| da Vinci SP Surgical System (SP1098) (K251426) | Intuitive Surgical, Inc. | 2025-10-03 |
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K251859) | Olympus Medical Systems Corporation | 2025-10-03 |
| Revolve Surgical System (K243968) | Revolve Surgical, Inc. | 2025-10-03 |
| Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) (K252806) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-10-03 |
| Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) (K251468) | Hollister Incorporated | 2025-10-03 |
| 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) (K250551) | Shenzhen Sophway Technology Co., Ltd. | 2025-10-02 |
| TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) (K251442) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2025-10-02 |
| Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal Dialysis Cycler (3014-00000-3); Archimedes Pro Disposable Tubing Set (3014-50000-1); Archimedes Standard Disposable Tubing Set (3014-50000-3); Archimedes Pro Plus Disposable Tubing Set (3014-50000-5) (K250523) | Simergent, LLC | 2025-10-02 |
| Vena MicroAngioscope™ System (K251767) | Vena Medical Holdings Corp | 2025-10-01 |
| SureTome™ SW Sphincterotome with DomeTip (K251104) | Wilson-Cook Medical | 2025-09-29 |
| FUJIFILM Stiffening Wire Device (SW-2000) (K251204) | FUJIFILM Healthcare Americas Corporation | 2025-09-26 |
| AUXILIARY WATER TUBE MAJ-855 (K251986) | Olympus Medical Systems Corporation | 2025-09-26 |
| LoFric Origo (K250659) | Wellspect AB | 2025-09-26 |
| Single-Use Biopsy Valve (MAJ-1555) (K251997) | Olympus Medical Systems Corporation | 2025-09-25 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500) (K252703) | Boston Scientific Corporation | 2025-09-24 |
| ROBOPERA (ER-R-002); ROBOPERA (ER-R-003) (K244029) | Endorobotics Co., Ltd. | 2025-09-24 |
| Resitu Slider 09 (RESL09) (K252183) | Resitu Medical AB | 2025-09-24 |
| ProVee Video Processing Unit (PV-003) (K251734) | Proverum Limited | 2025-09-24 |
| Zenflow Spring Scope (K251140) | Zenflow, Inc. | 2025-09-23 |
| SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System (K251743) | Surgical Principals, Inc. | 2025-09-22 |
| EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) (K251867) | Olympus Medical Systems Corp. | 2025-09-19 |
| Single Use Suction-Evacuation Ureteral Access Sheath (K250128) | Anhui Happiness Workshop Medical Instruments Co., Ltd. | 2025-09-19 |
| Purema H Hemoconcentrator - Pediatric (K243920) | Medica USA, Inc. | 2025-09-19 |
| Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) (K252598) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-09-15 |
| CADDIE (K252586) | Odin Medical Limited | 2025-09-12 |
| Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller (K251170) | Tangent Endoscopy, LLC | 2025-09-12 |
| UV5000 Handle (K250797) | Uroviu Corporation | 2025-09-11 |
| da Vinci SP Surgical System (SP1098) (K251817) | Intuitive Surgical, Inc. | 2025-09-10 |
| Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W) (K252180) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-09-09 |
| AquaA (K252181) | Fresenius Medical Care North America | 2025-09-09 |
| Dual Action Tissue Closure Device (K250229) | Micro-Tech (Nanjing) Co., Ltd. | 2025-09-08 |
| da Vinci Surgical System (IS5000) (K251227) | Intuitive Surgical, Inc. | 2025-09-08 |
| Ureteral Access Sheath (K250132) | Zhejiang YiGao Medical Technology Co., Ltd. | 2025-09-05 |
| Regenesis EMS Chair (K251026) | Trinity Medical Solutions | 2025-08-29 |
| da Vinci SP Surgical System (SP1098) (K251324) | Intuitive Surgical, Inc. | 2025-08-29 |
| da Vinci SP Firefly Imaging System (K252350) | Intuitive Surgical, Inc. | 2025-08-28 |
| KnoxFog Anti-fogging Device (K251068) | Uv One Hygienics, Inc. | 2025-08-27 |
| Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000) (K250049) | Seplou (Zhuhai) Co., Ltd. | 2025-08-26 |
| ClearTip FNA and FNB Types (K250994) | Finemedix Co., Ltd. | 2025-08-21 |
| EndoFix™Tissue Fixation System (K251229) | Softac Medical Technologies | 2025-08-20 |
| Remanufactured EndoWrist Cobra Grasper (420190) (K250417) | Rebotix | 2025-08-20 |
| Remanufactured EndoWrist Tenaculum Forceps (420207) (K250539) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Long Tip Forceps (420048) (K250387) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Cadiere Forceps (420049) (K250399) | Rebotix | 2025-08-19 |
| JMS CAVEO A.V. Fistula Needle Set (K251877) | JMS North America Corporation | 2025-08-15 |
| Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K252226) | Nuwellis, Inc. | 2025-08-13 |
| KARL STORZ HOPKINS Telescopes for Urology (K243653) | Karl Storz SE & CO. KG | 2025-08-13 |
| 14F Duo-Flow® Side X Side Double Lumen Catheter (K250836) | Medical Components, Inc. | 2025-08-12 |
| UL UHD-Clear View 4K Camera System (UL-3Chip 4K) (K250462) | Univlabs Technologies Private Limited | 2025-08-11 |
| Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K252176) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-08-08 |
| Aqua Medical RF Vapor Ablation System (K251226) | Aqua Medical, Inc. | 2025-08-08 |
| Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532) (K250130) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) (K250124) | Hangzhou Viction Medical Technology Co.,Ltd | 2025-08-06 |
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |
| Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo (K251652) | American Medical Endoscopy, Inc. | 2025-08-01 |
| Forcyte Autograft Harvest Kit (K243407) | Forcyte Medical, LLC | 2025-07-29 |
| da Vinci Surgical System, IS5000 (K250442) | Intuitive Surgical, Inc. | 2025-07-29 |
| SPY Laparoscope (K252010) | Stryker Endoscopy | 2025-07-24 |
| Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580); (K243711) | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 |
| Da Vinci Surgical System (IS5000) (K251213) | Intuitive Surgical, Inc. | 2025-07-23 |
| Disposable Biopsy Needle (K244018) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 |
| Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (K243367) | Minnesota Medical Technologies | 2025-07-22 |
| InstaFAN (K251542) | Onepass Medical , Ltd. | 2025-07-18 |
| Profoject™ Enteral Feeding Syringe (K251585) | CMT Health PTE., Ltd. | 2025-07-18 |
| ARCHIMEDES Biodegradable Pancreatic Stent (K243412) | Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) | 2025-07-16 |
| Suction Valve (MAJ-1443); Air/Water Valve (MAJ-1444) (K250949) | Olympus Medical Systems Corporation | 2025-07-16 |
| da Vinci Surgical System (IS5000) (K251202) | Intuitive Surgical, Inc. | 2025-07-16 |
| Disposable Trocars (K250820) | Sinolinks Medical Innovation, Inc. | 2025-07-11 |
| Disposable Biopsy Needle (K243296) | Carbon (Shenzhen) Medical Device Co., Ltd. | 2025-07-11 |
| Marquee™ Disposable Core Biopsy Instrument and Instrument Kit (K250032) | Bard Peripheral Vascular, Inc. | 2025-07-10 |
| Single-use Ureteral Access Sheath (K250695) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-07-08 |
| Single-use Ureteral Access Sheath (K251599) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-07-03 |
| Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers (K251291) | Boston Scientific | 2025-07-03 |
| 8 mm Assist Cannula; 12 mm Assist Cannula (K251490) | Intuitive Surgical, Inc. | 2025-07-02 |
| Boehringer Laboratories Liver Retractor (K243399) | Boehringer Laboratories, LLC | 2025-07-02 |
| Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) (K250699) | Convatec | 2025-07-01 |
| Endoscopic Camera System (K250204) | Shenzhen Sophway Technology Co., Ltd. | 2025-07-01 |
| Luja Coudé (K251116) | Coloplast Corp. | 2025-06-27 |
| Maestro System (REF100) (K250984) | Moon Surgical | 2025-06-27 |
| Multi4 System (K250522) | Multi4 Medical AB | 2025-06-27 |
| Disposable Distal Cap (K243388) | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 |
| LumenaTM Ureteral Access Sheath (K250585) | Cathegenix (Xiamen) Co., Ltd. | 2025-06-27 |
| Atmo Gas Capsule System (K250940) | Atmo Biosciences, Ltd. | 2025-06-26 |
| Disposable Intermittent Catheter (TPU Catheter) (K243175) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025-06-26 |
| NeuroTrac® MyoPlus Pro (MYO120U) (K243079) | Verity Medical , Ltd. | 2025-06-26 |
| EGIS Biliary Double Bare Stent (BDB080405) (K242845) | S&G Biotech, Inc. | 2025-06-25 |
| HyperSnap Surgical System (HSS) (K250268) | Hypervision Surgical | 2025-06-24 |
| Disposable Endoscopy Valve Set (K250732) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 |
| Extracorporeal Shock Wave Lithotripter (U200) (K242922) | Shenzhen Wikkon Precision Technologies Co., Ltd. | 2025-06-18 |
| Ureteral Stents (AF-D series) (K243039) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-06-18 |
| Enteral Drainage System, Enteral Medicine straw (K242917) | HMC Premedical S.p.A. | 2025-06-18 |
| EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618) | Bridge TO Life | 2025-06-17 |
| Silicone Urethral Catheter (Silicone Urethral Catheter) (K243011) | Guangdong Ecan Medical Co., Ltd. | 2025-06-16 |
| EvoEndo Single-Use Endoscopy System (K250900) | EvoEndo, Inc. | 2025-06-16 |
| 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130) (K243237) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-06-13 |
| Vessel Sealer Curved (480522) (K250674) | Intuitive Surgical, Inc. | 2025-06-13 |
| Medical Monitor (32HS710S) (K251209) | Lg Electronics.Inc | 2025-06-12 |
| Rezum System (K250584) | Boston Scientific Corporation | 2025-06-11 |
| da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852) | Intuitive Surgical, Inc. | 2025-06-11 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (K250269) | Ambu A/S | 2025-06-11 |