| MRI Planner (K211841) | Spectronic Medical AB | 2022-08-25 |
| CONDUIT Lateral Switch Plate (K221325) | Medos International SARL | 2022-08-25 |
| Apollo Duet (Model : APD-4000) (K212253) | Weero Co. | 2022-08-25 |
| ONX Large External Fixation System (K213905) | Orthonovis, Inc. | 2022-08-25 |
| Compass Steerable Needle (K221206) | Serpex Medical, Inc. | 2022-08-25 |
| Iconic Latex Glove (K221648) | Iconic Medicare Sdn Bhd | 2022-08-25 |
| LINQ II Insertable Cardiac Monitor (K221962) | Medtronic, Inc. | 2022-08-25 |
| V-Laser (K221427) | Wontech Co., Ltd. | 2022-08-24 |
| Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly (K222232) | Bard Access Systems, Inc. | 2022-08-24 |
| AutoContour Model RADAC V2 (K220598) | Radformation, Inc. | 2022-08-24 |
| Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (K220998) | Shenzhen Kentro Medical Electronics Co., Ltd. | 2022-08-24 |
| NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health (K222230) | Neuronetics, Inc. | 2022-08-24 |
| miCOR System Lens Fragmentation System (K222236) | Carl Zeiss Meditec Cataract Technology, Inc. | 2022-08-24 |
| ARIX Small Fragment System (K221920) | Jeil Medical Corporation | 2022-08-24 |
| ivWatch Model 400 (K222212) | Ivwatch, LLC | 2022-08-24 |
| TightRail Guardian Motorized Dilator Sheath (K212784) | Spectranetics, Inc. | 2022-08-24 |
| The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask (K211771) | The Good Corporation | 2022-08-24 |
| ClearCheck Model RADCC V2 (K220583) | Radformation, Inc. | 2022-08-23 |
| OneTouch Delica Plus Lancing System (K221546) | Asahi Polyslider Co., Ltd. | 2022-08-23 |
| 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil (K222257) | Invivo Corporation (Business Trade Name: Philips) | 2022-08-23 |
| GMK 3D Metal Tibial Tray (K221850) | Medacta International S.A. | 2022-08-23 |
| Safety Insulin Syringes (K220061) | Berpu Medical Technology Co., Ltd. | 2022-08-23 |
| FIBERGRAFT Aeridyan Matrix Bone Graft Substitute (K213803) | Prosidyan, Inc. | 2022-08-23 |
| Disposable Medical Safety Hypodermic Needle (K220603) | Hantech Medical Device Co., Ltd. | 2022-08-23 |
| 2.1 x 255mm Drill, 22mm Stop (K213072) | Biomet Micofixation | 2022-08-23 |
| FONA XDC (K222274) | Fona S.R.L | 2022-08-23 |
| Picosecond Laser System (Model PS10-A and PS10-B) (K220268) | Beijing Adss Development Co., Ltd. | 2022-08-23 |
| Bifix Hybrid Abutment Cement (K220640) | Voco GmbH | 2022-08-23 |
| Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter (K221528) | Edwards Lifesciences, LLC | 2022-08-22 |
| SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter (K221832) | Cordis US Corp | 2022-08-22 |
| VPS Rhythm DLX Device with TipTracker Technology (K220363) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022-08-22 |
| Arthrex FiberTape and TigerTape Cerclage Sutures (K221485) | Arthrex, Inc. | 2022-08-22 |
| Powered Inflatable Tube Massager - SLIM UP DRAIN (K201730) | Foggiare Technologies, LLC | 2022-08-22 |
| SafetiHeel, MediHeel, Novaplus (K221604) | Nsp Tech Pte, Ltd. | 2022-08-22 |
| ClearCalc Model RADCA V2 (K220582) | Radformation, Inc. | 2022-08-22 |
| SurGuard3 Safety Hypodermic Needle (K212095) | Terumo Europe N.V. | 2022-08-22 |
| CUSA Clarity Ultrasonic Surgical Aspirator System (K221835) | Integra LifeSciences Corporation | 2022-08-22 |
| Auxilock Draw Tight Suture-Based Anchor (K213109) | Auxein Medical Private Limited | 2022-08-22 |
| Powder Free Latex Examination Glove, Non-Sterile (K211601) | Wrp Asia Pacific Sdn. Bhd. | 2022-08-22 |
| HS40 Diagnostic Ultrasound System (K221599) | Samsung Medison Co., Ltd. | 2022-08-22 |
| Percent Oxygen Sensors (K213933) | Careox, LLC | 2022-08-19 |
| SmartAdjust(TM) technology (K220394) | Insulet Corporation | 2022-08-19 |
| AXIR-CX (K213520) | Radisen Co., Ltd. | 2022-08-19 |
| BD MAX Enteric Parasite Panel (K220193) | Becton, Dickinson and Company | 2022-08-19 |
| uCerv Flux-C 3D Porous Titanium Cervical Interbody (K220696) | Ulrich Medical USA | 2022-08-19 |
| DynaClip® Bone Staple (K220812) | MedShape, Inc. | 2022-08-19 |
| REAL INTELLIGENCE CORI (K221224) | Blue Belt Technologies, Inc. | 2022-08-19 |
| prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848) | Centinel Spine, LLC | 2022-08-19 |
| Disposable Endoscope Injection Needle (K220292) | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 |
| FUJIFILM Ultrasonic Endoscope EG-740UT (K221238) | Fujifilm Corporation | 2022-08-19 |
| Stent Positioning Assistance System (SPAS) (K221917) | Seven Sons , Ltd. | 2022-08-19 |
| Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices (K212525) | Advcare Medical | 2022-08-19 |
| 1688 4K Camera System with Advanced Imaging Modality (K222130) | Stryker | 2022-08-19 |
| Bonvadis Topical Cream (K212554) | Stemcyte, Inc. | 2022-08-19 |
| Viramed Borrela All-In-One ViraChip Test Kit (K220016) | Viramed Biotech AG | 2022-08-19 |
| CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW (K203078) | Huizhou Tianchang Industrial Co., Ltd. | 2022-08-19 |
| SmartBolus Calculator (K222239) | Insulet Corporation | 2022-08-19 |
| Baby Gorilla®/Gorilla® Plating System (K222194) | Paragon 28, Inc. | 2022-08-19 |
| Lexa PLUS RIS-311 (K213758) | W&H Sterilization S.R.L. | 2022-08-19 |
| Cortera Spinal Fixation System (K221403) | Surgalign Spine Technologies | 2022-08-19 |
| Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 (K221023) | Spinal Simplicity, LLC | 2022-08-19 |
| MI View&GO (K222172) | Siemens Medical Solutions USA, Inc. | 2022-08-19 |
| OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 (K221824) | Cipher Surgical Limited | 2022-08-19 |
| Miro3D Wound Matrix (K221520) | Reprise Biomedical, Inc. | 2022-08-18 |
| GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) (K220647) | Vascular Solutions, LLC | 2022-08-18 |
| OR3O Dual Mobility System (K220959) | Smith & Nephew, Inc. | 2022-08-18 |
| EnSite X EP System (K221213) | Abbott | 2022-08-18 |
| Benchmark BMX96 Access System (K213390) | Penumbra, Inc. | 2022-08-18 |
| iClean Viral Transport System (VTM-RT kit) (K212856) | Huachenyang (Shenzhen) Technology Co. , Ltd. | 2022-08-18 |
| Bio-MEM Ti Reinforced Membrane (K210797) | B&Medi Co., Ltd. | 2022-08-18 |
| Jeesung Safety Syringe and Single Use Needles (K212518) | Jeesung Medical Co., Ltd. | 2022-08-18 |
| Sotair Device (K212905) | Safe Bvm Corporation | 2022-08-18 |
| Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS (K221353) | Qura S.R.L | 2022-08-18 |
| truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (K222272) | STERIS Corporation | 2022-08-18 |
| implaFit® hip stems (K210678) | Implantcast GmbH | 2022-08-17 |
| Disposable Brain Biopsy Needle 2.0 (K220897) | PAJUNK GmbH Medizintechnologie | 2022-08-17 |
| Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner (K220452) | Materialise NV | 2022-08-17 |
| WebCeph (K220903) | Assemblecircle Corp. | 2022-08-17 |
| Surgical Face Mask (HNFM0103) (K221838) | Shanghai Hua EN Industrial Co, Ltd. | 2022-08-17 |
| Cross Protection ResQ300 Plus Surgical Face Mask (K212273) | Cross Protection (M) Sdn Bhd | 2022-08-17 |
| TDM Lumbar Interbody Fusion Cage System (K221844) | Tdm Co., Ltd. | 2022-08-17 |
| Tetragraph Neuromuscular Transmission Monitor (K220530) | Senzime AB | 2022-08-17 |
| CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) (K221112) | Biosense Webster, Inc. | 2022-08-17 |
| Disposable Sterile Syringe, with/without needle;luer/luer-lock, Disposable insulin syringe, Disposable Hypodermic needle (K212033) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2022-08-17 |
| Disposable Blood Lancets (K220387) | Suzhou Kyuan Medical Apparatus Co., Ltd. | 2022-08-17 |
| syngo Application Software (VE21) (K220433) | Siemens Medical Solution USA, Inc. | 2022-08-16 |
| Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter (K221852) | Shockwave Medical, Inc. | 2022-08-16 |
| HemosIL ReadiPlasTin (K213426) | Instrumentation Laboratory CO | 2022-08-16 |
| G-CAM (K220329) | Graphenano Dental S.L. | 2022-08-16 |
| ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System (K221190) | Siemens Medical Solutions USA, Inc. | 2022-08-16 |
| Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution (K213937) | O&M Halyard, Inc. | 2022-08-16 |
| Clear Aligner (K213026) | Shenzhen Meiming Dentistry Technology Co., Ltd. | 2022-08-16 |
| FairFix Adjustable Button System (K222169) | Medacta International S.A. | 2022-08-16 |
| YUWELL Finger Pulse Oximeter (K212385) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2022-08-16 |
| FORUM (K213527) | Carl Zeiss Meditec, AG | 2022-08-15 |
| Her-2, ER, PR IHControls (K220163) | Boston Cell Standards, Inc. | 2022-08-15 |
| Recon Steerable Sheath (K221302) | Serpex Medical, Inc. | 2022-08-15 |
| da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments (K214095) | Intuitive Surgical, Inc. | 2022-08-15 |
| XLase Plus (K212790) | Biotec Italia, Srl | 2022-08-15 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |