| GUARDIAN™ Quick Dip Residual Chlorine (5212) (K253863) | Serim Research | 2026-03-17 |
| BARE Wireguided Balloon Dilation Catheter (1235) (K253987) | GIE Medical | 2026-03-13 |
| Niti-S SPAXUS Stent (K252648) | Taewoong Medical Co., Ltd. | 2026-03-13 |
| Deep Capsule® (Deep Capsule US) (K250655) | Digestaid - Artificial Intelligence Development SA | 2026-03-12 |
| Urocross Expander System (Model Numbers ES2018 and ES3025) (K253525) | Prodeon Medical, Inc. | 2026-03-12 |
| Taurus Clip (K253734) | Taurus Endoscopy | 2026-03-12 |
| Liv Pre-lubricated Intermittent Catheter (K260502) | HR Healthcare | 2026-03-12 |
| da Vinci Force Feedback Instruments (K253986) | Intuitive Surgical, Inc. | 2026-03-11 |
| FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000 (K251861) | Fujifilm Corporation | 2026-03-09 |
| Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR (K251807) | Olympus Medical Systems Corp. | 2026-03-06 |
| CVAC Image Processor (K260013) | Calyxo, Inc. | 2026-03-06 |
| Single use stone retrieval balloons (K253132) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 |
| Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char (K260365) | Devicor Medical Products, Inc. | 2026-03-04 |
| C-Lant Port (K252714) | Vigor Medical Technologies , Ltd. | 2026-02-27 |
| KARL STORZ ICG Imaging System with RUBINA® Lens (K254242) | Karl Storz SE & CO. KG | 2026-02-26 |
| Universal Seal (5-12 mm) (K253978) | Intuitive Surgical, Inc. | 2026-02-24 |
| Rubber Utility Catheter (K251864) | C.R. Bard, Inc. | 2026-02-23 |
| ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial (K252795) | Argon Medical Devices, Inc. | 2026-02-23 |
| Single Use Distal Cover MAJ-2315 (MAJ-2315) (K253646) | Olympus Medical Systems Corp. | 2026-02-22 |
| Advanced Tissue Resection Device (K251692) | Micro-Tech (Nanjing) Co., Ltd. | 2026-02-21 |
| Disposable Ureteral Stents (K251890) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 |
| 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (K260185) | Stryker Endoscopy | 2026-02-18 |
| FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (K250550) | Fujifilm Corporation | 2026-02-17 |
| cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (K251852) | VPIX Medical, Inc. | 2026-02-13 |
| Endomina EZFuse system (K252400) | Endo Tools Therapeutics S.A. | 2026-02-13 |
| Well-Life Incontinence Stimulation System (WL-2405i(P)) (K251760) | Well-Life Healthcare , Ltd. | 2026-02-12 |
| Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (K260177) | Xenocor, Inc. | 2026-02-12 |
| IMAGE1 (TC400US); X-to-4U Adapter (TC040) (K253972) | Karl Storz SE & CO. KG | 2026-02-12 |
| L12 LED Light Source with AIM (K260108) | Stryker Endoscopy | 2026-02-12 |
| multiFlux 130 (F00013123); multiFlux 160 (F00013124) (K252459) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-02-10 |
| Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR (K253568) | Fujifilm Corporation | 2026-02-06 |
| Disposable Distal End Tape Hood (K252457) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2026-01-30 |
| BAROguard Donor Lung Preservation System (K254305) | Paragonix Technologies, Inc. | 2026-01-30 |
| EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter Kits (K251274) | HR Healthcare | 2026-01-29 |
| Medical Shaver System (Morcellator) (YSB-IIIA) (K251923) | Hangzhou Hawk Optical Electronic Instruments Co., Ltd. | 2026-01-29 |
| NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) (K253462) | Fresenius Medical Care Renal Therapies Group, LLC | 2026-01-29 |
| Vena MicroAngioscope™ System (K253842) | Vena Medical Holdings Corp | 2026-01-28 |
| Tablo Hemodialysis System (PN-0008000, PN-0006000U) (K253412) | Outset Medical, Inc. | 2026-01-26 |
| Elitone for Men (K253285) | Elidah, Inc. | 2026-01-23 |
| Pneumo Dissector Hook (K252957) | Ab Medica Sas | 2026-01-23 |
| Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G; Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D) (K251338) | Scivita Medical Technology Co., Ltd. | 2026-01-20 |
| Rusch SoftSimplastic Foley Catheters (K252537) | Teleflex Medical Sdn. Bhd. | 2026-01-20 |
| da Vinci Surgical System (IS5000) (K251739) | Intuitive Surgical, Inc. | 2026-01-16 |
| da Vinci SP Surgical System (SP1098); da Vinci E-200 Generator (K253556) | Intuitive Surgical, Inc. | 2026-01-16 |
| VITAL Tubing Sets for Hemodialysis (K251341) | Vital Healthcare Sdn. Bhd. | 2026-01-16 |
| VitaSmart Hypothermic Oxygenated Perfusion System (DEN250009) | Bridge TO Life, Ltd. | 2026-01-15 |
| Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control (K254014) | Stryker Endoscopy | 2026-01-13 |
| Break Wave (K252913) | Sonomotion, Inc. | 2026-01-12 |
| Ready to use Nelaton Catheter (K251178) | Jamjoom Fullcare Corporation | 2026-01-02 |
| Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (K251123) | Taewoong Medical Co., Ltd. | 2025-12-29 |
| BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (K251019) | Bioteque Corporation | 2025-12-22 |
| SKOUT system (K253664) | Iterative Health | 2025-12-22 |
| Endura™ Ureteral Stent and Stent Set (K251469) | Cathegenix (Xiamen) Co., Ltd. | 2025-12-19 |
| CE Deliver (DLV) (K252480) | CapsoVision, Inc. | 2025-12-19 |
| OTSCneo System Set (100.03n-14n, 100.27n-31n) (K251562) | Ovesco Endoscopy AG | 2025-12-18 |
| Single Use Cytology Brush V (BC-V600P-3010) (K250993) | Olympus Medical Systems Corporation | 2025-12-18 |
| FX CorAL 40; FX CorAL 50 (K253518) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-12-18 |
| Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Digital Flexible Ureteroscope (GY-UR7.5); Endoscope camera system (GY-AIO-121) (K252468) | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025-12-16 |
| Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Processor (RP-IPD-V2000EF); Endoscopic Video Image Processor (RP-IPD-V1000F) (K251951) | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025-12-16 |
| PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (K251256) | Pentax of America, Inc. | 2025-12-16 |
| da Vinci SP Surgical System (SP1098) (K252675) | Intuitive Surgical, Inc. | 2025-12-15 |
| EnCor EnCompass™ Breast Biopsy and Tissue Removal System (K252681) | Bard Peripheral Vascular, Inc. | 2025-12-12 |
| Revi System (K252391) | Bluewind Medical , Ltd. | 2025-12-12 |
| Gastric Alimetry (K252504) | Alimetry , Ltd. | 2025-12-05 |
| Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) (K251403) | Dornier Medtech America Inc (Dmta) | 2025-12-05 |
| mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) (K252605) | Medspira, LLC | 2025-12-05 |
| da Vinci SP Surgical System (SP1098) (K252069) | Intuitive Surgical, Inc. | 2025-12-02 |
| Disposable Endoscopic Injection Needles (K252021) | Changzhou New Med Micro-Medtech Co., Ltd. | 2025-12-02 |
| Vanquish Water Vapor Ablation Device (K252388) | Francis Medical, Inc. | 2025-11-26 |
| Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (K252889) | Olympus Medical Systems Corporation | 2025-11-25 |
| KARL STORZ Cholangiography Set (K250927) | Karl Storz SE & CO. KG | 2025-11-22 |
| Nuvis® Wireless HD Camera System (Nuvis-2K) (K242606) | Integrated Endoscopy, Inc. | 2025-11-20 |
| Focal One® (K251910) | Edap Technomed, Inc. | 2025-11-19 |
| Miniature Telescope for Urology (27033AA) (K253411) | Karl Storz SE & CO. KG | 2025-11-18 |
| AquaC UNO H (K250471) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| Hemoclip (K252271) | Hangzhou AGS MedTech Co., Ltd. | 2025-11-12 |
| VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700); VISERA ELITE III Light Source Olympus CLL-S700 (CLL-S700); 4K Camera Head Olympus CH-S700-XZ-EA (CH-S700-XZ-EA) (K251336) | Olympus Medical Systems Corp. | 2025-11-12 |
| Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (K250917) | Shenzhen Sanping Image Technology Co., Ltd. | 2025-10-31 |
| Kii Structural Balloon Access System (K252442) | Applied Medical Resources Corp. | 2025-10-31 |
| GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (K251041) | Actuated Medical, Inc. | 2025-10-31 |
| 3D Laparoscope (K252697) | Guangdong Optomedic Technologies, Inc. | 2025-10-29 |
| Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) (K252646) | Olympus Medical Systems Corp. | 2025-10-24 |
| UV5000W Handle (K253226) | Uroviu Corporation | 2025-10-23 |
| Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA) (K250409) | Olympus Medical Systems Corporation | 2025-10-21 |
| VereSee Optical Veres Needle and Endoscopic Camera (K252640) | Freyja Healthcare, LLC | 2025-10-20 |
| Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) (K250945) | Olympus Medical Systems Corp. | 2025-10-17 |
| Modius Lean (DEN240076) | Neurovalens Limited | 2025-10-17 |
| Biopsy Port Adapter (K250145) | Endosound, Inc. | 2025-10-17 |
| NeurAxis IB-Stim (01-1020) (K252024) | Neuraxis | 2025-10-16 |
| Arthrex Synergy Vision Imaging System (K251994) | Arthrex, Inc. | 2025-10-16 |
| Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L) (K252247) | Olympus Medical Systems Corporation | 2025-10-16 |
| Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351) | Olympus Medical Systems Corporation | 2025-10-10 |
| EvoEndo Single-Use Endoscopy System (K251708) | EvoEndo, Inc. | 2025-10-10 |
| SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002) (K250645) | Haemoband Surgical, Ltd. | 2025-10-09 |
| DIASAFEplusUS (F00013010) (K251851) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| Orca Air/Water and Suction Valves (K252910) | Boston Scientific | 2025-10-09 |
| Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U) (K250187) | Olympus Medical Systems Corporation | 2025-10-07 |
| Prodeon Urethral Sheath System (K252572) | Prodeon Medical, Inc. | 2025-10-07 |
| Heylo™ System (K252140) | Coloplast Corp. | 2025-10-06 |
| MAGENTIQ-COLO (ME-APDS) (K252178) | Magentiq Eye, Ltd. | 2025-10-03 |