| Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018) (K233576) | Shenzhen Konmed Technology Co., Ltd. | 2024-02-23 |
| 1688 4K Camera System with Advanced Imaging Modality (K240174) | Stryker Endoscopy | 2024-02-22 |
| Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) (K232043) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024-02-16 |
| VedDilator ^TM (3-Stage Balloon Dilation Catheter) (K232245) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-15 |
| DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K240098) | STERIS Corporation | 2024-02-09 |
| Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) (K240069) | Endolumik | 2024-02-08 |
| Purema® H Hemoconcentrator (EtO Sterilized) (K232171) | Tecnoideal America | 2024-02-07 |
| 5008X Hemodialysis System (K231534) | Fresenius Medical Care | 2024-02-02 |
| CVAC Aspiration System + CVAC Image Processor (K233472) | Calyxo, Inc. | 2024-02-02 |
| Disposable Hemostatic Clips (K232450) | Zhejiang Soudon Medical Technology Co., Ltd. | 2024-01-26 |
| ViSiGi 3D Gastric Sizing Tube (K234145) | Boehringer Laboratories | 2024-01-26 |
| GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) (K232665) | Convatec | 2024-01-25 |
| 2-Way 100% Silicone Cleartract Catheter (K233013) | Silq Technologies Corporation | 2024-01-23 |
| Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector (K231299) | Cair Lgl | 2024-01-22 |
| Plenity (K230133) | Gelesis, Inc. | 2024-01-19 |
| Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes (K231166) | Zmi Electronics , Ltd. | 2024-01-18 |
| ENFit Adaptor (K233190) | Jiangsu Caina Medical Co.,Ltd | 2024-01-18 |
| NxStage PureFlow Solution (K233213) | Nxstage Medical, Inc. | 2024-01-18 |
| Arthrex Synergy Vision Endoscopic Imaging System (K233451) | Arthrex, Inc. | 2024-01-18 |
| M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle (K233031) | Canyon Medical, Inc. | 2024-01-17 |
| Video Ureteroscope System (K231135) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-01-17 |
| Uni-port (K232062) | Dalim Medical Corp. | 2024-01-16 |
| GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (K233964) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 |
| MD Mattress Suture Placement Device (K222783) | Lsi Solutions, Inc. | 2024-01-12 |
| CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital Flexible Ureteroscope (U10-B); CoralView® Single-use Digital Flexible Ureteroscope (U10-BR); CoralView® Single-use Digital Flexible Ureteroscope (U20); CoralView® Single-use Digital Flexible Ureteroscope (U20-B); CoralView® Single-use Digital Flexible Ureteroscope (U20-BR) (K231774) | MacroLux Medical Technology Co., Ltd. | 2024-01-11 |
| Disposable Hemoclip (AF series) (K231633) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-01-11 |
| 1788 4K Camera System with Advanced Imaging Modality (K233327) | Stryker Endoscopy | 2024-01-09 |
| NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether (K233229) | Anx Robotica Corporation | 2024-01-05 |
| ENDOCOLLECT Specimen Retrieval Bag (K232519) | Ximedica | 2024-01-05 |
| EndoSound Vision System; EVS (K232518) | Endosound, Inc. | 2023-12-27 |
| Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) (K233515) | Nuwellis, Inc. | 2023-12-26 |
| WellCare Anoscope (K230439) | Well Care (Wuhan) Medical Technology Co., Ltd. | 2023-12-22 |
| Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter (K232329) | Medivators (A Subsidiary of Steris Corporation) | 2023-12-21 |
| RELiZORB® (K232784) | Alcresta Therapeutics, Inc. | 2023-12-21 |
| CuratOR EX3242-FD (K231066) | Eizo Corporation | 2023-12-18 |
| AMT G-Tube Balloon Gastrostomy Feeding Device (K222846) | Applied Medical Technology, Inc. | 2023-12-18 |
| EW10-EC02 Endoscopy Support Program (K230751) | Fujifilm Corporation | 2023-12-15 |
| PhySoftAMS® (K232283) | Physician Software Systems, LLC | 2023-12-14 |
| Disposable Hot Biopsy Forceps (K231721) | Beijing Zksk Technology Co., Ltd. | 2023-12-14 |
| StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection (K233645) | Boston Scientific Corporation - | 2023-12-12 |
| NaviCam ProScan (DEN230027) | Ankon Technologies Co., Ltd. | 2023-12-12 |
| Vibrant System (K232830) | Vibrant, Ltd. | 2023-12-08 |
| 2008T BlueStar Hemodialysis Machine (K231125) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-06 |
| Tablo® Hemodialysis System (K233335) | Outset Medical, Inc. | 2023-12-05 |
| PENTAX Medical Gas/Water Feeding Valve OE-B14 (K232249) | Pentax of America, Inc. | 2023-12-01 |
| pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 |
| LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) (K232262) | Surgease Innovations Limited | 2023-11-30 |
| Disposable Endoscope Valves System (K232244) | Changzhou Endoclean Medical Device Co., Ltd. | 2023-11-29 |
| SUREcore Prime Biopsy Instrument (K230646) | Uro-1 Medical, Inc. | 2023-11-29 |
| Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (K232633) | Boston Scientific | 2023-11-28 |
| Passio Pump Drainage System (K230319) | Bearpac Medical | 2023-11-24 |
| Disposable Endoscope Valves Kit (K222499) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-11-22 |
| Endoscopy Irrigation Tubing (K230773) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 |
| KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit (K233333) | Karl Storz SE & CO. KG | 2023-11-21 |
| Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100) (K232028) | Iq Endoscopes Limited | 2023-11-17 |
| Gastric Alimetry System (K232925) | Alimetry , Ltd. | 2023-11-17 |
| Trio-CT® Triple Lumen Catheter w/ Curved Extensions (K232945) | Medical Components, Inc. (dba MedComp) | 2023-11-16 |
| Cystoscope System (K231118) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2023-11-13 |
| PRIME-XV FreezIS DMSO-Free MD (K231804) | Fujifilm Irvine Scientific | 2023-11-09 |
| Disposable Endoscope Injection Needles (K232442) | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 |
| Cure Catheter Closed System; Cure Dextra Closed System (K230400) | Convatec, Inc. | 2023-11-08 |
| da Vinci SP Surgical System (K231798) | Intuitive Surgical, Inc. | 2023-11-08 |
| Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) (K232866) | Jiangsu Channel Medical Device Co., Ltd. | 2023-11-07 |
| Disposable Sphincterotome (K232476) | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 |
| KARL STORZ ICG Imaging System (K232857) | Karl Storz SE & CO. KG | 2023-11-06 |
| GripTract-GI Endoscopic Tissue Manipulator (K231254) | Actuated Medical, Inc. | 2023-11-03 |
| Medical Video Endoscope System (K230475) | Huger Medical Instrument Co., Ltd. | 2023-11-03 |
| ENFit to ENFit Extension Sets (K230326) | Vesco Medical | 2023-11-02 |
| Inzii Ripstop Redeployable Retrieval System (K232880) | Applied Medical Resources Corporation | 2023-11-01 |
| Speedboat Flush SB1 Instrument (K230328) | Creo Medical, Ltd. | 2023-10-31 |
| Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 (K231378) | Insightec, Ltd. | 2023-10-30 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) (K233318) | Boston Scientific Corporation | 2023-10-27 |
| EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT) (K233220) | Senorx, Inc. | 2023-10-27 |
| Luja Coude (20108 Male CH18 - large packaging) (K233101) | Coloplast Corp. | 2023-10-26 |
| ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) (K233113) | Starmed Co., Ltd. | 2023-10-25 |
| Swiss LthoClast Trilogy (K230893) | E.M.S Electro Medical Systems S.A | 2023-10-23 |
| Unicare (K-UNICARE-USA) (K230983) | Tenscare, Ltd. | 2023-10-20 |
| NexPort™ Trocar System (TS211001); NexPort™ Trocar System (TS211002); NexPort™ Trocar System (TS211003); NexPort™ Trocar System (TS211010); NexPort™ Trocar System (TS211011); NexPort™ Trocar System (TS211012); NexPort™ Trocar System (TS221001); NexPort™ Trocar System (TS221002); NexPort™ Trocar System (TS221003); NexPort™ Trocar System (TS221010); NexPort™ Trocar System (TS221011); NexPort™ Trocar System (TS221012); NexPort™ Trocar System (TS221020); NexPort™ Trocar System (TS221021); (K232042) | Mediconcepts Technology (Shenzhen) Company Limited | 2023-10-20 |
| Pure-Vu EVS System (K232922) | Motus GI Medical Technologies , Ltd. | 2023-10-20 |
| BioShield Biopsy Valve (00711124); BioShield Biopsy Valve (00711125); BioShield Biopsy Valve (00711126); BioShield Biopsy Valve (00711127); BioShield Biopsy Valve (00711129); BioShield Biopsy Valve (00711135); BioShield Biopsy Valve (00711136); BioShield Biopsy Valve - sterile (00711128); BioShield Irrigator (00711133); BioShield Irrigator (00711137); BioShield Irrigating Adaptor (00711131); BioShield Irrigator - extension tubing (00711134) (K232951) | Steris | 2023-10-20 |
| Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) (K231105) | Shanghai AnQing Medical Instrument Co., Ltd. | 2023-10-17 |
| Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) (K231725) | Hunan Endoso Life Technology Co., Ltd. | 2023-10-16 |
| ANDORATE® Valve Kit (K232118) | Ga Health Company Limited | 2023-10-16 |
| Nutricair Enteral Syringe with ENFit (K231300) | Cair Lgl | 2023-10-06 |
| Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (K232046) | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023-10-06 |
| VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (K223926) | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 |
| MFG-05 (K230780) | Zimmer Medizinsysteme GmbH | 2023-10-05 |
| DuraGraft (DEN230002) | Marizyme, Inc. | 2023-10-04 |
| enspire 300 Series Automated Endoscope Reprocessor (K232918) | STERIS Corporation | 2023-10-03 |
| KARL STORZ OR1™ SCB CONTROL (WU300) (K232406) | Karl Storz SE & CO. KG | 2023-10-03 |
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (K231960) | Anx Robotica Corporation | 2023-10-03 |
| WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (K231702) | OTU Medical, Inc. | 2023-09-29 |
| REGER Nebulizer Irrigation Cannula (K231622) | Reger Medizintechnik, GmbH | 2023-09-29 |
| Guardenia (GAR-1) (K232701) | Advanced Surgical Concepts | 2023-09-29 |
| Disposable Injection Needle AF series (K230925) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2023-09-27 |
| EndoGI S-Path Biliary Stent System (K232596) | Endogi Medical, Ltd. | 2023-09-27 |
| UroLift 2 ATC Advanced Tissue Control System (K232558) | Neotract, Inc. | 2023-09-22 |
| Pelvic Floor Muscle Stimulator (K230767) | Nanjing Vishee Medical Technology Co., Ltd. | 2023-09-21 |
| EGIS Biliary Single Bare Stent (K223354) | S&G Biotech, Inc. | 2023-09-21 |
| Servator P Plus SALF Solution (K230193) | S.A.L.F. Spa | 2023-09-21 |