| 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM (K231854) | Stryker | 2023-09-20 |
| TULSA-PRO System (K230692) | Profound Medical, Inc. | 2023-09-20 |
| Apollo ESG NXT System, Apollo REVISE NXT System (K232544) | Apollo Endosurgery, Inc. | 2023-09-18 |
| Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) (K230752) | FUJIFILM Healthcare Americas Corporation | 2023-09-15 |
| Ambu® aScope™ Colon; Ambu® aBox™ 2 (K230332) | Ambu A/S | 2023-09-15 |
| TEA Device (K230526) | Transtimulation Research, Inc. | 2023-09-14 |
| CleanCart A, CleanCart C, AK 98 Hemodialysis Machine (K232467) | Baxter Healthcare Corporation | 2023-09-14 |
| Stone Extraction Baskets (K230598) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2023-09-12 |
| FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (K223827) | Fujifilm Corporation | 2023-09-08 |
| MaxTack™ Motorized Fixation Device (K231240) | Covidien | 2023-09-08 |
| Air/Water Bottle Tubing, CO2 Source Tubing (K231471) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 |
| Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible (K230127) | Micro-Tech (Nanjing) Co., Ltd. | 2023-09-06 |
| Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) (K232314) | FUJIFILM Healthcare Americas Corporation | 2023-09-01 |
| Ancora-SB (K231323) | Aspero Medical, Inc. | 2023-08-31 |
| MedicloseTM System (K213271) | Health Value Creation B.V., Trading AS Corporis Medical | 2023-08-31 |
| EL27-Compact; Sterile EHL-Probes (K230488) | Walz Elektronik GmbH | 2023-08-31 |
| Enzyme Packed Cartridge - RELiZORB (K231156) | Alcresta Therapeutics, Inc. | 2023-08-30 |
| Precision GI (K231422) | Limaca Medical, Ltd. | 2023-08-28 |
| Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) (K230165) | Coloplast | 2023-08-25 |
| Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control (K232157) | Stryker Corporation | 2023-08-18 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) (DEN230019) | Boston Scientific Corporation | 2023-08-18 |
| Automatic Continuous Effusion Shunt (ACES) System ACES System (K231096) | Pleural Dynamics, Inc. | 2023-08-18 |
| Feeding Tube (K222773) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| Aer-O-Scope Colonoscope System (K230588) | Gi View , Ltd. | 2023-08-17 |
| Oral/Enteral Syringe with ENFit connector (K222772) | Anhui Tiankang Medical Technology Co., Ltd. | 2023-08-17 |
| AQUAbase nX (K223479) | B.Braun Medical, Inc. | 2023-08-16 |
| Revi System (DEN220073) | Bluewind Medical , Ltd. | 2023-08-16 |
| BAROguard (K223874) | Paragonix Technologies | 2023-08-15 |
| ENDOGATOR™ Hybrid Irrigation Tubing (K231418) | Medivators | 2023-08-14 |
| Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome (K232162) | Boston Scientific Corporation | 2023-08-14 |
| VersiHD with GuideMe software (K230632) | Nxstage Medical, Inc. | 2023-08-11 |
| Bladeless Trocar – Artemis Lap Cannula (K231400) | T.A.G. Medical Products Corporation, Ltd. | 2023-08-04 |
| Citric Complete Liquid Citric Acid Concentrate (K223431) | Nipro Renal Solutions USA, Corp. | 2023-08-04 |
| Disposable Ureteral Access Sheath (K230748) | Youcare Technology Co.,Ltd. (Wuhan) | 2023-08-02 |
| ActivSight Intraoperative Imaging System (K231344) | Activ Surgical, Inc. | 2023-08-02 |
| Self-Cath Closed System (K223821) | Coloplast | 2023-08-02 |
| Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing (K231602) | Ga Health Company Limited | 2023-08-01 |
| Disposable Hemoclip (K230004) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2023-07-31 |
| RenaNav Ureteroscope System (K223097) | CenterPoint Systems, LLC | 2023-07-31 |
| Blood Tubing Lines for Hemodialysis AV06C-E (K231589) | NIKKISO CO., LTD. | 2023-07-28 |
| Pathfinder Endoscope Overtube with Balloon Device (K230801) | Neptune Medical, Inc. | 2023-07-28 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249) | Pentax of America, Inc. | 2023-07-28 |
| Teleflex Rusch SoftSimplastic Foley Catheters (K212077) | Teleflexmedical, Inc. | 2023-07-27 |
| ME-APDS™; MAGENTIQ-COLO™ (K223473) | Magentiq Eye, Ltd. | 2023-07-25 |
| Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 (K231878) | STERIS Corporation | 2023-07-25 |
| EndoflipTM 300 System (K231861) | Covidien, LLC | 2023-07-21 |
| enspire 300 Series Automated Endoscope Reprocessor System (K230560) | STERIS Corporation | 2023-07-21 |
| RenaPure Endotoxin Retentive Filter (K231410) | Evoqua Water Technologies, LLC | 2023-07-19 |
| FloNavi Open Field Fluorescence Imaging System (K230407) | Guangdong Optomedic Technologies, Inc. | 2023-07-17 |
| EnteraLoc Flow (K223683) | Vonco Products | 2023-07-10 |
| ANDORATE® Valve Kit (K230932) | Ga Health Company Limited | 2023-07-07 |
| Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) (K231003) | Guangdong Optomedic Technologies, Inc. | 2023-07-06 |
| Universal Seal (5-12 mm) (K231358) | Intuitive Surgical, Inc. | 2023-07-05 |
| enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930) | STERIS Corporation | 2023-06-30 |
| ClearTip (K231267) | Finemedix Co., Ltd. | 2023-06-30 |
| PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K230991) | Given Imaging Ltd. (Medtronic) | 2023-06-30 |
| OverStitch NXT Endoscopic Suturing System (K231553) | Apollo Endosurgery, Inc. | 2023-06-29 |
| Flume Catheter (K231101) | Flume Catheter Company, Ltd. | 2023-06-29 |
| KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER- (K230359) | Karl Storz Endoscopy America, Inc. | 2023-06-23 |
| Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) (K223741) | Zhuhai Pusen Medical Technology Co., Ltd. | 2023-06-22 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K230886) | Stryker Endoscopy | 2023-06-21 |
| Tablo® Hemodialysis System (K223248) | Outset Medical, Inc. | 2023-06-21 |
| Habib EndoHPB (K231533) | Boston Scientific Corporation | 2023-06-21 |
| NAJA Gastrointestinal Catheter (K223890) | Chess Medical, Inc. | 2023-06-16 |
| OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver (K230015) | Laurane Medical Sas | 2023-06-16 |
| Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series (K230514) | NIKKISO CO., LTD. | 2023-06-16 |
| WallFlex™ Biliary RX Stent System (K223469) | Boston Scientific Corporation | 2023-06-15 |
| ClearumTM HS (K231406) | Bellco Srl | 2023-06-14 |
| Eroxon (DEN220078) | Futura Medical Developments Limited | 2023-06-09 |
| Disposable Laparoscopic Trocar (K231042) | Changzhou Ankang Medical Instruments Co., Ltd. | 2023-06-08 |
| HandX™ Self-Righting Needle Holder (K223718) | Human Xtensions , Ltd. | 2023-06-05 |
| i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727) | I3 Membrane GmbH | 2023-06-02 |
| Xpan Universal Trocar System (K223562) | Xpan, Inc. | 2023-06-02 |
| CombiSet Hemodialysis Blood Tubing Set (K213992) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-31 |
| EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) (K230909) | Cook Ireland, Ltd. | 2023-05-30 |
| Niti-S Biliary Speed D Stent (K223626) | Taewoong Medical Co., Ltd. | 2023-05-26 |
| PVC Hydrophilic Urethral Catheter (K220722) | Well Lead Medical Co., Ltd. | 2023-05-22 |
| GI Genius System 100 and GI Genius System 200 (K231143) | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 |
| Single-Use Flexible Ureteroscope (K230200) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K231224) | Intuitive Surgical, Inc. | 2023-05-12 |
| FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 (K220721) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-05-11 |
| HandX™ Monopolar Scissors (K230491) | Human Xtensions , Ltd. | 2023-05-10 |
| ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter (K220781) | Allwin Medical Devices, Inc. | 2023-05-05 |
| SimPro™ Now, GentleCath™ Hydrophilic (K223756) | Dentsply Sirona | 2023-05-04 |
| Sphincterotome (K222421) | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 |
| ASEPT Peritoneal Drainage System (K221779) | Pfm Medical, Inc. | 2023-05-02 |
| vPATCH (K223595) | Virility Medical , Ltd. | 2023-05-01 |
| Bladeless Trocar – Artemis Lap Cannula (K230058) | T.A.G. Medical Products Corporation, Ltd. | 2023-04-28 |
| Gastric Alimetry System (K223398) | Alimetry , Ltd. | 2023-04-27 |
| EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 (K222584) | Olympus Medical Systems Corporation | 2023-04-26 |
| MiVu™ Esophageal Endo Cap (K230056) | Diversatek Healthcare | 2023-04-25 |
| Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument (K223300) | Geotek Medikal Ltd Sti | 2023-04-21 |
| Flexible Video-Choledochoscope System (K222261) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-04-20 |
| EndoflipTM 300 (K223705) | Covidien, LLC | 2023-04-14 |
| NaviCam Xpress Stomach System, NaviCam Xpress System (K230694) | Anx Robotica Corp | 2023-04-13 |
| L12 LED Light Source with AIM (K230754) | Stryker | 2023-04-11 |
| SKOUT® system (K230658) | Iterative Scopes, Inc. | 2023-04-07 |
| Da Vinci SP Surgical System (SP1098) (K230033) | Intuitive Surgical, Inc. | 2023-04-05 |
| Optimos™ Cystotome (K223256) | Taewoong Medical Co., Ltd. | 2023-04-05 |
| Intermittent nelaton catheter for single use (K222677) | Hangzhou Jimushi Meditech Co., Ltd. | 2023-04-05 |