| Annalise Enterprise CXR Triage Pneumothorax (K213941) | Annalise-Ai | 2022-02-24 |
| StimRouter Neuromodulation System (K211965) | Bioness, Inc. | 2022-02-23 |
| ONE Male Condom (DEN210034) | Global Protection Corp. | 2022-02-23 |
| Trigon HA Wedge Fixation System (K220197) | Nvision Biomedical Technologies, Inc. | 2022-02-23 |
| SuperLine (K213599) | Dentium Co., Ltd. | 2022-02-23 |
| EzOrtho v1.3 (K220003) | Ewoosoft Co., Ltd. | 2022-02-23 |
| Arsenal Ankle Plating System (K212378) | Trilliant Surgical | 2022-02-23 |
| Sclerotherapy Needle (K212668) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 |
| LevaLap Laparoscopic Access Device (K212786) | Core Access Surgical Technologies, Inc. | 2022-02-23 |
| Glidewell Appliance Resin, Hard/Soft (K214102) | Prismatik Dentalcraft, Inc. | 2022-02-23 |
| NuVasive Reline Cervical System (K213654) | Nu Vasive, Incorporated | 2022-02-23 |
| PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture (K212380) | ETHICON, Inc. | 2022-02-22 |
| VALO X, VALO X Accessory Lenses (K220471) | Ultradent Products, Inc. | 2022-02-22 |
| Enbio S (K213991) | Enbio Group AG | 2022-02-22 |
| INLIANT Surgical Navigation System (K213392) | Navigate Surgical Technologies, Inc. | 2022-02-22 |
| Flexible Video-Choledo-Cysto-Ureteroscope System (K211686) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2022-02-22 |
| EndoArmor™ + Surgical Gown (K203548) | Boston Scientific Corporation | 2022-02-21 |
| TMG Nitrile Powder Free Examination Glove (K213500) | Thai Medical Glove Co., Ltd. | 2022-02-21 |
| Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy (K213548) | Mercator Medical (Thailand), Ltd. | 2022-02-21 |
| Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange (K220232) | Megine Industries Sdn Bhd | 2022-02-20 |
| Medical Surgical Mask (K213724) | Hunan Zhenheyikang Medical Instrument Co., Ltd. | 2022-02-20 |
| Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (K214110) | Mah Sing Healthcare Sdn. Bhd. | 2022-02-19 |
| Powder Free Nitrile Examination Gloves (White, Blue and Black) (K212998) | Alcatron Gloves Factory | 2022-02-19 |
| Air Pressure Foot Massager (K212935) | Xiamen Simo Electronic Co., Ltd. | 2022-02-19 |
| Medical nitrile examination gloves (Model: SH001) (K213600) | Jiangxi Sanhao Medical Instruments Co.,Ltd | 2022-02-19 |
| Disposable Medical Nitrile Examination Gloves (K213912) | Jiangsu Maolin Medical Technology Co., Ltd. | 2022-02-19 |
| Surgical Face Mask (K212863) | Taiwan Comfort Champ Manufacturing Co., Ltd. | 2022-02-19 |
| Heartland Health Surgical Mask (K212366) | Heartland Health Products | 2022-02-19 |
| EONS Nitrile Examination Gloves Powder Free (K213286) | Eons Gloves (Thailand) Co., Ltd. | 2022-02-19 |
| Well-Life TENS/EMS/Heating Stimulator (K213091) | Well-Life Healthcare Limited | 2022-02-19 |
| Pocket Ultrasound System (K211746) | Guangdong Youkey Medical Co., Ltd. | 2022-02-18 |
| Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs (K213306) | Zibo Sinocare Plastic Products Co., Ltd. | 2022-02-18 |
| Deep Learning Image Reconstruction (K213999) | Ge Medical Systems, LLC | 2022-02-18 |
| Nitrile Examination Gloves (Model: ZMG1351) (K213688) | Wuhan Zonsen Medical Products Co., Ltd. | 2022-02-18 |
| Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs (K213440) | Luliang Hongruida Health Protection Technology Co., Ltd. | 2022-02-18 |
| Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria (K220162) | Hycor Biomedical | 2022-02-18 |
| ExamVue Duo (K213057) | Jpi Healthcare Co, Ltd. | 2022-02-18 |
| SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream (K212447) | Hangzhou Sejoy Electronics & Instruments Co., Ltd. | 2022-02-18 |
| Ear Thermometer, Model ET001 (K213079) | Guangzhou Berrcom Medical Device Co., Ltd. | 2022-02-18 |
| Viz ANEURYSM, Viz ANX (K213319) | Viz. Ai, Inc. | 2022-02-18 |
| True Tulip, True M.I.S. (K212627) | Innovative Surgical Designs, Inc. | 2022-02-18 |
| Traufix osteosynthesis, osteotomy, and arthrodesis devices (K201510) | Fixier S.A. DE C.V. | 2022-02-18 |
| Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E (K213503) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-02-18 |
| Acetaminophen (K202644) | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 |
| Multitom Rax with True2scale Body Scan Option (K212212) | Siemens Medical Solutions | 2022-02-18 |
| Zirconia Dental Ceramics (K214005) | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2022-02-18 |
| Dental Zirconia Pre-shaded Block (K214003) | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2022-02-18 |
| Vinyl/Nitrile Blend Exam Glove (K213634) | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-02-18 |
| Titan Condoms (K210208) | Titan Condoms, LLC | 2022-02-17 |
| Bluezone Model RX-450 Air Purifier (K212824) | Bluezone Products, Inc. | 2022-02-17 |
| SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands (K212977) | Cordis Corporation | 2022-02-17 |
| da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System (K213710) | Intuitive Surgical, Inc. | 2022-02-17 |
| Accu-Chek Softclix Blood Lancing System (K214022) | Roche Diabetes Care, Inc. | 2022-02-17 |
| Vinyl Examination Gloves (K213625) | Dezhou Hengchang Medical Technology Co., Ltd. | 2022-02-17 |
| Safety Pen Needle (K210864) | Sandstone Medical (Suzhou), Inc. | 2022-02-17 |
| Powder Free Blue Nitrile Examination Gloves (K213107) | Novid Ppe Sdn. Bhd. | 2022-02-17 |
| Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX (K213972) | Ge Healthcare Information Technologies, Inc. | 2022-02-17 |
| Durex Patronus Wide (K213647) | Rb Health (Us), LLC | 2022-02-17 |
| LoFric Elle (K211212) | Dentsply Sirona | 2022-02-17 |
| Amazing+ (K212586) | Amazing Rubber Products Pvt, Ltd. | 2022-02-17 |
| TENS & PMS (Model: SM9126) (K220150) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-02-17 |
| Voluson P6, Voluson P8 (K213689) | GE Healthcare | 2022-02-17 |
| YandR System, VoluDerm Handpiece, VoluDerm Tips (K220124) | Pollogen, Ltd. | 2022-02-17 |
| Lunderquist Extra Stiff Wire Guide (K220137) | William Cook Europe Aps | 2022-02-17 |
| Xtractor device (K211679) | Xcardia Innovation , Ltd. | 2022-02-17 |
| Digital Intraoral X-ray Sensor (K220277) | Shenzhen Xpectvision Technology Co., Ltd. | 2022-02-17 |
| Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires (K213982) | Pacific Instruments | 2022-02-17 |
| Treace Medical Concepts (TMC) Plating System (K220136) | Treace Medical Concepts, Inc. | 2022-02-16 |
| NovoFlow Reinforced Ureteral Stent (K213186) | Coloplast Corp. | 2022-02-16 |
| LumiVy Lumbar IBF System (K212930) | Vy Spine, LLC | 2022-02-16 |
| Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL (K213533) | Bio Compression Systems, Inc. | 2022-02-16 |
| Apapro Desensitizer (K220419) | Sangi Co., Ltd. | 2022-02-16 |
| Broncoflex Agile, Broncoflex Vortex, Screeni (K212886) | Axess Vision Technology | 2022-02-16 |
| Aspiron S ACP System (K220147) | U&I Corporation | 2022-02-16 |
| 14HQ901G-B (K214044) | Lg Electronics.Inc | 2022-02-16 |
| t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (K203234) | Tandem Diabetes Care, Inc. | 2022-02-15 |
| Sterile Auto-Disable Syringes with/without Needle for Single Use (K210229) | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-02-15 |
| Morpheus (K210636) | S4S UK , Ltd. | 2022-02-15 |
| EvoEndo Single-Use Endoscopy System (K213606) | EvoEndo, Inc. | 2022-02-14 |
| Fogarty Occlusion Catheter (K211610) | Edwards Lifesciences, LLC | 2022-02-14 |
| Vinyl Powder Free Examination Glove (K212011) | Top Glove Vietnam Company Limited | 2022-02-14 |
| Cionic Neural Sleeve NS-100 (K213622) | Cionic | 2022-02-14 |
| RithmID-SD Steerable Diagnostic Electrophysiology Catheter (K203793) | Synaptic Medical Corporation | 2022-02-14 |
| PainTB, PainTJ (K203337) | Ptech Co., Ltd. | 2022-02-11 |
| ArtUs (K211248) | Telemed | 2022-02-11 |
| ACUSON P500 Ultrasound System (K213487) | Siemens Medical Solutions USA, Inc. | 2022-02-11 |
| OsteoPlan System (K212570) | Osteomed, LLC | 2022-02-11 |
| IMICRYL Impression Materials (K213890) | Imicryl Dis Malzemeleri San. VE Tic. A.S. | 2022-02-11 |
| Electric Breast Pump (K211024) | Shantou Huihengqi Electronic Technology Co., Ltd. | 2022-02-11 |
| Actively Trying Personal Lubricant Rose Scented (K212885) | CC Wellness, LLC | 2022-02-11 |
| MAVERICK External Fixation System (K213874) | Smith & Nephew, Inc. | 2022-02-11 |
| Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System (K213328) | Stryker GmbH | 2022-02-11 |
| 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System (K211712) | Orthofix US, LLC | 2022-02-11 |
| Pulse Oximeter (K211400) | Beijing Choice Electronic Technology Co., Ltd. | 2022-02-11 |
| Zyter RPM (K212622) | Zyter, Inc. | 2022-02-11 |
| Wearable Breast Pump (Model S12) (K212180) | Shenzhen TPH Technology Co., Ltd. | 2022-02-11 |
| FlexitSystem Knee osteotomy system (K212545) | Neosteo | 2022-02-11 |
| EzRay M18 (Model: VMX-P400) (K213462) | VATECH Co., Ltd. | 2022-02-11 |
| SIGNA Artist Evo (K213603) | Ge Healthcare (Tianjin) Company Limited | 2022-02-11 |
| B. Braun Introcan Safety 2 IV Catheter (K213664) | B.Braun Medical, Inc. | 2022-02-11 |