| Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing (K221310) | Changzhou Endoclean Medical Device Co., Ltd. | 2022-10-07 |
| Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) (K222737) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-10-05 |
| Elastic Traction System (K222354) | Micro-Tech (Nanjing) Co., Ltd. | 2022-10-03 |
| DoubleChek DC-1001 (K212316) | Nasogastric Feeding Solutions, Ltd. | 2022-09-30 |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222849) | Steris | 2022-09-30 |
| 8mm Monopolar Curved Scissors (K210478) | Iconocare Health | 2022-09-30 |
| CORE-SPORT (K220081) | Incore Co., Ltd. | 2022-09-28 |
| EndoGI S-Path Biliary Stent System (K222627) | Endo GI Medical | 2022-09-28 |
| Clean Connecting Tube (K220785) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-09-27 |
| Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300) (K222602) | Zhuhai Pusen Medical Technology Co., Ltd. | 2022-09-26 |
| Disposable Polyp Snare (K220089) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-09-22 |
| MCB UNIT Model: V10GMCBUS (K222542) | Lamidey Noury Medical | 2022-09-21 |
| SpeediCath Flex Set (K222059) | Coloplast | 2022-09-21 |
| Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip (K222503) | Boston Scientific Corporation | 2022-09-14 |
| Female IC (Not Finalized) (K213575) | Hollister Incorporated | 2022-09-13 |
| Plasma Shield (K221533) | Plasmatica, Ltd. | 2022-09-12 |
| NeoNavia Biopsy System (K220595) | Neodynamics AB | 2022-09-08 |
| Disposable Endoscope Valves System (K221331) | Changzhou Endoclean Medical Device Co., Ltd. | 2022-09-08 |
| HD-550 Video Endoscope System (K222020) | Sonoscape Medical Corp. | 2022-09-08 |
| AXIOS Stent and Electrocautery-Enhanced Delivery System (K220112) | Boston Scientific Corporation | 2022-09-07 |
| TULSA-PRO System (K211858) | Profound Medical, Inc. | 2022-09-06 |
| Smith+Nephew INTELLIO Tablet (K221929) | Smith+Nephew | 2022-09-06 |
| LiNA OperaScope Needle (K221085) | Lina Medical Aps | 2022-09-02 |
| Rusch Intermittent Urethral Catheters (K222279) | Teleflex Medical | 2022-08-29 |
| Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) (K220159) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022-08-26 |
| Vibrant System (DEN210052) | Vibrant, Ltd. | 2022-08-26 |
| LapBox Tissue Containment Removal System (K221365) | Ark Surgical, Ltd. | 2022-08-25 |
| AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (K222543) | Steris | 2022-08-25 |
| Disposable Endoscope Injection Needle (K220292) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 |
| FUJIFILM Ultrasonic Endoscope EG-740UT (K221238) | Fujifilm Corporation | 2022-08-19 |
| 1688 4K Camera System with Advanced Imaging Modality (K222130) | Stryker | 2022-08-19 |
| OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 (K221824) | Cipher Surgical Limited | 2022-08-19 |
| da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments (K214095) | Intuitive Surgical, Inc. | 2022-08-15 |
| SKOUT Software (K213686) | Iterative Scopes, Inc. | 2022-08-12 |
| Hemo-Lyte C Cartridge (K202508) | Di-Chem, Inc. | 2022-08-12 |
| Blue Eye (TS-905) (K220434) | The Standard Co., Ltd. | 2022-08-12 |
| Erbe's Tubing/Cap Sets (K221177) | Erbe USA, Inc. | 2022-08-11 |
| LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (K221385) | Ovesco Endoscopy AG | 2022-08-11 |
| Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952) | Fujifilm Corporation | 2022-08-04 |
| MANTIS Clip (K221124) | Boston Scientific Corporation | 2022-08-04 |
| Injection Needle (K213914) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2022-07-29 |
| Tablo Hemodialysis System (K211370) | Outset Medical, Inc. | 2022-07-29 |
| Gastrointestinal Boundary Identifier (GIBI HD) (K221898) | Reshape Lifesciences | 2022-07-28 |
| Single Use Cytology Brush (K220063) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 |
| AquaA (K213507) | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| AccuMeasure System (DEN210032) | RQMIS, Inc. | 2022-07-26 |
| Gastric Lightguide (GLG) (K212407) | Naser Dib Gabinet Lekarksi Nasmed | 2022-07-26 |
| Insufflation Retention Device (K213773) | Bpendo, LLC | 2022-07-21 |
| Biofeedback Nerve and Muscle Stimulator (K220161) | Shenzhen Konmed Technology Co., Ltd. | 2022-07-20 |
| Hemoclip (K213143) | Hangzhou AGS MedTech Co., Ltd. | 2022-07-12 |
| APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System (DEN210045) | Apollo Endosurgery, Inc. | 2022-07-12 |
| E-Brik Visualization Assistant (K221293) | Jdi Surgical, Inc. | 2022-07-07 |
| Disposable Semi Automatic Biopsy Instrument (K212820) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| Disposable Biopsy Refill Needle (K212819) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| Disposable Coaxial Biopsy Needle (K212822) | Suzhou Leapmed Healthcare Corporation | 2022-07-06 |
| NovaCore Semi-Automatic Biopsy Instrument (K213232) | Argon Medical Devices | 2022-07-01 |
| 2-Way 100% Silicone ClearTract Catheter (K221625) | Silq Technologies Corporation | 2022-07-01 |
| 780 nm L11 LED Light Source with AIM (K221611) | Stryker | 2022-06-29 |
| Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare (K220790) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-27 |
| VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula (K213818) | Covidien | 2022-06-27 |
| CORE-CLIP (K213338) | Incore Co., Ltd. | 2022-06-23 |
| GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (K213283) | Convatec Limited | 2022-06-22 |
| CORE-Trocar (K211148) | Incore Co., Ltd. | 2022-06-21 |
| SPY Laparoscope (K221217) | Stryker | 2022-06-17 |
| Disposable Endoscopy Adapter Set (K220210) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-17 |
| Logic Hd camera head green, System green (K212808) | Richard Wolf Medical Instruments Corporation | 2022-06-14 |
| PERF-GEN Pulsatile Perfusion Solution (K221386) | Institut Georges Lopez | 2022-06-14 |
| BEL-GEN Cold Storage Solution (K221387) | Institut Georges Lopez | 2022-06-14 |
| ProdiGI (DEN220006) | Covidien, LLC | 2022-06-13 |
| Disposable Hemostatic Closure Clip Device (K220157) | Micro-Tech (Nanjing) Co., Ltd. | 2022-06-13 |
| Niti-S Biliary Slim M Stent (K221071) | Taewoong Medical Co., Ltd. | 2022-06-09 |
| Cysto-Gastro-Sets (K211909) | G-Flex Europe Sprl | 2022-06-09 |
| Nasogastric Feeding Tubes - ENFit Port - PVC (K213258) | Cair Lgl | 2022-06-09 |
| ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits (K213185) | Coloplast Corp. | 2022-06-08 |
| Lap-Band System Calibration Tube (K220455) | Reshape Lifesciences | 2022-06-07 |
| Multi-Band Ligator (K213223) | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| Disposable Polypectomy Snare (K213222) | Beijing Zksk Technology Co., Ltd. | 2022-06-06 |
| Gastric Alimetry System (K213924) | Alimetry , Ltd. | 2022-06-03 |
| Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle (K214063) | Guangzhou Shengwei Medical Devices Co., Ltd. | 2022-06-03 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (K214089) | Fujifilm Corporation | 2022-06-03 |
| Endoscopic Injection Needle (K213239) | Beijing Zksk Technology Co., Ltd. | 2022-06-02 |
| FROG Forceps Valve (VAL1-F1-100) (K221264) | Fujifilm Medwork GmbH | 2022-06-01 |
| Single Use Hemoclip (K212669) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-27 |
| Senhance Surgical System (K220889) | Asensus Surgical, Inc. | 2022-05-27 |
| 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (K214046) | Stryker | 2022-05-25 |
| Single Use Ureteral Access Sheath (K220065) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 |
| Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection (K213174) | Cardinalhealth | 2022-05-19 |
| Siren SGT (K220218) | Tools For Surgery, LLC | 2022-05-18 |
| Telepack + (K221174) | Karl Storz Endoscopy America, Inc. | 2022-05-13 |
| HDF Assist Mudule, HDF Infusion Set and Substitution Filter (K210575) | Nephros | 2022-05-13 |
| Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate (K212620) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-05-12 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K220587) | Olympus Medical Systems Corp. | 2022-05-11 |
| Compass BDS Biliary Stent (K213946) | Cook Ireland, Ltd. | 2022-05-09 |
| SpyGlass Discover Balloon Dilation Catheter (K212582) | Boston Scientific Corporation | 2022-05-06 |
| Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible (K211021) | Micro-Tech (Nanjing) Co., Ltd. | 2022-05-06 |
| BONREE Nelaton Catheter (K212430) | Bonree Medical Co., Ltd. | 2022-04-29 |
| Monarch Platform, Urology (K213334) | Auris Health, Inc. | 2022-04-29 |
| SpeedCath Compact Male (K210250) | Coloplast | 2022-04-26 |
| SnapLoc Wire Lock (K213483) | Wilson Cook Medical | 2022-04-26 |
| Promisemed Fine Biopsy Needle (K213683) | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-22 |