| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (K214089) | Fujifilm Corporation | 2022-06-03 |
| Minjie Catheter System (K212288) | Kai Medtech, LLC | 2022-06-02 |
| Zavation eZspand Interbody System (K220581) | Zavation Medical Products, LLC | 2022-06-02 |
| Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (K220008) | Zoll Circulation, Inc. | 2022-06-02 |
| Q2 IV Administration Sets (K213588) | Quest Medical, Inc. | 2022-06-02 |
| EpilME (K213261) | Neauvia North America | 2022-06-02 |
| PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves (K220547) | O&M Halyard, Inc. | 2022-06-02 |
| IPL Hair Removal (K220927) | Shenzhen Qiaochengli Technology Co., Ltd. | 2022-06-02 |
| PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves (K220541) | O&M Halyard, Inc. | 2022-06-02 |
| Q Patch (K210758) | Medicalgorithmics S.A. | 2022-06-02 |
| Leaseir MHR Xcell (K214049) | Leaseir Technologies, Slu | 2022-06-02 |
| Boss Crossing Support Catheter (K220632) | Marvao Medical Devices, Ltd. | 2022-06-02 |
| Endoscopic Injection Needle (K213239) | Beijing Zksk Technology Co., Ltd. | 2022-06-02 |
| Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA (K220751) | Institut Straumann AG | 2022-06-02 |
| Restoris Multi-Compartmental Knee System (K220930) | Mako Surgical Corp. | 2022-06-02 |
| M6-C Artificial Cervical Disc Instruments AS (K220861) | Spinal Kinetics, LLC | 2022-06-02 |
| Hemosure Accu-Reader A100 (K200754) | W.H.P.M., Inc. | 2022-06-02 |
| Rayvolve (K220164) | Azmed Sas | 2022-06-02 |
| BeneVision Central Monitoring System (K220058) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-06-01 |
| 4CIS Chiron Spinal Fixation System (K203233) | Solco Biomedical Co., Ltd. | 2022-06-01 |
| CoreLink Navigation Instruments (K220973) | Corelink, LLC | 2022-06-01 |
| IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C (K221002) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2022-06-01 |
| Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System (K210107) | Genadyne Biotechnologies, Inc. | 2022-06-01 |
| freeflex+ Transfer Adapter (K212445) | Fresenius Kabi AG | 2022-06-01 |
| TriMed Ripcord Device (K220650) | TriMed, Inc. | 2022-06-01 |
| DeltaFil, DeltaFil Conditioner (K213201) | DMG Chemisch-Pharmazeutische Fabrik GmbH | 2022-06-01 |
| Purgo (K213753) | Aeroclean Technologies, LLC | 2022-06-01 |
| Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) (K220488) | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. | 2022-06-01 |
| FROG Forceps Valve (VAL1-F1-100) (K221264) | Fujifilm Medwork GmbH | 2022-06-01 |
| AneuGuide (K213838) | ArteryFlow Technology Co., Ltd. | 2022-06-01 |
| eMurmur Heart AI (K220766) | Csd Labs GmbH | 2022-05-31 |
| Distal Access Catheter (K213065) | Guangzhou Easycess Medical Co.,Ltd | 2022-05-31 |
| Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) (K220113) | Shenzhen Finicare Co., Ltd. | 2022-05-31 |
| Rapid LVO (K221248) | Ischemaview, Inc. | 2022-05-31 |
| Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit (K211571) | Zhejiang Longterm Medical Technology Co., Ltd. | 2022-05-31 |
| Respire Clear (K214096) | Respire Medical, LLC | 2022-05-31 |
| LuxCreo Clear Aligner System (K212680) | LuxCreo, Inc. | 2022-05-31 |
| Bone Cement-Normal Viscosity (K212729) | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda | 2022-05-31 |
| EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows (K213731) | Ever Fortune.Ai, Co., Ltd. | 2022-05-31 |
| IRRIGO Wound Wash Jet System (K210987) | Inopro, Inc. | 2022-05-31 |
| Liverty™ TIPS Access Set (K221440) | Bard Peripheral Vascular, Inc. | 2022-05-31 |
| Urea Nitrogen2 (K203771) | Abbott Ireland Diagnostics Division | 2022-05-31 |
| Fibrillar Collagen Wound Dressing (K213341) | Collagen Matrix, Inc. | 2022-05-31 |
| EchoNavigator R4.0 (K221270) | Philips Medical Systems Nederland B.V. | 2022-05-31 |
| Disposable Powder Free Polyethylene Examination Gloves (K212699) | Mastermax Plastic (Huizhou), Ltd. | 2022-05-31 |
| Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution (K213141) | Shen Wei USA, Inc. | 2022-05-28 |
| Blue Nitrile Examination Gloves Powder Free (K212584) | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 |
| Amazing+ Latex Examination Powder Free Gloves (K212597) | Amazing Rubber Products Pvt, Ltd. | 2022-05-28 |
| FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (K212268) | FMD Co., Ltd. | 2022-05-27 |
| MoistureMeterD Compact, LymphScanner (K220557) | Delfin Technologies, Ltd. | 2022-05-27 |
| Single Use Hemoclip (K212669) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-27 |
| Aspire Cristalle (K212873) | Fujifilm Corporation | 2022-05-27 |
| Spine Guidance Software, Stryker Q Guidance System (K220593) | Stryker Leibinger GmbH & Co KG | 2022-05-27 |
| Benchmark Intracranial Access System (K212838) | Penumbra, Inc. | 2022-05-27 |
| Navagio Lumbar Cage (K220902) | Kalitec Medical, LLC | 2022-05-27 |
| Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) (K220609) | Encompass Industries Sdn. Bhd. | 2022-05-27 |
| CoLink PCR Plating System (K213698) | In2bones USA, LLC | 2022-05-27 |
| VisAR (K220146) | Novarad Corporation | 2022-05-27 |
| Senhance Surgical System (K220889) | Asensus Surgical, Inc. | 2022-05-27 |
| SOLO-L (K220610) | Aurora Spine, Inc. | 2022-05-27 |
| Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs (K220545) | Hl Rubber Industries Sdn Bhd | 2022-05-26 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K212132) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| AMADEO, M-UK1015 (incl. attachments and accessories) (K213221) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 |
| iFuse Bedrock Granite™ Implant System (K220195) | SI-BONE, Inc. | 2022-05-26 |
| Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) (K213171) | Meditrina, Inc. | 2022-05-26 |
| PP Care Nitrile Examination Gloves (K212629) | Eg Group Product and Services Co., Ltd. | 2022-05-26 |
| Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) (K220249) | Grand Work Plastic Products Co., Ltd. | 2022-05-26 |
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |
| Disposable Surgical Face Mask (FM-34EE,FM-44EE) (K220597) | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 2022-05-26 |
| Aura Storm (K212644) | Invictus Lighting | 2022-05-26 |
| FreeStyle Libre 3 Continuous Glucose Monitoring System (K213996) | Abbott Diabetes Care, Inc. | 2022-05-26 |
| Amylase2 (K210633) | Abbott Ireland Diagnostics Division | 2022-05-26 |
| ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. (K211779) | Chip Ideas Electronics S.L. | 2022-05-26 |
| Wearable Breast Pump (Model S9) (K220596) | Shenzhen TPH Technology Co., Ltd. | 2022-05-26 |
| Laser Hair Growth Comb (K213027) | Kam Yuen Plastic Products , Ltd. | 2022-05-26 |
| I-Motion (K212413) | I-Motion Group Global Iberica S.L. | 2022-05-26 |
| Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs (K214074) | Hartalega NGC Sdn. Bhd. | 2022-05-26 |
| Astroglide Ultra Gentle Gel (K220355) | Biofilm, Inc. | 2022-05-26 |
| 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable (K214046) | Stryker | 2022-05-25 |
| SwiftMR (K220416) | Airs Medical, Inc. | 2022-05-25 |
| Single Use Ureteral Access Sheath (K220065) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 |
| OptiComp (K202920) | Pac-Dent, Inc. | 2022-05-25 |
| restor3d MTP Implant (K201393) | Restor3D, Inc. | 2022-05-25 |
| KardiaMobile 6L (K220350) | AliveCor, Inc. | 2022-05-25 |
| Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) (K220578) | Bozhou Rongjian Medical Appliance Co., Ltd. | 2022-05-25 |
| Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) (K220481) | Stryker Sustainability Solutions | 2022-05-25 |
| Micro-current facial cold and hot service (model: TPML-100) (K213039) | Li-Tek Electronics Technology C0., Ltd. | 2022-05-25 |
| CRYO Arctic, CRYO Penguin (K203661) | Cryoscience North America, Inc. | 2022-05-25 |
| Paltop Conical Implant System (K220200) | Paltop Advanced Dental Solutions, Ltd. | 2022-05-25 |
| Disposable Sterilized Latex Surgical Gloves (K211953) | Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. | 2022-05-25 |
| Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter (K210655) | Innovative Health, LLC | 2022-05-25 |
| Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments (K221180) | Medtronic Sofamor Danek USA, Inc. | 2022-05-25 |
| InnoVoyce Laser Fiber (K220793) | Innovoyce, LLC | 2022-05-25 |
| Renuvion Dermal Handpiece, Renuvion Dermal System (K211652) | Apyx Medical Corporation (Formerly Bovie Medical Corporation | 2022-05-25 |
| Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E (K213485) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-05-25 |
| LDV((Low Dead Volume )Syringe (K220083) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-05-25 |
| Well-life TM Pen Needles, Well-life TM Safety Pen Needles (K210748) | W. L. Med Co., Ltd. | 2022-05-25 |
| CD Horizon™ Spinal System (K221244) | Medtronic | 2022-05-25 |
| S-Line (K213191) | Barkey GmbH & Co. KG | 2022-05-24 |
| BENCOX Mirabo Z Cup Cortinium (K210614) | Corentec Co., Ltd. | 2022-05-24 |