| DT-703 (K221233) | Ecotron Co., Ltd. | 2022-06-27 |
| VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula (K213818) | Covidien | 2022-06-27 |
| T-FIX® 3DSI Joint Fusion System (K214123) | Cutting Edge Spine, LLC | 2022-06-24 |
| TRAUS ENDO (K212043) | Saeshin Precision Co., Ltd. | 2022-06-24 |
| 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) (K220942) | 3M Company | 2022-06-24 |
| Intelligence LaserComb (K213789) | Yibin Yingtong Intelligent Technology Co., Ltd. | 2022-06-24 |
| Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834) | Centers for Disease Control and Prevention | 2022-06-24 |
| ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (K220801) | Abbott Diagnostics Scarborough, Inc. | 2022-06-24 |
| Sugita AVM Microclip Applier (K221524) | Mizuho America, Inc. | 2022-06-24 |
| OTOPLAN (K220300) | Cascination AG | 2022-06-24 |
| Noris Medical Dental Implants System - Cortical (K210852) | Noris Medical , Ltd. | 2022-06-24 |
| Secret Duo (K213250) | Ilooda Co,., Ltd. | 2022-06-24 |
| EZYPOR (K212741) | Fci (France Chirurgie Instrumentation) Sas | 2022-06-24 |
| Procedure Mask (K220377) | Little Rapids Corporation | 2022-06-24 |
| RoughRider Aurora Manual Wheelchair (K200715) | Roughrider America, LLC | 2022-06-24 |
| MAGNETOM Free.Max, MAGNETOM Free.Star (K220575) | Siemens Medical Solutions USA, Inc. | 2022-06-24 |
| FlexBoardTM, EagleBoardTM, BreastBoard SXTM (K213439) | Macromedics BV | 2022-06-24 |
| BentrioTM Allergy Blocker (K213114) | Altamira Therapeutics, Inc. | 2022-06-24 |
| EZYPRO ECG Recorder (Model: UG02) (K213233) | Sigknow Biomedical Co., Ltd. | 2022-06-23 |
| Axial3D Cloud Segmentation Service (K221511) | Axial Medical Printing Limited | 2022-06-23 |
| HD Mediastinoscope (K213194) | Karl Storz Endoscopy America, Inc. | 2022-06-23 |
| EDEN Spinal Fixation System (K201788) | Jmt Co., Ltd. | 2022-06-23 |
| CoLumbo (K220497) | Smart Soft Healthcare AD | 2022-06-23 |
| Ultrasound System SONIMAGE MX1 (K220993) | Konica Minolta, Inc. | 2022-06-23 |
| BreathID Hp Lab System, BreathID Smart System (K220494) | Meridian Bioscience Israel , Ltd. | 2022-06-23 |
| Excipio SV Thrombectomy Device (K221204) | Contego Medical, Inc. | 2022-06-23 |
| ZEPTO Precision Capsulotomy System (K221188) | Centricity Vision, Inc. | 2022-06-23 |
| maxmorespine Bipolar Electrodes (K211173) | Hoogland Spine Products, GmbH | 2022-06-23 |
| Mural Perinatal Surveillance (K220732) | Ge Medical Systems Information Technologies, Inc. | 2022-06-23 |
| Catalyst R1 Reverse Shoulder System (K213349) | Catalyst Orthoscience, Inc. | 2022-06-23 |
| Introcan Safety 2 IV Catheter (K220756) | B.Braun Medical, Inc. | 2022-06-23 |
| SYLFIRM X (K213612) | VIOL Co., Ltd. | 2022-06-23 |
| CORE-CLIP (K213338) | Incore Co., Ltd. | 2022-06-23 |
| bite away neo (K220514) | mibeTec GmbH | 2022-06-23 |
| Glidewell 3DP Denture Base Resin (K213765) | Prismatik Dentalcraft, Inc. | 2022-06-22 |
| GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter (K213283) | Convatec Limited | 2022-06-22 |
| TC Gloves (K221185) | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-22 |
| HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote (K213682) | Edwards Lifesciences, LLC | 2022-06-22 |
| Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (K213345) | Path Medical GmbH | 2022-06-22 |
| Qlicksmart BladeFlask UNIVERSAL (K213274) | Qlicksmart Pty , Ltd. | 2022-06-22 |
| HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) (K221008) | Shanghai Handy Medical Equipment Co., Ltd. | 2022-06-22 |
| Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System (K220413) | Canary Medical USA, LLC | 2022-06-22 |
| Klassic Knee System (K211877) | Total Joint Orthopedics, Inc. | 2022-06-22 |
| T3 Platform Software (K213230) | Etiometry, Inc. | 2022-06-22 |
| Disposable Nitrile Powder-Free Examination Gloves (K221192) | Shandong Maida Medical Technology Co., Ltd. | 2022-06-22 |
| Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) (K212665) | Huizhou Xiaoou Technology Co., Ltd. | 2022-06-22 |
| Nitrile Examination Gloves (K213739) | Hangzhou Runheng Medical Co., Ltd. | 2022-06-22 |
| Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh (K220586) | Sofradim Production | 2022-06-22 |
| Esophageal TTS Stent (K221482) | Taewoong Medical Co., Ltd. | 2022-06-22 |
| Vial Adapter Ø13mm (K220856) | Avenir Performance Européenne Medical (Apem) | 2022-06-21 |
| Stainless Turbine (K203791) | Nakanishi, Inc. | 2022-06-21 |
| Aspirex Thrombectomy System (K220270) | C.R. Bard, Inc. | 2022-06-21 |
| Venue Go (K220800) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022-06-21 |
| CORE-Trocar (K211148) | Incore Co., Ltd. | 2022-06-21 |
| AcQMap 3D Imaging and Mapping Catheter, Model 900009 (K210766) | Acutus Medical, Inc. | 2022-06-21 |
| Revaree Plus Vaginal Suppositories (K213220) | Farma-Derma S.R.L. | 2022-06-21 |
| Syngo Carbon Space VA20A (K213665) | Siemens Healthcare GmbH | 2022-06-21 |
| NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System (K220478) | Nu Vasive, Incorporated | 2022-06-21 |
| Lumenis Y&R Laser System (K211979) | Lumenis, Inc. | 2022-06-21 |
| Sherlock (K220482) | Open Implants, LLC | 2022-06-21 |
| NeuroLine Disposable Cranial Perforator with Hudson end (K213228) | Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. | 2022-06-20 |
| Zuno Smart Sterilization Container (DEN210004) | Zuno Medical, Inc. | 2022-06-17 |
| SPY Laparoscope (K221217) | Stryker | 2022-06-17 |
| Langston dual lumen catheter (K221470) | Vascular Solutions, LLC | 2022-06-17 |
| ElucidVivo A.3 (K221463) | Elucid Bioimaging, Inc. | 2022-06-17 |
| ARIA Radiation Therapy Management (v16.1 MR3) (K221408) | Varian Medical Systems, Inc. | 2022-06-17 |
| ART-PLAN (K220813) | Therapanacea | 2022-06-17 |
| Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 (K220572) | Ceragem Co., Ltd. | 2022-06-17 |
| Baby Gorilla/Gorilla Plating System (K221465) | Paragon 28, Inc. | 2022-06-17 |
| Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode (K212871) | Galvanize Therapeutics, Inc. | 2022-06-17 |
| IDx-DR v2.3 (K213037) | Digital Diagnostics, Inc. | 2022-06-17 |
| Freeze’n Clear Skin Clinic Warts & Tags (K211099) | Cryoconcepts LP | 2022-06-17 |
| CipherOx CRI Tablet (K213255) | Flashback Technologies, Inc. | 2022-06-17 |
| MyOnyx System (K213197) | Thought Technology , Ltd. | 2022-06-17 |
| restor3d TiDAL Lumbar Interbody Fusion Device (K220523) | Restor3D | 2022-06-17 |
| Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile (K220431) | One Glove Industrial Sdn Bhd | 2022-06-17 |
| Disposable Endoscopy Adapter Set (K220210) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-17 |
| RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System (K221117) | Samsung Medison Co., Ltd. | 2022-06-17 |
| Ion Endoluminal System (IF1000) (K220299) | Intuitive Surgical, Inc. | 2022-06-16 |
| Seer Home (K212788) | Seer Medical Pty, Ltd. | 2022-06-16 |
| Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) (K212426) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2022-06-16 |
| FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (K201037) | Taidoc Technology Corporation | 2022-06-16 |
| WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System (K220399) | OTU Medical, Inc. | 2022-06-16 |
| Dentis s-Clean Abutment Mini (K220440) | Dentis Co., Ltd. | 2022-06-16 |
| Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A (K213504) | Canon Medical Systems Corporation | 2022-06-16 |
| Wireless Digital Flat Panel Detector (K221345) | Iray Technology Taicang , Ltd. | 2022-06-16 |
| TC Gloves (K221186) | Thanh Cong Pharmaceutical and Trading Company Limited | 2022-06-16 |
| 1st Glove Blue Nitrile Examination Gloves Powder Free (K221226) | Koove Iot Pvt. , Ltd. | 2022-06-16 |
| TLC Unicompartmental Knee System (K212870) | Signature Orthopaedics Pty, Ltd. | 2022-06-16 |
| Custom-made Invisible Aligners (K203624) | Zhejiang Yinchili Medical Technology Co., Ltd. | 2022-06-16 |
| Disposable Vinyl Examination Glove (K220469) | Chifeng Huawei Medical Science&Technology Co., Ltd. | 2022-06-16 |
| DePuy 3D Additive TriFlange Acetabular Cup (K201348) | Depuy International, Ltd. | 2022-06-16 |
| Straumann TLX Variobase C (K220878) | Institut Straumann AG | 2022-06-16 |
| VITROS AFP (K213626) | Ortho Clinical Diagnostics | 2022-06-15 |
| EEG-acp (K212325) | Somnomedics GmbH | 2022-06-15 |
| MEDOJECT fine Pen Needles (K220614) | Chirana T. Injecta | 2022-06-15 |
| ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) (K221448) | Varian Medical Systems, Inc. | 2022-06-15 |
| QardioArm 2 (K220106) | Qardio, Inc. | 2022-06-15 |
| SurgiCase Viewer (K213684) | Materialise NV | 2022-06-15 |
| ZQuiet Advance (K213088) | Sleeping Well, LLC | 2022-06-15 |