| Arkligners (K220835) | Arklign Laboratories | 2022-08-12 |
| SKOUT Software (K213686) | Iterative Scopes, Inc. | 2022-08-12 |
| Zavation VariSync Plate System and VariSync Spacer System (K221049) | Zavation Medical Products, LLC | 2022-08-12 |
| IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 (K221466) | Shenzhen Century Dongyuan Technology CO , Ltd. | 2022-08-12 |
| Intense Pulsed Light Equipment (K220385) | Beijing Globalipl Development Co., Ltd. | 2022-08-12 |
| Hemo-Lyte C Cartridge (K202508) | Di-Chem, Inc. | 2022-08-12 |
| Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets (K221126) | Owen Mumford, Ltd. | 2022-08-12 |
| Vibe SF Self-Fitting Hearing Aid (K220403) | Wsaud A/S | 2022-08-12 |
| EzDent-i / E2 / Prora View/ Smart M Viewer (K222145) | Ewoosoft Co., Ltd. | 2022-08-12 |
| TeraRecon Neuro (K220349) | Terarecon,Inc. | 2022-08-12 |
| Denture Base Polymers (K220680) | Shandong Huge Dental Material Corporation | 2022-08-12 |
| Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System (K202739) | Bioland Technology, Ltd. | 2022-08-12 |
| Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) (K221027) | Allmed Medical (Hubei) Protective Products Co., Ltd. | 2022-08-12 |
| Tasso+ (K221131) | Tasso, Inc. | 2022-08-12 |
| Visibly Digital Acuity Product (K220090) | Visibly, Inc. | 2022-08-12 |
| Blue Eye (TS-905) (K220434) | The Standard Co., Ltd. | 2022-08-12 |
| ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System (K202461) | Smisson-Cartledge Biomedical, LLC | 2022-08-12 |
| aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices (K222082) | Carlsmed, Inc. | 2022-08-12 |
| AI-Rad Companion (Pulmonary) (K213713) | Siemens Healthcare GmbH | 2022-08-11 |
| NEUWAVE Microwave Ablation System and Accessories (K220472) | Neuwave Medical, Inc. | 2022-08-11 |
| KLS Martin IPS Distraction (K220050) | KLS Martin L.P. | 2022-08-11 |
| Arthrex Knotless FiberTak Biceps Suture Anchor (K222161) | Arthrex, Inc. | 2022-08-11 |
| Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem (K220731) | Stryker | 2022-08-11 |
| TERA HARZ DENTURE (K222414) | Graphy, Inc. | 2022-08-11 |
| Medical image processing software (K220910) | Hangzhou Deepwise & League of PHD Technology Co., Ltd. | 2022-08-11 |
| Patient Monitor: RespArray (K220308) | Edan Instruments, Inc. | 2022-08-11 |
| Foundation Dermal Regeneration Scaffold (DRS) Solo (K210949) | Bionova Medical, Inc. | 2022-08-11 |
| OMF ASP System (K220648) | Vha Dean | 2022-08-11 |
| Erbe's Tubing/Cap Sets (K221177) | Erbe USA, Inc. | 2022-08-11 |
| InstaFill Graft Delivery System, SIGNIFY Bioactive (K221737) | Globus Medical, Inc. | 2022-08-11 |
| Novo (K212361) | PathAI, Inc. | 2022-08-11 |
| LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) (K221385) | Ovesco Endoscopy AG | 2022-08-11 |
| Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 (K221879) | Caf Medical Solutions, Inc. | 2022-08-10 |
| KDG Abutments (K221381) | Keystone Dental, Inc. | 2022-08-10 |
| Safety Blood Collection Needles with/without Needle Holder (K220900) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-08-10 |
| CytonPro-5000 (K213524) | Cytonsys, Inc. | 2022-08-10 |
| iSyncWave (K220056) | iMediSync, Inc. | 2022-08-10 |
| UniVit HE, UniVit UHS (K212763) | Visioncare Devices, LLC | 2022-08-10 |
| BLT Dental Implant System (K212364) | Bio Concept Co., Ltd. | 2022-08-10 |
| IMICRYL Composite, Composite Flow Materials (K220077) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 |
| “POINT” Kinguide Robotic-Assisted Surgical System (K220241) | Point Robotics MedTech, Inc. | 2022-08-09 |
| NOVA RESIN dual cure, self adhesive resin cement (K213609) | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 |
| LimFlow V-Ceiver (K222083) | LimFlow, Inc. | 2022-08-09 |
| NextGen Pedicle Screw System (K221776) | Corelink, LLC | 2022-08-09 |
| Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White (K212482) | Sri Trang Gloves (Thailand) Public Company Limited | 2022-08-09 |
| IRIS Pi Q switched Nd YAG laser (K221789) | Bio-Med USA, Inc. | 2022-08-09 |
| DenMat Glutaraldehyde Desensitizer (K222357) | Denmat Holding, LLC | 2022-08-09 |
| dS Sentinelle Breast 16ch 3.0T Coil (K213727) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 |
| dS Sentinelle Breast 16ch 1.5T Coil (K213735) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 |
| ClearPoint Maestro Brain Model (K213645) | ClearPoint Neuro, Inc. | 2022-08-08 |
| Dasky Disposable Sampling Tube (Model name: VSM02) (K211675) | Ningbo Dasky Life Science Co., Ltd. | 2022-08-08 |
| VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) (K212243) | bioMerieux, Inc. | 2022-08-08 |
| Dental Impression Material (K221668) | Chemoment Materials Co.,Ltd | 2022-08-08 |
| Dolphin Imaging 12.0 (K222072) | Patterson Dental Supply, Inc. | 2022-08-08 |
| Reprocesses Umbilical Cable (K221854) | Innovative Health, LLC | 2022-08-06 |
| Pro Guard Nitrile Powder Free Examination Glove (K213934) | Medical Glove Co., Ltd. | 2022-08-06 |
| TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (K220045) | Dk Medivision Co., Ltd. | 2022-08-05 |
| Powder Free Chloroprene Examination Glove Coloured (Blue, Green) (K213993) | Careglove Global Sdn. Bhd. | 2022-08-05 |
| Avéli (K221336) | Revelle Aesthetics, Inc. | 2022-08-05 |
| Neurophet SCALE PET (K221405) | Neurophet., Inc. | 2022-08-05 |
| Spineology Navigation Instruments (K213876) | Spineology, Inc. | 2022-08-05 |
| Unispace SA Cervical Cage (K213791) | Edisoninno Co., Ltd. | 2022-08-05 |
| Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) (K221350) | Rubberex Alliance Products Sdn Bhd | 2022-08-05 |
| MONOFIX PGCL, knotless wound closure device (K212810) | Samyang Holdings Corp., Ltd. | 2022-08-05 |
| FAMA Male Latex Condoms (K220576) | Shanghai Personage Hygiene Products Co., Ltd. | 2022-08-05 |
| Mini-ClotTriever Thrombectomy System (K220887) | Inari Medical | 2022-08-04 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
| CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K211614) | Centermed, Inc. | 2022-08-04 |
| Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952) | Fujifilm Corporation | 2022-08-04 |
| Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay (K220001) | Diazyme Laboratories, Inc. | 2022-08-04 |
| Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) (K220524) | Well-Life Healthcare Limited | 2022-08-04 |
| Actera™ hip system (K221104) | Conformis, Inc. | 2022-08-04 |
| MANTIS Clip (K221124) | Boston Scientific Corporation | 2022-08-04 |
| Masimo CARESCAPE SpO2 – Masimo with SpHb (K221953) | Masimo Corporation | 2022-08-04 |
| MDHearingAid app, MDHearingAid Smart hearing aids (K220303) | Mdhearingaid | 2022-08-04 |
| Bloomi Smooth Water Based Lubricant (K221328) | The Bloomi Inc.. | 2022-08-04 |
| ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed (K212181) | Phadia AB | 2022-08-03 |
| QScreen (K220139) | Path Medical GmbH | 2022-08-03 |
| Customize (K221432) | 3D-Side S.A. | 2022-08-03 |
| Transpara 1.7.2 (K221347) | Screenpoint Medical B.V. | 2022-08-03 |
| Root ZX3 (K213477) | J. Morita USA, Inc. | 2022-08-03 |
| Cannulated Screws (K213614) | Maxxion Medical, LLC | 2022-08-03 |
| Solidence Multipockets (K191131) | Solidence Surgical Corporation | 2022-08-03 |
| BruxZir NOW (K220816) | Prismatik Dentalcraft, Inc. | 2022-08-02 |
| QOCA Portable ECG Monitoring Device (K210179) | Quanta Computer, Inc. | 2022-08-02 |
| iStent infinite Trabecular Micro-Bypass System, Model iS3 (K220032) | Glaukos Corporation | 2022-08-02 |
| IPL hair removal (K221451) | Shenzhen Lizbella Technology Co.,Ltd | 2022-08-01 |
| X-ray Flat Panel Detectors (CareView 1800 RF) (K221549) | Careray Digital Medical Technology Co., Ltd. | 2022-08-01 |
| Consolidated HC Steam Sterilizer (K220736) | Consolidated Machine Corp. | 2022-08-01 |
| Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (K213929) | O&M Halyard, Inc. | 2022-08-01 |
| Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 (K221616) | Caf Medical Solutions, Inc. | 2022-08-01 |
| CellFX® System (K221671) | Pulse Biosciences, Inc. | 2022-08-01 |
| Disposable Medical Nitrile Examination Gloves (K220237) | Fujian Jixiang Medical Technology Co.,Ltd | 2022-08-01 |
| Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid (K221773) | Onetexx Sdn Bhd | 2022-07-30 |
| OptiVu ROSA MxR (K220733) | Orthosoft Inc (D/B/A Zimmer Cas) | 2022-07-29 |
| Next Generation NetKonnect (K220989) | Nihon Kohden Digital Health Solutions, Inc. | 2022-07-29 |
| RhinAer® Stylus (FG1393) (K221907) | Aerin Medical, Inc. | 2022-07-29 |
| Auxilock Titanium Screw-In Suture Anchor (K213104) | Auxein Medical Private Limited | 2022-07-29 |
| DiviTum TKa (K202852) | Biovica International AB | 2022-07-29 |
| Medispine - Spinal Needle, Glospine - Spinal Needle (K212982) | Global Medikit Limited | 2022-07-29 |