| K211046 — eCareManager 4.5 | Visicu, Inc. Jun 3, 2022 |
| K220861 — M6-C Artificial Cervical Disc Instruments AS | Spinal Kinetics, LLC Jun 2, 2022 |
| K220164 — Rayvolve | Azmed Sas Jun 2, 2022 |
| K210758 — Q Patch | Medicalgorithmics S.A. Jun 2, 2022 |
| K220581 — Zavation eZspand Interbody System | Zavation Medical Products, LLC Jun 2, 2022 |
| K212288 — Minjie Catheter System | Kai Medtech, LLC Jun 2, 2022 |
| K220008 — 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 | Zoll Circulation, Inc. Jun 2, 2022 |
| K220541 — PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. Jun 2, 2022 |
| K220632 — Boss Crossing Support Catheter | Marvao Medical Devices, Ltd. Jun 2, 2022 |
| K220751 — Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG Jun 2, 2022 |
| K220927 — IPL Hair Removal | Shenzhen Qiaochengli Technology Co., Ltd. Jun 2, 2022 |
| K213239 — Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. Jun 2, 2022 |
| K220547 — PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. Jun 2, 2022 |
| K220930 — Restoris Multi-Compartmental Knee System | Mako Surgical Corp. Jun 2, 2022 |
| K213588 — Q2 IV Administration Sets | Quest Medical, Inc. Jun 2, 2022 |
| K213261 — EpilME | Neauvia North America Jun 2, 2022 |
| K214049 — Leaseir MHR Xcell | Leaseir Technologies, Slu Jun 2, 2022 |
| K200754 — Hemosure Accu-Reader A100 | W.H.P.M., Inc. Jun 2, 2022 |
| K220488 — Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) | Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. Jun 1, 2022 |
| K210107 — Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. Jun 1, 2022 |
| K213201 — DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH Jun 1, 2022 |
| K213753 — Purgo | Aeroclean Technologies, LLC Jun 1, 2022 |
| K212445 — freeflex+ Transfer Adapter | Fresenius Kabi AG Jun 1, 2022 |
| K220058 — BeneVision Central Monitoring System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Jun 1, 2022 |
| K221002 — IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C | Shenzhen Ulike Smart Electronics Co., Ltd. Jun 1, 2022 |
| K221264 — FROG Forceps Valve (VAL1-F1-100) | Fujifilm Medwork GmbH Jun 1, 2022 |
| K203233 — 4CIS Chiron Spinal Fixation System | Solco Biomedical Co., Ltd. Jun 1, 2022 |
| K220973 — CoreLink Navigation Instruments | Corelink, LLC Jun 1, 2022 |
| K213838 — AneuGuide | ArteryFlow Technology Co., Ltd. Jun 1, 2022 |
| K220650 — TriMed Ripcord Device | TriMed, Inc. Jun 1, 2022 |
| K220113 — Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) | Shenzhen Finicare Co., Ltd. May 31, 2022 |
| K213731 — EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows | Ever Fortune.Ai, Co., Ltd. May 31, 2022 |
| K212729 — Bone Cement-Normal Viscosity | Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda May 31, 2022 |
| K212699 — Disposable Powder Free Polyethylene Examination Gloves | Mastermax Plastic (Huizhou), Ltd. May 31, 2022 |
| K221440 — Liverty TIPS Access Set | Bard Peripheral Vascular, Inc. May 31, 2022 |
| K203771 — Urea Nitrogen2 | Abbott Ireland Diagnostics Division May 31, 2022 |
| K213341 — Fibrillar Collagen Wound Dressing | Collagen Matrix, Inc. May 31, 2022 |
| K212680 — LuxCreo Clear Aligner System | LuxCreo, Inc. May 31, 2022 |
| K213065 — Distal Access Catheter | Guangzhou Easycess Medical Co.,Ltd May 31, 2022 |
| K220766 — eMurmur Heart AI | Csd Labs GmbH May 31, 2022 |
| K211571 — Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit | Zhejiang Longterm Medical Technology Co., Ltd. May 31, 2022 |
| K221248 — Rapid LVO | Ischemaview, Inc. May 31, 2022 |
| K210987 — IRRIGO Wound Wash Jet System | Inopro, Inc. May 31, 2022 |
| K214096 — Respire Clear | Respire Medical, LLC May 31, 2022 |
| K221270 — EchoNavigator R4.0 | Philips Medical Systems Nederland B.V. May 31, 2022 |
| K213141 — 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 | Shen Wei USA, Inc. May 28, 2022 |
| K212584 — Blue Nitrile Examination Gloves Powder Free | Amazing Rubber Products Pvt, Ltd. May 28, 2022 |
| K212597 — Amazing+ Latex Examination Powder Free Gloves | Amazing Rubber Products Pvt, Ltd. May 28, 2022 |
| K220609 — Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) | Encompass Industries Sdn. Bhd. May 27, 2022 |
| K212838 — Benchmark Intracranial Access System | Penumbra, Inc. May 27, 2022 |