| KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) (K241945) | Karl Storz SE & CO. KG | 2024-08-01 |
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) (K241934) | Anx Robotica Corp | 2024-07-31 |
| EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) (K241209) | Cook Ireland, Ltd. | 2024-07-29 |
| Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056) (K241028) | Coloplast | 2024-07-26 |
| Arthrex Synergy Vision Endoscopic Imaging System (K241361) | Arthrex, Inc. | 2024-07-25 |
| KARL STORZ Fiber Telescopes for Urology (K233372) | Karl Storz SE & CO. KG | 2024-07-25 |
| GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) (K241887) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 |
| CADDIE (K240044) | Odin Medical Limited | 2024-07-24 |
| P-SCOPE (K241502) | Oui Medical, Inc. | 2024-07-24 |
| Senhance Surgical System (K233866) | Asensus Surgical, Inc. | 2024-07-19 |
| Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) (K233778) | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 |
| Endoscopic Applicator, 41 cm (K241739) | Micromedics, Inc. | 2024-07-15 |
| Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) (K241500) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-07-12 |
| HemoCare Bicarbonate Concentrate Set (BCS) (K240920) | Deka Research and Development | 2024-07-12 |
| HemoCare Hemodialysis System (K233557) | Deka Research and Development | 2024-07-12 |
| Single Use Hemoclips (K234124) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 |
| “MoFi” Cell Culture Basal Medium (K240247) | Duogenic Stemcells Corporation | 2024-07-12 |
| da Vinci SP Surgical System (SP1098) (K240502) | Intuitive Surgical, Inc. | 2024-07-08 |
| AMT Suture Passer (K241111) | Applied Medical Technology, Inc. | 2024-07-05 |
| SKOUT® system (K241508) | Iterative Scopes, Inc. | 2024-07-03 |
| Blue Eye (K241591) | The Standard Co., Ltd. | 2024-07-03 |
| VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) (K241371) | Olympus Medical Systems Corporation | 2024-07-03 |
| Disposable Enteral Feeding Sets (K240052) | Beijing L&Z Medical Technology Development Co., Ltd. | 2024-07-03 |
| Gastric Alimetry (K240946) | Alimetry , Ltd. | 2024-07-03 |
| da Vinci Surgical System (IS5000) (K241284) | Intuitive Surgical, Inc. | 2024-07-03 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500) (K241598) | Boston Scientific Corporation | 2024-07-01 |
| StarFormer (K234061) | Fotona D.O.O. | 2024-07-01 |
| Single-use Video Ureterorenoscope (SVU-220US) (K241639) | Huger Medical Instrument Co., Ltd. | 2024-07-01 |
| NovaLine SP-C35 Transducer Protector (956007) (K240164) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 |
| Pathfinder® CR System (K240853) | Neptune Medical, Inc. | 2024-06-27 |
| Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) (K233840) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-26 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 (K233630) | Ambu A/S | 2024-06-24 |
| GERDX-System (K233240) | G-Surg GmbH | 2024-06-21 |
| Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) (K240663) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-06-21 |
| SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) (K233225) | Schoelly Fiberoptic GmbH | 2024-06-20 |
| EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 (K232997) | Olympus Medical Systems Corporation | 2024-06-19 |
| Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) (K240196) | Yuwonmeditech Co., Ltd. | 2024-06-18 |
| Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM (K233294) | Itp Innovative Tomography Products GmbH | 2024-06-18 |
| Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) (K233079) | Cook Ireland, Ltd. | 2024-06-14 |
| Double Balloon Endoscope EN-840T, Over-tube TS-1214C (K233321) | FUJIFILM Healthcare Americas Corporation | 2024-06-13 |
| 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) (K233892) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-13 |
| AquaBplus; AquaB LITE (K232953) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-06-13 |
| PLASMA EDGE System (K240504) | Lamidey Noury Medical | 2024-06-12 |
| BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) (K240283) | MacroLux Medical Technology Co., Ltd. | 2024-06-10 |
| KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) (K232911) | Karl Storz Endovision, Inc. | 2024-06-10 |
| Uro-G HD Flexible Cystoscope (K232837) | Uroviu Corporation | 2024-06-07 |
| Disposable Hemostatic Clips (K232969) | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 |
| CORTRAK* 2 Enteral Access System (20-0950) (K240965) | Avanos Medical, Inc. | 2024-06-06 |
| Wellead® Latex Foley Catheter (K233094) | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| da Vinci SP Surgical System (SP1098) (K232773) | Intuitive Surgical, Inc. | 2024-06-04 |
| 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) (K240617) | Olympus Medical Systems Corp. | 2024-06-03 |
| Stylus (K233591) | Degania Silicone , Ltd. | 2024-05-31 |
| multiFlux 1000 (F00012408) (K240394) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 |
| Monik™ - Disposable Endoscopic Trocar (K233386) | M/s. Meril Endo Surgery Private Limited. | 2024-05-24 |
| da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200) (K240723) | Intuitive Surgical | 2024-05-24 |
| troCarWash™ System (K233442) | Biotex, Inc. | 2024-05-21 |
| ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B-2017); Gastric Balloon Suction Catheter (B-2020) (K241039) | Reshape Lifesciences | 2024-05-16 |
| Ureterorenoscope System (K240374) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-05-10 |
| pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070) (K233950) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-10 |
| PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software (K240276) | Given Imaging Ltd. (D.B.A. Medtronic) | 2024-05-10 |
| Tulsa Pro System (Pad-105) (K240296) | Profound Medical, Inc. | 2024-05-09 |
| KARL STORZ Monopolar Resectoscopes with HF Cable (K232486) | Karl Storz SE & CO. KG | 2024-05-07 |
| Solar Compact (G4-1) (K240007) | Laborie Medical Technologies, Corp. | 2024-05-06 |
| ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (K234033) | Boehringer Laboratories, LLC | 2024-05-06 |
| Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized) (K233524) | Hollister Incorporated | 2024-05-03 |
| Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer (K232776) | Outset Medical, Inc. | 2024-05-03 |
| Revi™ System (K240037) | Bluewind Medical , Ltd. | 2024-05-02 |
| Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps (K233752) | CenterPoint Systems, LLC | 2024-05-02 |
| DuraGraft Vascular Conduit Solution (K240925) | Marizyme | 2024-05-01 |
| Percutaneous Nephroscope System (K232370) | Karl Storz SE & CO. KG | 2024-05-01 |
| EsophyX Z+ Device with SerosaFuse Fasteners and Accessories (K240879) | Endogastric Solutions, Inc. | 2024-04-26 |
| ENDOFIX EXO (K232405) | Aktormed GmbH | 2024-04-25 |
| Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) (K234107) | Laborie Medical Technologies, Corp. | 2024-04-23 |
| SKOUT® system (K240781) | Iterative Scopes, Inc. | 2024-04-19 |
| Enteral Feeding Sets (K240039) | Hangzhou Primecare Medical Co., Ltd. | 2024-04-17 |
| TraumaGuard Intra-abdominal Pressure Sensing System (K240057) | Sentinel Medical Technologies, LLC | 2024-04-17 |
| Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 (K233886) | Ambu A/S | 2024-04-16 |
| Ez Catch Auto; Ez Catch YR; Ez Catch TR (K240205) | Veol Medical Technologies Pvt , Ltd. | 2024-04-15 |
| Folysil Silicone Catheter (K233411) | Coloplast Corp. | 2024-04-15 |
| Mobility+ Enteral Feeding System OTC (K233034) | Rockfield Medical | 2024-04-12 |
| Disposable Injection Needles (K232200) | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-04-12 |
| Disposable Trocars (K233263) | Hangzhou Kangji Medical Instrument Co., Ltd. | 2024-04-09 |
| Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (K232919) | Ambu A/S | 2024-04-05 |
| ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm (K240635) | Ximedica | 2024-04-01 |
| Disposable Sphincterotome (K232825) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 |
| RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) (K233275) | Gyrus Acmi, Inc. | 2024-03-25 |
| RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (K232920) | Ureteral Stent Company | 2024-03-22 |
| Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector (K232067) | Medivators (A Subsidiary of Steris Corporation) | 2024-03-22 |
| Disposable Dual Action Tissue Closure Device (K233772) | Mirco-Tech (Nanjing) Co., Ltd. | 2024-03-19 |
| Endorail (K232327) | Endostart S.R.L. | 2024-03-15 |
| NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) (K232803) | Nxstage Medical, Inc. | 2024-03-14 |
| da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610) | Intuitive Surgical, Inc. | 2024-03-14 |
| MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 (K231849) | Baxter Healthcare | 2024-03-12 |
| Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) (K232826) | Steris | 2024-03-08 |
| Ultrasonic Gastrovideoscope (K231813) | Sonoscape Medical Corp. | 2024-03-08 |
| Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector (K232004) | Medivators (A Subsidiary of Steris Corporation) | 2024-03-06 |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes (K240352) | STERIS Corporation | 2024-03-06 |
| Choledochoscope System (K231497) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024-03-06 |
| Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) (K232752) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-26 |
| GOLFF Sterile Anti-Fog Solution (K231822) | Batrik Medical Manufacturing, Inc. | 2024-02-26 |