| Intrelief (K211263) | Easymed Instruments Co., Ltd. | 2021-12-30 |
| Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) (K212834) | Siyang Threeguard Medical Supplies Co., Ltd. | 2021-12-30 |
| eco-x Series (eco-x, eco-x-s) (K211159) | Hdx Will Corp. | 2021-12-30 |
| Tzoar 207 Negative Pressure Wound Therapy (NPWT) System (K202898) | Lightstone Medical Products (Ningbo) Co, Ltd. | 2021-12-30 |
| Quick-Start Screws (K212547) | Innovate Orthopaedics Limited | 2021-12-30 |
| Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K213538) | Acuity Polymers, Inc. | 2021-12-30 |
| Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers (K211458) | Ningbo Verykind Medical Device Co., Ltd. | 2021-12-30 |
| LiverSmart (K213776) | Resonance Health Analysis Services Pty, Ltd. | 2021-12-29 |
| Goody Gloves, Wincare, TBG Gloves (K213073) | Thai Rubber Gloves Co., Ltd. | 2021-12-29 |
| CONVIVO In Vivo Pathology Suite (K211156) | Carl Zeiss Meditec, AG | 2021-12-29 |
| Flexible Intubation Video Endoscope – Sterile (FIVE-S) (K212656) | Karl Storz Endoscopy America | 2021-12-29 |
| Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM (K213316) | Nihon Kohden Corporation | 2021-12-29 |
| GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (K202101) | Accriva Diagnostics, Inc. | 2021-12-29 |
| Alcon (serafilcon A) soft contact lenses for daily wear (K212806) | Alcon Laboratories, Inc. | 2021-12-28 |
| EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device (K213209) | K1 Medical, LLC | 2021-12-28 |
| ATM Glove (K213016) | Phu Duc Huy Production Trading Services Corporation | 2021-12-28 |
| Sonosite PX Ultrasound System (K213763) | FUJIFILM Sonosite, Inc. | 2021-12-27 |
| Dermoaroma Disposable Nitrile Examination Glove (K212716) | Chuzhou Harmony Gloves Medical Technology Co.,Ltd | 2021-12-27 |
| Sterile Latex Surgical Gloves Powder Free (K212848) | Pentavest Holdings Sdn Bhd | 2021-12-27 |
| Colibri System (K193138) | Copan Wasp Srl | 2021-12-27 |
| Fixone hybrid knotless anchor (K203523) | Aju Pharm Co., Ltd. | 2021-12-25 |
| R3ACT Stabilization System (K211770) | Paragon 28, Inc. | 2021-12-25 |
| Skypro, SP02 Mask (3) (K202255) | Skypro Medical Supplies Company | 2021-12-24 |
| CPL Surgical Face Mask (K213136) | Control Print Limited | 2021-12-24 |
| Nitrile Examination Golves Powder Free (K212921) | Jiangsu Standard Health Co.,Ltd | 2021-12-24 |
| Twist Drills (K213208) | Biomet Microfixation | 2021-12-23 |
| NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty (K203714) | Nu Vasive, Incorporated | 2021-12-23 |
| Contour® next GEN Blood Glucose Monitoring System (K193407) | Ascensia Diabetes Care | 2021-12-23 |
| Altech® Exhalation Valve (Single Limb and Dual Limb) (K210992) | Meditera Tibbi Malzeme San VE Tic AS | 2021-12-23 |
| NBR Synthetic Nitrile Examination Gloves (K212436) | Shandong Langtai International Trade Co., Ltd. | 2021-12-23 |
| Integrity Implants Navigated Instruments (K212088) | Integrity Implants, Inc. | 2021-12-23 |
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| D²RS and D²RS 9090 (K213479) | Stephanix | 2021-12-23 |
| dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T (K213766) | Invivo Corporation | 2021-12-23 |
| Vy Spine™ VyWasher™ Buttress System (K213219) | Vy Spine, LLC | 2021-12-23 |
| SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla (K213547) | Ttk Healthcare Limited | 2021-12-23 |
| Sonomed IV, Sonomed V (K202788) | Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto | 2021-12-23 |
| Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield (K210147) | Unicoglobal, Inc. | 2021-12-22 |
| Solas OR (K213691) | Cirdan Imaging, Ltd. | 2021-12-22 |
| ID-500 iRestore Hair Growth System (K213094) | Freedom Laser Therapy, Inc. | 2021-12-22 |
| Glovmaster Nitrile Examination Glove Powder Free (K212914) | Glovmaster Sdn. Bhd. | 2021-12-22 |
| EdgePro (K213428) | Biolase, Inc. | 2021-12-22 |
| BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle (K210978) | Becton, Dickinson and Company | 2021-12-22 |
| Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors (K213144) | Shen Wei USA, Inc. | 2021-12-22 |
| Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) (K212285) | Oriental Inspiration Limited | 2021-12-22 |
| Ultrast Gel (K211691) | Ultrast, Inc. | 2021-12-22 |
| Encore System (K213159) | Siesta Medical, Inc. | 2021-12-22 |
| Sheath, Stopcock Accessory (K213207) | Olympus Winter & Ibe GmbH | 2021-12-22 |
| Pulse Oximeter (K210305) | Dongguan Lingxin Technologies Co., Ltd. | 2021-12-22 |
| BoneMRI (K202404) | Mriguidance B.V. | 2021-12-22 |
| Claritas iPET (K213140) | Claritas Healthtech Pte, Ltd. | 2021-12-22 |
| SleepRight Select-Comfort Dental Guard (K212767) | Splintek, Inc. | 2021-12-22 |
| EyeBOX (Model EBX-4) (K212310) | Oculogica, Inc. | 2021-12-22 |
| StealthStation S8 Cranial v2.0 (K212397) | Medtronic Navigation | 2021-12-22 |
| Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711) | Neocis, Inc. | 2021-12-22 |
| Non Absorbable Surgical Nylon Suture (K212603) | Shandong Haidike Medical Product Co., Ltd. | 2021-12-22 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. (K211022) | Central Medicare Sdn Bhd | 2021-12-22 |
| iSR’obot Mona Lisa 2.0 (K213411) | Biobot Surgical Pte., Ltd. | 2021-12-22 |
| Oren LED Perioral Light Therapy System (K213024) | Shenzhen Kaiyan Medical CO , Ltd. | 2021-12-22 |
| Diode Laser System GP900A8, Diode Laser System GP900Q8 (K213225) | Shenzhen Gsd Tech Co., Ltd. | 2021-12-22 |
| SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay (K203564) | Immunalysis Corporation | 2021-12-22 |
| SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay (K203647) | Immunalysis Corporation | 2021-12-22 |
| reVive Light Therapy Essentials (K210968) | Led Technologies, Inc. | 2021-12-21 |
| Restoration Modular 115mm Conical Distal Stem (K213129) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2021-12-21 |
| FIX-C PEEK Anterior Cervical Interbody System (K212266) | Jeil Medical Corporation | 2021-12-21 |
| DRSplus (K213705) | Centervue S.P.A. | 2021-12-21 |
| iCOquit® Smokerlyzer® (K211918) | Bedfont Scientific, Ltd. | 2021-12-21 |
| CavaClear Laser Sheath (DEN210024) | Spectranetics, Inc. | 2021-12-21 |
| InCore Subtalar System (K213301) | Nextremity Solutions, Inc. | 2021-12-21 |
| TearCare System (K213045) | Sight Sciences, Inc. | 2021-12-21 |
| Progreat Lambda (K211078) | Terumo Clinical Supply Co., Ltd. | 2021-12-21 |
| TheraFace LED (K212155) | Theragun, Inc. | 2021-12-21 |
| BU-CAD (K210670) | Taihao Medical, Inc. | 2021-12-21 |
| The Progen™ Trochanteric Nail System (K211086) | Ortho Development Corporation | 2021-12-21 |
| CT3000Pro (K212830) | Srs Medical | 2021-12-21 |
| BellaTek Encode Emergence Healing Abutments (K212730) | Biomet 3i, LLC | 2021-12-21 |
| TRI-matrix Implant Line (K203660) | Tri Dental Implants Int. AG | 2021-12-21 |
| OSSIOfiber Compression Screw, 3.5mm (K213596) | OSSIO , Ltd. | 2021-12-21 |
| Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) (K212613) | Koon Seng Sdn Bhd | 2021-12-21 |
| Meticuly Patient-Specific Titanium Mesh Implant (K210099) | Meticuly Co., Ltd. | 2021-12-21 |
| Wesper Lab (K203343) | Wesper, Inc. | 2021-12-21 |
| Vision (K212770) | Softsmile, Inc. | 2021-12-21 |
| qXR-BT (K212690) | Qure.Ai Technologies | 2021-12-21 |
| SURGmatic S15 L Pro (K213139) | Kavo Dental GmbH | 2021-12-21 |
| CardiaMend Pericardial and Epicardial Reconstruction Matrix (K210331) | Helios Cardio, Inc. | 2021-12-21 |
| N1 TiUltra TCC Implant System (K211109) | Nobel Biocare Services AG | 2021-12-21 |
| Vinyl Examination Gloves (K213006) | Taian Hengchang Medical Technology Co., Ltd. | 2021-12-21 |
| Xenco Medical Multilevel CerviKit (K213456) | Xenco Medical, LLC | 2021-12-21 |
| IPL Home Use Hair Removal Device (K211185) | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 2021-12-20 |
| EchoGo Core (2.0) (K213275) | Ultromics Limited | 2021-12-20 |
| Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K212776) | Innovative Health, LLC | 2021-12-20 |
| AspenMed+ (K213076) | Aspen Glove Sdn. Bhd. | 2021-12-20 |
| Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) (K211865) | Liao Ning Shangwei Medical Products Co., Ltd. | 2021-12-20 |
| Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) (K211750) | National Bridge Industrial (S.Z.) Co., Ltd. | 2021-12-20 |
| Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml (K203741) | Thermo Fisher Scientific | 2021-12-20 |
| TCAT TKA Instrument Tray (K203468) | THINK Surgical, Inc. | 2021-12-20 |
| AdVance XP Male Sling System (K211847) | Boston Scientific Corporation | 2021-12-20 |
| Vy Spine ClariVy Cervical IBF System (K212715) | Vy Spine, LLC | 2021-12-20 |
| 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) (K211521) | 3M Healthcare Business Group | 2021-12-20 |
| First Relief (K212859) | Dyansys, Inc. | 2021-12-20 |