| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K243512) | Fujifilm Corporation | 2025-06-10 |
| SpydrBlade Flex Instrument (PRD-RG1-001) (K242774) | Creo Medical, Ltd. | 2025-06-06 |
| KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (K243550) | Karl Storz SE & CO. KG | 2025-06-06 |
| Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891) | Convatec Limited | 2025-06-06 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (K250701) | Olympus Medical Systems Corp. | 2025-06-05 |
| PENTAX Medical Video Processor (EPK-i8020c) (K251127) | Pentax of America, Inc. | 2025-06-03 |
| CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (K250452) | MacroLux Medical Technology Co., Ltd. | 2025-06-02 |
| 5008X Hemodialysis System (K243505) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-05-30 |
| Endoscopic Distal Attachment (AF-D series) (K242635) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2025-05-30 |
| Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) (K242699) | Opcom Medical, Inc. | 2025-05-28 |
| Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q; Single Use 2-Lumen Cannula V PR-V614M (K250573) | Olympus Medical Systems Corp. | 2025-05-27 |
| FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L (K243261) | Fujifilm Corporation | 2025-05-23 |
| Optilume® High Pressure Urological Balloon Dilation Catheter (K250910) | Urotronic, Inc. | 2025-05-22 |
| ArgoCap (200.52) (K242586) | Ovesco Endoscopy AG | 2025-05-22 |
| ClearHemograsper (K242857) | Finemedix Co., Ltd. | 2025-05-21 |
| MotiliCap GI Monitoring System (K250493) | Anx Robotica Corporation | 2025-05-21 |
| Byonyks X-1 APD Cycler; Byonyks Automated PD Set DS-1 (K243371) | Byonyks Pvt, Ltd. | 2025-05-16 |
| Hemodialysis Catheter (K241581) | Haolang Medical USA Corporation | 2025-05-16 |
| DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (K242155) | NIKKISO CO., LTD. | 2025-05-15 |
| Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal Videoscope (GIF-EZ1500) (K250432) | Olympus Medical Systems Corporation | 2025-05-15 |
| NeurAxis IB-Stim (01-1020) (K250451) | Neuraxis | 2025-05-15 |
| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) (K242176) | NIKKISO CO., LTD. | 2025-05-15 |
| BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU (K242479) | NIKKISO CO., LTD. | 2025-05-15 |
| Disposable ureteral stent (K243830) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-05-14 |
| SP Endoscope, 0° (430600) (K250786) | Intuitive Surgical, Inc. | 2025-05-13 |
| SKOUT system (K251126) | Iterative Health | 2025-05-09 |
| Single-use Flexible Ureteroscope (K250785) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 |
| ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (K240447) | Thermasolutions, LLC | 2025-05-05 |
| Arthrex Synergy Vision Endoscopic Imaging System (K250728) | Arthrex, Inc. | 2025-05-05 |
| F88 URE-SD/RD Flexible Ureteroscope (K243894) | Sg Endoscopy Pte, Ltd. | 2025-05-02 |
| KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (K244001) | Karl Storz SE & CO. KG | 2025-05-02 |
| Disposable Distal Attachment D-201 Series (K250296) | Olympus Medical Systems Corp. | 2025-05-01 |
| X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870) | Traferox Technologies, Inc. | 2025-05-01 |
| PUMA-G Pediatric System (K242211) | Coaptech, Inc. | 2025-04-29 |
| ExpressCore Biopsy Device (K243886) | Inrad, Inc. | 2025-04-29 |
| LumiRex Ureteroscope (K243532) | Contra Healthcare Solutions, LLC | 2025-04-28 |
| DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) (K243264) | Sorin Group Italia S.R.L. | 2025-04-25 |
| DCX Disposable Cassette (DCX) (K243998) | Institut Geroges Lopez | 2025-04-25 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K243945) | SurGenTec, LLC | 2025-04-24 |
| da Vinci SP Surgical System (SP1098) (K243714) | Intuitive Surgical, Inc. | 2025-04-24 |
| Extension Feeding Set with ENFit™ Connectors (K250481) | SKY Medical, a.s. | 2025-04-18 |
| PADLOCK CLIP EFTR Kit (00713229) (K250842) | STERIS Corporation | 2025-04-18 |
| RELiZORB (100300/100301) (K250499) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| Luja Set (K250270) | Coloplast Corp. | 2025-04-17 |
| SimpleStitch Suturing System (K243750) | Envision Endoscopy | 2025-04-17 |
| Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set (K250824) | Boston Scientific Corporation | 2025-04-15 |
| FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R (K243260) | Fujifilm Corporation | 2025-04-11 |
| Disposable ureteral access sheath (K243710) | Shenzhen Trious Medical Technology Co., Ltd. | 2025-04-11 |
| Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) (K243857) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025-04-11 |
| Chlorine Sentinel II (K243898) | Nelson Environmental Technologies, Inc. | 2025-04-11 |
| XNY Disposable Gastric Calibration Tube (K250389) | Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd | 2025-04-10 |
| Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G) (K243786) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-04 |
| stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch (K250404) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-04-03 |
| VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA (K242067) | Olympus Corporations of the Americas | 2025-04-02 |
| da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K242427) | Intuitive Surgical, Inc. | 2025-04-01 |
| Belzer UW® Cold Storage Solution (BTLBUW-001) (K243384) | Bridge TO Life | 2025-03-31 |
| Flexi-Seal AIR (with ENFit Connector) (K243228) | Convatec | 2025-03-28 |
| Levina Pelvic Floor Muscle Stimulator (RS-48) (K241862) | Zmi Electronics , Ltd. | 2025-03-27 |
| Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) (K243708) | Scivita Medical Technology Co., Ltd. | 2025-03-27 |
| Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) (K243840) | Bridge TO Life | 2025-03-26 |
| SB Knife Jr2 (MD-47702 and MD-47702L) (K241855) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 |
| 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)) (K243052) | Bright Uro, Inc. | 2025-03-24 |
| Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006 (K250517) | Boston Scientific Corporation | 2025-03-21 |
| EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS) (K243032) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| Electrohydraulic Lithotriptor (TCS-B3-II) (K242888) | Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. | 2025-03-21 |
| FX CorAL 40 (F00009214); FX CorAL 50 (F00009215) (K242053) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-03-21 |
| Endoscopic Water Pump (K241704) | Hangzhou AGS MedTech Co., Ltd. | 2025-03-20 |
| Luer-Split MAJ-2092 (K241842) | Olympus Medical Systems Corporation | 2025-03-19 |
| Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P (K243807) | Olympus Medical Systems Corp. | 2025-03-18 |
| UPT Series Medical RO Water Treatment System (K250514) | Specialty Water Technologies, Inc. | 2025-03-17 |
| LAGIS Suction Irrigation System (K243867) | Lagis Enterprise Co., Ltd. | 2025-03-17 |
| Maestro System (REF100) (K242323) | Moon Surgical | 2025-03-14 |
| DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System (K250411) | Dannik, LLC | 2025-03-12 |
| 8mm Monopolar Curved Scissors (470179) (K242610) | Iconocare Health | 2025-03-11 |
| Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) (K243535) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2025-03-07 |
| Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (K241734) | Well Lead Medical Co., Ltd. | 2025-03-05 |
| da Vinci SP Advanced Access Port Kit (432701) (K243582) | Intuitive Surgical, Inc. | 2025-02-28 |
| FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975) (K243874) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-02-28 |
| Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) (K242128) | Xaga Surgical | 2025-02-27 |
| EzVu Visual Vasopressor injector (EV-19) (K241595) | Veol Medical Technologies Pvt , Ltd. | 2025-02-27 |
| Defendo Fujifilm 700 Single Use Cleaning Adapter (K250140) | Steris Corparation | 2025-02-20 |
| OPTOVISION Endoscopic Light Source Unit (K243591) | Optosurgical, LLC | 2025-02-19 |
| Fecobionics Anorectal System (K242666) | Gi Bionics, LLC | 2025-02-12 |
| MOR (K241897) | Morari, Inc. | 2025-02-11 |
| Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) (K243155) | Dongguan Zsr Biomedical Technology Company Limited | 2025-02-11 |
| BTL-398 (K241516) | BTL Industries, Inc. | 2025-02-10 |
| Endoscopic Video Image Processor (RP-IPD-V1000F) (K243321) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-02-07 |
| Disposable Sphincterotome (K242192) | Beijing Zksk Technology Co., Ltd. | 2025-02-06 |
| Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612) (K250066) | Boston Scientific Corporation | 2025-02-06 |
| Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 (K243820) | Dornier Medtech America | 2025-01-31 |
| Ureteral Access Sheath (K243025) | Seplou (Zhuhai) Co., Ltd. | 2025-01-30 |
| Digital Video Processor (K243117) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-01-29 |
| Medical Monitor (27HS714S) (K243439) | Lg Electronics.Inc | 2025-01-28 |
| OrganProtex HTK Solution (K241239) | Bridge TO Life, Ltd. | 2025-01-24 |
| MAGENTIQ-COLO (ME-APDS) (K244023) | Magentiq Eye, Ltd. | 2025-01-24 |
| Bone Marrow Biopsy Needle (K242322) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle (K241793) | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 |
| Arthrex NanoScope System (K243008) | Arthrex, Inc. | 2025-01-22 |
| Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) (K241956) | Hunan Endoso Life Technology Co., Ltd. | 2025-01-22 |
| Biliary Pancreaticobiliary Scope System (K241444) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2025-01-21 |