphincterotome (K260962) | Taewoong Medical Co., Ltd. | 2026-05-21 |
| Laport (K252985) | Sejong Medical Co., Ltd. | 2026-05-19 |
| Coude Sleeved IC; Coude Plus Sleeved IC (K253295) | Hollister Incorporated | 2026-05-18 |
| NovaLine Tubing Set for Hemodialysis (BL 124) (K252423) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2026-05-15 |
| NxStage System One with NxView (K252377) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-05-15 |
| Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L) (K252601) | Hunan Accurate Bio-Medical Technology Co., Ltd. | 2026-05-14 |
| Senhance Ultrasonic System (K254192) | Asensus Surgical | 2026-05-12 |
| Promisemed VeriEcto Automatic Biopsy Needles (K261196) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 |
| CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465) (K253696) | Verathon Medical (Canada) Ulc | 2026-05-11 |
| KARL STORZ Trocars with Valve Seals (K254228) | Karl Storz SE & CO. KG | 2026-05-11 |
| Disposable Stone Retrieval Balloon Catheter (K253013) | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-05-08 |
| MiroCam® Capsule Endoscope System (K252617) | Intromedic Co., Ltd. | 2026-05-08 |
| Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) (K252552) | Shenzhen Changkun Technology Co., Ltd. | 2026-05-06 |
| Ancora-SB (K260314) | Aspero Medical, Inc. | 2026-05-01 |
| Aurie System (DEN250023) | Cathbuddy, Inc. | 2026-04-30 |
| 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) (K252858) | Kms Medical Technology Co., Ltd. | 2026-04-30 |
| Break Wave (K261086) | Sonomotion, Inc. | 2026-04-29 |
| Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) (K252831) | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 2026-04-28 |
| LoFric Elle Pro (K260999) | Wellspect AB | 2026-04-24 |
| Dilation Balloon Catheter (K253832) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| Visualized Access and Delivery Catheter; PB Digital Controller (K252492) | Micro-Tech (Nanjing) Co., Ltd. | 2026-04-24 |
| EvoEndo Single-Use Endoscopy System (K260573) | EvoEndo, Inc. | 2026-04-21 |
| SmartSurgN Visualization System (K242163) | SmartsurgN, Inc. | 2026-04-20 |
| PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) (K252334) | Pontemedag | 2026-04-17 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302AA HD-endoscope, 4 x 302 mm, view. Dir. 0°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BA HD-endoscope, 4 x 302 mm, view. Dir. 30°, wide angle, autoclavable); Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302BSA HD-endoscope, 4 x 302 mm, view. Dir. 30°, (K253892) | Strauss Surgical USA | 2026-04-16 |
| Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) (K253537) | Bright Uro, Inc. | 2026-04-16 |
| Endoflux™ Biliary & Pancreatic Stent Sets (K251658) | Medi-Globe GmbH | 2026-04-16 |
| CVAC Aspiration System (K260965) | Calyxo, Inc. | 2026-04-13 |
| Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) (K252929) | Anhui Happiness Workshop Instruments Co., Ltd. | 2026-04-09 |
| Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap (K253268) | CMT Health PTE., Ltd. | 2026-04-08 |
| Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (K260197) | Suzhou Shenyun Medical Equipment Co., Ltd. | 2026-04-08 |
| Hemoclip (K252270) | Hangzhou AGS MedTech Co., Ltd. | 2026-04-08 |
| TL-10 Laparoscopic Scope Cleaner (K260089) | Scopix , Ltd. | 2026-04-08 |
| PrimeSight UltraView System (K253905) | Cogentix Medical, Inc. | 2026-04-07 |
| ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) (K260521) | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 |
| in2 Smart (in2S) (K252809) | Virility Medical , Ltd. | 2026-04-06 |
| MAGENTIQ-COLO (ME-APDS) (K260724) | Magentiq Eye, Ltd. | 2026-04-03 |
| Single-use Video Scope; PB Digital Controller (K254153) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-04-03 |
| Disposable Stone Extraction Basket (K253056) | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-04-03 |
| GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women (K252943) | Convatec Limited | 2026-04-01 |
| InjecSURE Injection System (K253598) | Carbon Medical Technologies, Inc. | 2026-03-31 |
| Strauss Surgical cystoscope, hysteroscope and accessories Instruments (K260271) | American Medical Endoscopy, Inc. | 2026-03-27 |
| Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (K252926) | Restore Robotics | 2026-03-26 |
| Percutaneous Endoscopic Gastrostomy (PEG) Kit (K254170) | Degania Silicone , Ltd. | 2026-03-20 |
| Disposable Distal Cap (K253139) | Mirco-Tech (Nanjing) Co., Ltd. | 2026-03-19 |
| ELISIO™-H (K260533) | Nipro Medical Corporation | 2026-03-19 |