| Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (K243568) | Wilson-Cook Medical, Inc. | 2025-01-17 |
| hygh-tec Drainage II (K242336) | Amb Medtec | 2025-01-17 |
| RELiZORB (100300/ 100301) (K243284) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| ASEPT® Glide Peritoneal Drainage System (K241278) | Pfm Medical, Inc. | 2025-01-14 |
| ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (K242901) | Tools For Surgery, LLC | 2025-01-10 |
| Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (K242228) | Triopsy Medical, Inc. | 2025-01-10 |
| PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110) | Pentax of America, Inc. | 2025-01-03 |
| Haemostasis Clips (K241005) | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | 2025-01-02 |
| Single-use Balloon Dilatation Catheter (K241888) | Leo Medical Co., Ltd. | 2024-12-20 |
| SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230) (K242923) | Envision Endoscopy | 2024-12-20 |
| Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (K243607) | Diality, Inc. | 2024-12-20 |
| Nutrifit (K243361) | Vygon USA | 2024-12-19 |
| System 83 Revolve Endoscope Washer/Disinfector (K241168) | Wassenburg Medical, Inc. | 2024-12-19 |
| Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE) (K243652) | Cardinalhealth | 2024-12-19 |
| Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2) (K242535) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-12-18 |
| Tornus ES (K241801) | Asahi Intecc Co., Ltd. | 2024-12-17 |
| da Vinci Surgical System (IS5000) (K243641) | Intuitive Surgical, Inc. | 2024-12-16 |
| Extraction Basket (K243471) | Micro-Tech (Nanjing) Co., Ltd. | 2024-12-16 |
| Uro-G HD Cystoscope (1520) (K243196) | Uroviu Corporation | 2024-12-13 |
| LCD Monitor (MDEC-2523) (K243307) | Barco N.V. | 2024-12-13 |
| Gastro Concepts Air Assist (K242668) | Gastro Concepts, LLC | 2024-12-13 |
| Aqua Medical RF Vapor Ablation System (K241271) | Aqua Medical, Inc. | 2024-12-12 |
| RED (K242304) | Neuraxis, Inc. | 2024-12-06 |
| PeritX™ 1L Drainage Kit (90-1010); PeritX™ 2L Drainage Kit (90-2010); PeritX™ Peritoneal Catheter Kit (50-9000C); PeritX™ Peritoneal Catheter and Starter Kit (50-9900C); PeritX™ Peritoneal Catheter Mini Kit (50-9050A); PleurX™ Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX™ Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX™ Supplemental Insertion Kit (50-7262); Procedure Pack (50- (K241946) | Bard Peripheral Vascular, Inc. | 2024-12-06 |
| WallFlex Biliary PLUS RX Stent System (K242950) | Boston Scientific | 2024-12-06 |
| PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (K241213) | Pentax of America, Inc. | 2024-12-06 |
| CapsoCam Plus (SV-3) Capsule Endoscopy System (K242643) | CapsoVision, Inc. | 2024-12-04 |
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433) | STERIS Corporation | 2024-12-02 |
| Pelvic Floor Stimulator (Intrelief PFE) (K241899) | Easymed Instruments Co., Ltd. | 2024-11-27 |
| KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) (K243409) | Karl Storz SE & CO. KG | 2024-11-27 |
| da Vinci SP Surgical System (SP1098) (K242318) | Intuitive Surgical, Inc. | 2024-11-26 |
| SureCath Set (K242049) | Coloplast Corp. | 2024-11-26 |
| LungProtect (K240650) | Traferox Technologies, Inc. | 2024-11-26 |
| Entarik NI Feeding Tube System (K241169) | Gravitas Medical, Inc. | 2024-11-22 |
| Suction Irrigation Tubing Set (K242927) | Advamedix, GmbH | 2024-11-22 |
| Luja Coude (K241210) | Coloplast Corp. | 2024-11-21 |
| da Vinci SP Instruments (SP1098) (K241814) | Intuitive Surgical, Inc. | 2024-11-18 |
| Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (K242173) | Coloplast Corp. | 2024-11-12 |
| Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) (K243075) | STERIS Corporation | 2024-11-08 |
| Remanufactured EndoWrist ProGrasp Forceps (420093) (K241872) | Rebotix | 2024-11-07 |
| MultiCut Solo (K240831) | Asclepion Laser Technologies GmbH | 2024-11-06 |
| SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651) (K242269) | Quanta Dialysis Technologies, Ltd. | 2024-11-01 |
| Over-tube (TR-1108A) (K243091) | Fujifilm Corporation | 2024-11-01 |
| AMT Low-Profile Suprapubic Catheter & Drainage Set (K240514) | Applied Medical Technology, Inc. | 2024-11-01 |
| Stone Clear (SC-LP9-01) (DEN230082) | Sonomotion, Inc. | 2024-10-30 |
| MedicCO2LON (MedicCO2LON) (K240847) | Ide Vision, Ltd. | 2024-10-30 |
| NeurAxis IB-Stim (01-1020) (K241533) | Neuraxis | 2024-10-30 |
| LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) (K240334) | Lagis Enterprise Co., Ltd. | 2024-10-30 |
| Mammotome AutoCore™ Single Insertion Core Biopsy System (K243095) | Devicor Medical Products, Inc. | 2024-10-29 |
| CORGRIP* SR NG/NI Tube Retention System (K241185) | Avanos Medical, Inc. | 2024-10-25 |
| FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (K242513) | Guangdong Optomedic Technologies, Inc. | 2024-10-23 |
| KIDNEYvault Portable Renal Perfusion System (K234060) | Paragonix Technologies | 2024-10-23 |
| Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 |
| KARL STORZ Holders (K240506) | Karl Storz Endoscopy America, Inc. | 2024-10-22 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 (K240849) | Ambu A/S | 2024-10-16 |
| Single-use Extraction Baskets (K240192) | Scivita Medical Technology Co., Ltd. | 2024-10-15 |
| Hood (DH-083ST) (K242779) | Fujifilm Corporation | 2024-10-11 |
| DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) (K242742) | STERIS Corporation | 2024-10-11 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aView™ 2 Advance (K240848) | Ambu A/S | 2024-10-10 |
| TRAP EASY (K242029) | H.S Hospital Service S.P.A | 2024-10-09 |
| Single-use Ureteral Access Sheath (K240167) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-08 |
| Water Container (MAJ-901); Water Container (MAJ-902) (K242357) | Olympus Medical Systems Corporation | 2024-10-07 |
| Bladeless Trocar; Bladed Trocar; Hasson Trocar (K241052) | Advamedix, GmbH | 2024-10-04 |
| Video Ureteroscope System (K241434) | Hunan Vathin Medical Instrument Co., Ltd. | 2024-10-04 |
| GripTract-GI Endoscopic Tissue Manipulator Lower GI Models (K242325) | Actuated Medical, Inc. | 2024-10-04 |
| Endoscopic Injection Needles (K240675) | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 |
| Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) (K240074) | Shenzhen Besdata Technology Co., Ltd. | 2024-10-04 |
| TroCare TroKit Laparoscope Lens Wiper (CP000626) (K241796) | TroCare, LLC | 2024-10-04 |
| Disposable Endoscope Valves Set (AF series) (K241285) | Alton (Shanghai) Medical Instruments Co., Ltd. | 2024-10-01 |
| Aspiration Catheter (2189) (K241874) | Hobbs Medical, Inc. | 2024-09-24 |
| InnoCare Specialty Foley Catheter (K241424) | Innocare Urologics, LLC | 2024-09-18 |
| PADLOCK CLIP EFTR Kit (00713229) (K240274) | STERIS Corporation | 2024-09-17 |
| Epitomee (K240544) | Epitomee Medical , Ltd. | 2024-09-13 |
| 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads (K241638) | Intuitive Surgical, Inc. | 2024-09-10 |
| MSC SFM (K232543) | Yocon Biology Technology Company | 2024-09-06 |
| Mucosal Impedance Measurement System (K233974) | Alandra Medical Sapi DE CV | 2024-09-06 |
| URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) (K240203) | Dyne Medical Group, Inc. | 2024-09-05 |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K240142) | Fujifilm Corporation | 2024-09-04 |
| WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV (K240464) | Boston Scientific | 2024-08-30 |
| da Vinci Handheld Camera (K241913) | Intuitive Surgical Operations, Inc. | 2024-08-28 |
| injeTAK Adjustable Tip Needle (DIS199; DIS201) (K241523) | Laborie Medical Technologies, Corp. | 2024-08-27 |
| BARS Set (100.60) (K241858) | Ovesco Endoscopy AG | 2024-08-26 |
| LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) (K240227) | Lina Medical Aps | 2024-08-22 |
| ClearCap Distal Attachment (K242134) | Finemedix Co., Ltd. | 2024-08-20 |
| Histolog® Scanner (Hardware 2.4, Software 3.3) (K241275) | Samantree Medical SA | 2024-08-19 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance (K242108) | Ambu A/S | 2024-08-16 |
| Avicenna Roboflex (K233700) | Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi | 2024-08-16 |
| Reusable Interface Cable 1.5 m (PRD-IFC-002) (K242061) | Creo Medical, Ltd. | 2024-08-15 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K241401) | Stryker Endoscopy | 2024-08-15 |
| Medical Monitor (32HR734S) (K241402) | Lg Electronics.Inc | 2024-08-12 |
| ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (K240664) | SurGenTec, LLC | 2024-08-09 |
| SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499); ARTip solo (202426) + ARTip solo voice (202445); SOLOASSIST II (141364) + VOICE CONTROL (171894 (K233312) | Aktormed GmbH | 2024-08-08 |
| Stellar Imaging System (K241530) | Guangdong Optomedic Technologies, Inc. | 2024-08-07 |
| Universal Seal (5-12 mm) (K241360) | Intuitive Surgical, Inc. | 2024-08-05 |
| Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00) (K233653) | Peregrine Surgical, LLC | 2024-08-05 |
| Moda-flx Hemodialysis System and Cartridge (K233798) | Diality, Inc. | 2024-08-02 |
| Disposable Ureteral Guide Sheath (K241181) | Dongguan Zsr Biomedical Technology Company Limited | 2024-08-02 |
| Rüsch Latex Gold Foley Catheter (K232469) | Teleflexmedical, Inc. | 2024-08-01 |
| PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 ) (K233942) | Pentax of America, Inc. | 2024-08-01 |