| Sphincterotome (K201121) | Hangzhou AGS MedTech Co., Ltd. | 2021-02-05 |
| Monopolar Hook (K203603) | Human Xtensions , Ltd. | 2021-02-01 |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K203223) | Steris | 2021-01-28 |
| Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 (K201897) | Richard Wolf Medical Instruments Corporation | 2021-01-15 |
| VMCore Biopsy Needle (K201650) | Uro-1, Inc. | 2021-01-15 |
| Lockado Repositionable Hemostasis Clip (K202333) | Micro-Tech (Nanjing) Co., Ltd. | 2021-01-14 |
| BioGuard EUS Air/Water and Suction Valves (K202104) | STERIS Corporation | 2021-01-14 |
| MyOnyx System (K201014) | Thought Technology , Ltd. | 2021-01-13 |
| Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm (K203397) | Biopsybell S.R.L. | 2021-01-11 |
| BioGuard Air/Water and Suction Valves (K203630) | Steris Corporations | 2021-01-08 |
| Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B (K200769) | Wilson Instruments (Sha) Co., Ltd. | 2021-01-06 |
| Applied Medical Anoscope (K200021) | Applied Medical Resources | 2021-01-06 |
| PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K203166) | Pentax of America, Inc. | 2020-12-30 |
| Foley Balloon Catheter for Urology (K201776) | Apollon Co., Ltd. | 2020-12-30 |
| First Relief v1 (K202940) | Dyansys, Inc. | 2020-12-29 |
| Optiflux Series of Dialyzers F160NR, F180NR, F200NR (K203062) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-12-28 |
| Acute Dual Lumen Hemodialysis Catheter (K200426) | Health Line International Corporation | 2020-12-24 |
| SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set (K193670) | Quanta Dialysis Technologies, Ltd. | 2020-12-23 |
| EndoRotor Device (DEN200016) | Interscope, Inc. | 2020-12-23 |
| Locking device (K202237) | Hangzhou AGS MedTech Co., Ltd. | 2020-12-23 |
| SoloAsisst II, Voice Control (K200473) | Aktormed GmbH | 2020-12-22 |
| Da Vinci SP Surgical System (K202968) | Intuitive Surgical, Inc. | 2020-12-22 |
| Advanix Biliary Stent with NaviFlex RX Delivery System (K203162) | Boston Scientific Corporation | 2020-12-18 |
| KARL STORZ ICG Imaging System (K202925) | Karl Storz Endoscopy_America, Inc. | 2020-12-17 |
| Disposable Stone Extraction basket (K201509) | Hangzhou AGS MedTech Co., Ltd. | 2020-12-16 |
| Prefilled Syringe (K202698) | Hangzhou Primecare Medical Co., Ltd. | 2020-12-15 |
| X-Tack Endoscopic HeliX Tacking System (K201808) | Apollo Endosurgery, Inc. | 2020-12-15 |
| AquaPulse Irrigation Tubing (K202560) | Ga Health Company Limited | 2020-12-10 |
| da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) (K202834) | Intuitive Surgical, Inc. | 2020-12-10 |
| ClearPetra Suction-Evacuation Sheath (K203119) | Well Lead Medical Co., Ltd. | 2020-12-09 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (K202661) | Olympus Medical Systems Corp. | 2020-12-08 |
| TubeClear System (K200646) | Actuated Medical, Inc. | 2020-12-04 |
| ORISE ProKnife (K200404) | Boston Scientific Corporation | 2020-12-03 |
| RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector (K203199) | STERIS Corporation | 2020-12-01 |
| Parallel (DEN200029) | Mahana Therapeutics, Inc. | 2020-11-25 |
| Nipro Dry Complete Dry Acid Concentrate for Hemodialysis (K193155) | Nipro Renal Solutions USA, Corp. | 2020-11-25 |
| TIPCAM1 Rubina Video Endoscope System (K201526) | Karl Storz Endoscopy America | 2020-11-20 |
| Dornier MAGELLAN Ureteral Access Sheath (K201815) | Dornier Medtech America, Inc. | 2020-11-20 |
| Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System (K201867) | Baxter Healthcare Corporation | 2020-11-19 |
| GlidePath 7.5F Long-Term Dialysis Catheter (K202150) | C.R. Bard, Inc. | 2020-11-18 |
| Disposable Trocar (K202931) | Wuxi Shukang Medical Appliance Co., Ltd. | 2020-11-17 |
| SpeediCath Compact Set (K200820) | Coloplast | 2020-11-13 |
| da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (K202571) | Intuitive Surgical, Inc. | 2020-11-12 |
| BioShield biopsy valve EUS - Linear (K202583) | STERIS Corporation | 2020-11-06 |
| Gabriel 3 Way EnFit Valve (K201741) | Syncro Medical Innovations, Inc. | 2020-11-05 |
| SPY-PHI System with SPY-PHI Fluorescence Assessment Software (K202244) | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020-11-05 |
| Blue Beacon Submucosal Injectable Solution (K200071) | Micro-Tech (Nanjing) Co., Ltd. | 2020-11-03 |
| SpeediCath Compact Set (K192904) | Coloplast | 2020-11-02 |
| FUJIFILM Distal End Cap (K203028) | Fujifilm Corporation | 2020-10-30 |
| Nelson Sentinel Series Basic Chlorine Sentinel (K193169) | Nelson Environmental Technologies, Inc. | 2020-10-29 |
| Nutriglide(TM) Nasal Feeding Tube (K202539) | Applied Medical Technology, Inc. | 2020-10-29 |
| Visera Elite II Video System Center (K202646) | Olympus Medical Systems Corp. | 2020-10-29 |
| Flexible Video Cysto-Urethroscope (C-view) (K202957) | KARL STORZ Endoscopy-America, Inc. | 2020-10-29 |
| G-EYE System (K202469) | Smart Medical Systems , Ltd. | 2020-10-26 |
| PleurX Peritoneal Catheter System (K201155) | Care Fusion | 2020-10-21 |
| Single Use Rotatable and Repositionable Hemoclip (K201771) | Anrei Medical (Hangzhou) Co., Ltd. | 2020-10-19 |
| Foley Catheter with Temperature Sensor (K200757) | Deroyal Industries, Inc. | 2020-10-15 |
| Medline ENfit OTC Feeding Syringe (K202285) | Medline Industries, Inc. | 2020-10-09 |
| BIOTEQ Drainage Catheter Set (One Step Type) (K200103) | Bioteque Corporation | 2020-10-09 |
| Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares (K202478) | Boston Scientific Corporation | 2020-10-08 |
| Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 (K193542) | Bellco Srl | 2020-10-08 |
| Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) (K202592) | Stryker | 2020-10-08 |
| ClearEndoclip (K200217) | Finemedix Co., Ltd. | 2020-10-05 |
| Nutricare Clear-ISOSAF Nasogastric Feeding Tube (K202357) | Three Circles Consulting Limited | 2020-10-01 |
| Wiygul Catheter (K202566) | Big Blue Biotech, Inc. | 2020-09-30 |
| EverLift Submucosal Lifting Agent (K202376) | Gi Supply, Inc. | 2020-09-30 |
| Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) (K200557) | Jiangsu Shenli Medical Production Co., Ltd. | 2020-09-28 |
| da Vinci SP Surgical System (K192717) | Intuitive Surgical, Inc. | 2020-09-28 |
| EndoGI S-Path Biliary Stent System (K202477) | Endo GI Medical | 2020-09-24 |
| Optiflux F180NR Dialyzer (K192707) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-21 |
| CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line (K201207) | Fresenius Medical Care Renal Therapies Group, LLC | 2020-09-18 |
| Ran-Flex-B Bone Marrow Aspiration Needle (K202287) | Ranfac Corporation | 2020-09-18 |
| Tulsa-Pro System (K202286) | Profound Medical, Inc. | 2020-09-16 |
| Disposable Enteral Feeding Syringe with Enfit Connector (K193657) | Shinva Ande Healthcare Apparatus Co., Ltd. | 2020-09-12 |
| Arthrex NanoScope System (K201134) | Arthrex, Inc. | 2020-09-04 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (K202176) | Medical Components, Inc. (dba MedComp) | 2020-09-03 |
| Endofresh Digestive Endoscopy System (K192704) | Huizhou Xzing Technology Co., Ltd. | 2020-09-02 |
| SmartHDM-510 System (K201765) | Mesa Laboratories, Inc. | 2020-09-02 |
| Endoscope Reprocessor OER-Elite (K201920) | Olympus Medical Systems Corp. | 2020-09-01 |
| Image1 S CCU, Image1 S 4U Camera Head (K201135) | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 |
| Resolution 360™ ULTRA Clip (K193424) | Boston Scientific Corporation | 2020-09-01 |
| Temno Elite Biopsy System (K201166) | Merit Medical Systems, Inc. | 2020-08-28 |
| OES Elite Ureteroscopes and Accessories (K200369) | Olympus Winter & Ibe GmbH | 2020-08-28 |
| Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer (DEN190042) | Baxter Healthcare Corporation | 2020-08-28 |
| DIMI RRT System (K193005) | Dialco Medical, Inc. | 2020-08-28 |
| Konix Anti-Fog Solution (K190864) | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | 2020-08-27 |
| VersaOne Reusable Positioning Trocar System (K201805) | Covidien | 2020-08-26 |
| FUJIFILM Video Laparoscope (K202130) | Fujifilm Corporation | 2020-08-20 |
| Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System (K202012) | Devicor Medical Products, Inc. | 2020-08-18 |
| HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head (K201399) | Karl Storz-Endoscopy-America, Inc. | 2020-08-17 |
| Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices (K201244) | Transmed7, LLC | 2020-08-07 |
| Disposable Laparoscope Trocar (K201641) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2020-08-06 |
| Vesco Medical Extension Feeding Set (K192991) | Vesco Medical, LLC | 2020-08-03 |
| Reprocessed Endoscopic Trocars and Sleeves (K201511) | Stryker Sustainability Solutions | 2020-07-31 |
| UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge (K201837) | Neotract, Inc. | 2020-07-31 |
| Cyber Blade (K192499) | SIDAM S.r.l. | 2020-07-31 |
| BD Univia RightFit Enteral Extension Sets and Transitional Adapters (K200082) | Mps Medical, Inc. | 2020-07-30 |
| SpeediCath Soft (K200142) | Coloplast | 2020-07-30 |
| Connected OR Hub with Voice Control, Connected OR Hub with Device Control (K201434) | Stryker | 2020-07-28 |