| Avanos* CORTRAK* 2 Enteral Access System (EAS) (K220588) | Avanos Medical, Inc. | 2022-04-22 |
| 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) (K220895) | Stryker | 2022-04-22 |
| Saberscope5 Laparoscope (K220872) | Xenocor, Inc. | 2022-04-20 |
| Lilliput APD System (K212522) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 |
| WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (K212202) | OTU Medical, Inc. | 2022-04-13 |
| Keffort (MC-100, MC-100A) (K213133) | Oriental Inspiration Limited | 2022-04-13 |
| BIOTEQ Drainage Catheter BT-PDS-series (K210419) | Bioteque Corporation | 2022-04-13 |
| G-EYE System (K220158) | Smart Medical Systems , Ltd. | 2022-04-11 |
| Cellvizio 100 series system with confocal Miniprobes (K220477) | Mauna Kea Technologies | 2022-04-11 |
| DORA Disposable A.V. Fistula Needle Sets (K213015) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2022-04-08 |
| Balloon Dilatation Catheter (K213578) | Hangzhou AGS MedTech Co., Ltd. | 2022-04-06 |
| Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set (K212216) | Baxter Healthcare Corporation | 2022-04-01 |
| Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) (K210052) | Saneso, Inc. | 2022-04-01 |
| HD-550 Video Endoscope System (K211882) | Sonoscape Medical Corp. | 2022-04-01 |
| Alexis Contained Extraction System (K211043) | Applied Medical Resources Corporation | 2022-03-31 |
| BD Trek Powered Bone Biopsy System (K213896) | Bard Peripheral Vascular | 2022-03-30 |
| Guidewire Locking Device (K220247) | Micro-Tech (Nanjing) Co., Ltd. | 2022-03-29 |
| ArthroFree Wireless Surgical Camera System (K213860) | Lazurite Holdings, LLC | 2022-03-23 |
| Multi-Functional Electrosurgical Knife (K212999) | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 |
| 15L Cycler Drainage Bag (K214016) | Baxter Healthcare Corporation | 2022-03-18 |
| RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm (K213444) | Ureteral Stent Company | 2022-03-17 |
| EndoGator Endoscopy Irrigation Tubing (K220395) | STERIS Corporation | 2022-03-11 |
| Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide (K220361) | STERIS Corporation | 2022-03-10 |
| 4K UHD LCD Monitor OEV321UH (K220069) | Olympus Medical Systems Corp. | 2022-03-09 |
| SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) (K203637) | Coloplast | 2022-03-08 |
| Hemoclip (K211787) | Hangzhou AGS MedTech Co., Ltd. | 2022-03-03 |
| Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge (K213135) | Chirurgie Innovation | 2022-03-02 |
| Bio Fluff System (K201861) | Gnali Bocia S.R.L. | 2022-03-02 |
| ENFit enteral syringes (NUTRIFIT) (K211661) | Pentaferte Italia S.R.L. | 2022-02-28 |
| Sclerotherapy Needle (K212668) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 |
| Flexible Video-Choledo-Cysto-Ureteroscope System (K211686) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K213710) | Intuitive Surgical, Inc. | 2022-02-17 |
| LoFric Elle (K211212) | Dentsply Sirona | 2022-02-17 |
| NovoFlow Reinforced Ureteral Stent (K213186) | Coloplast Corp. | 2022-02-16 |
| EvoEndo Single-Use Endoscopy System (K213606) | EvoEndo, Inc. | 2022-02-14 |
| Pure-Vu EVS System (K220007) | Motus GI Medical Technologies , Ltd. | 2022-02-10 |
| SDC4K Information Management System with Device and Voice Control Package (K220108) | Stryker Endoscopy | 2022-02-09 |
| CloudCath Peritoneal Dialysis Drain Set Monitoring System (K212658) | Cloudcath | 2022-02-09 |
| Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI (K220053) | Fujifilm Corporation | 2022-02-04 |
| Ambu® aScope™ Gastro, Ambu® aBox™2 (K212382) | Ambu A/S | 2022-02-03 |
| TeesuVac Breast Biopsy Device Mark 1 (K212079) | Teesuvac Aps | 2022-02-02 |
| 8mm Monopolar Curved Scissors (K220023) | Intuitive Surgical, Inc. | 2022-01-31 |
| Intermittent Catheter (Not Finalized) (K211436) | Hollister Incorporated | 2022-01-27 |
| JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (K212868) | Rocamed Sam | 2022-01-26 |
| Revaclear 500, Revaclear 400, Revaclear 300 (K213639) | Baxter Healthcare Corporation | 2022-01-24 |
| KIDNEY ASSIST-transport (K211333) | Xvivo Perfusion AB | 2022-01-20 |
| Entuit PEG, Entuit PEGJ (K213356) | Wilson-Cook Medical, Inc. | 2022-01-20 |
| Disposable Dual Action Tissue Clip (K212748) | Micro-Tech (Nanjing) Co., Ltd. | 2022-01-20 |
| Flexible Video-Uretero-Renoscope SSU System (K212458) | Karl Storz Endoscopy America | 2022-01-20 |
| Wellead Endoscopic Seal (K211814) | Well Lead Medical Co., Ltd. | 2022-01-14 |
| Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit (K213602) | Covidien, LLC | 2022-01-14 |
| SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833) | Medivators, Inc. | 2022-01-14 |
| andorate Suction Valve, andorate Air/Water Valve (K213095) | Ga Health Company Limited | 2022-01-12 |
| G-Tech Wireless Patch System (WPS) (K212954) | G-Tech Medical | 2022-01-10 |
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |
| Servator M SALF Solution (K211842) | S.A.L.F. Spa | 2021-12-20 |
| RF Vapor System (K213627) | Aqua Medical, Inc. | 2021-12-17 |
| Connected OR Hub with Device and Voice Control (K212055) | Stryker Corporation | 2021-12-16 |
| Aspira Peritoneal Drainage System (K212675) | Merit Medical Systems, Inc. | 2021-12-14 |
| 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads (K211997) | Intuitive Surgical, Inc. | 2021-12-10 |
| endomina system (K211309) | Endo Tools Therapeutics S.A. | 2021-12-07 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle (K212852) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 |
| Everyway Incontinence Stimulation System (K213116) | Everyway Medical Instruments Co.,Ltd | 2021-12-03 |
| ArtiSential Trocar (K212500) | Livsmed, Inc. | 2021-12-03 |
| FUJIFILM Video Laparoscope EL-R740M30 (K212950) | Fujifilm Corporaton | 2021-12-02 |
| Sphincterotome / short-wire compatible, Sterile Sphincterotome (K210934) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 |
| Tablo Cartridge (K210782) | Outset Medical, Inc. | 2021-11-26 |
| Regulora (K211463) | Metame Health, Inc. | 2021-11-24 |
| Uretero1 Ureteroscope System (K211347) | STERIS Corporation | 2021-11-23 |
| Exablate Prostate System (K212150) | Insightec, Inc. | 2021-11-23 |
| da Vinci SP Firefly Imaging System (K212101) | Intuitive Surgical, Inc. | 2021-11-23 |
| vPatch (DEN210012) | Virility Medical | 2021-11-23 |
| VS3 Iridium Sytem (K210265) | Visionsense, Ltd. | 2021-11-22 |
| Arthrex Vortex Threaded Bone Marrow Recovery Needle (K213213) | Arthrex, Inc. | 2021-11-19 |
| Urinary Catheter 12 Fr, Urinary Catheter 16 Fr (K211032) | Urogen Pharma, Ltd. | 2021-11-19 |
| EndoScreener (K211326) | Chengdu Wision Medical Device Co., Ltd. | 2021-11-19 |
| Qora Stool Management Kit (K212444) | Cm Technologies, Inc. | 2021-11-17 |
| Enteral Feeding Set (K210854) | Kb Medical (Group), Inc. | 2021-11-16 |
| KARL STORZ ICG Imaging System (K212695) | Karl Storz Endoscopy America | 2021-11-15 |
| Disposable Automatic Core Biopsy Instrument (K212284) | Suzhou Leapmed Healthcare Corporation | 2021-11-10 |
| SoftFix Balloon Trocar (K211577) | Unimax Medical Systems, Inc. | 2021-11-05 |
| 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) (K212511) | Stryker | 2021-11-04 |
| FLUME catheter (K212151) | The Flume Catheter Company, Ltd. | 2021-11-03 |
| Pediatric Nasogastric Feeding Tubes - Single ENFit Port (K210598) | Cair Lgl | 2021-11-02 |
| Balloon BS-3 (K213195) | Fujifilm Corporation | 2021-10-29 |
| DiLumen C2 and Tool Mount (K211819) | Lumendi, LLC | 2021-10-22 |
| Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series (K210618) | Chongqing Jinshan Science & Technology Co., Ltd. | 2021-10-20 |
| PENTAX Medical Video Upper GI Scopes EG17-J10 (K210177) | Pentax of America, Inc. | 2021-10-20 |
| U9000 Plus Ultrafilter (K211035) | Baxter Healthcare Corporation | 2021-10-19 |
| RM4 Control Unit (K211224) | Institut Georges Lopez | 2021-10-15 |
| AFS Medical Sterile Single-Use Access Port System (K202688) | Afs Medical Co. , Ltd. | 2021-10-14 |
| SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) (K212860) | STERIS Corporation | 2021-10-07 |
| Bipolar Coagulation Foreceps (K210406) | Hangzhou AGS MedTech Co., Ltd. | 2021-10-05 |
| PENTAX Medical Auto Leakage Tester SHA-P6 (K212201) | Pentax of America, Inc. | 2021-10-01 |
| D Camera Controller (K211332) | Richard Wolf Medical Instruments Corporation | 2021-10-01 |
| Enteral Pump Syringe (K211593) | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 |
| ENDOtube (K203350) | Nissha Medical Technologies Sas | 2021-09-29 |
| Da Vinci SP Surgical System (K212747) | Intuitive Surgical, Inc. | 2021-09-29 |
| Standard Bougie, 38 Fr. and Hand Pump (K212728) | Standard Bariatrics | 2021-09-23 |
| CT-STOR (K201789) | Energy Delivery Solutions | 2021-09-20 |