| K222987 — Akunah REFLECT | Akunah Pty, Ltd. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220437 — Neurophet AQUA | Neurophet., Inc. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231338 — 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221127 — Sientra, inc. Portfinder | Sientra, Inc. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223318 — Internal Joint Stabilizer - Elbow | Skeletal Dynamics, Inc. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223044 — Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223624 — Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231032 — AMP by Method Mobility, AMP Plus (or +) by Method Mobility | Method Mobility Wed May 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223825 — Tens & Ems Device | Shenzhen Jian Feng Electronic Technology Co., Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222436 — Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223015 — STERLINK FPS-15s Plus sterilizer with STERPACK plus cassette | Plasmapp Co,., Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223025 — Tyvek Roll with CI for STERLINK Sterilizer | Plasmapp Co,., Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222484 — Retitrack | C. Light Technologies, Inc. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K212857 — Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use | Jiangsu Zhiyu Medical Instrument Co, Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223655 — Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230721 — ATEC Lateral Plate System | Alphatec Spine, Inc. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223335 — SIRION Lateral Lumbar Interbody System | Astura Medical Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220083 — Stanza | Swing Therapeutics, Inc. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222719 — CX50N | Wide Corporation Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223023 — Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) | Plasmapp Co,., Ltd. Tue May 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222716 — MX50N | Wide Corporation Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223280 — Disposible Nitrile Gloves | Holik Asia Group Co.,Ltd Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222487 — Anika Tissue Tack Fixation System | Anika Therapeutics, Inc. Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223428 — Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) | Shenzhen Leqing Medical Instrument Co., Ltd. Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230674 — JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 | CC Wellness, LLC Mon May 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | Ortho-Clinical Diagnostics, Inc. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230989 — Rod Registration Frame | Nu Vasive, Incorporated Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230616 — Polyguard and Polyshield Safety IV Catheters | Poly Medicure Limited Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231017 — Panther Fusion AdV/hMPV/RV Assay | Hologic, Inc. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222926 — Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 | Shenzhen Yuezhongxing Technology Co., Ltd. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223858 — Lexa MINI (RIS-303, RIS-305) | W&H Sterilization S.R.L. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators | Ortho-Clinical Diagnostics, Inc. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230615 — Electric Scooter (Model: S3312) | Guangdong Prestige Technology Co., Ltd. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221768 — Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230351 — LED Facial Mask | Shenzhen Sungpo Hi-Tech Electronic Co., Ltd. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230637 — Wattson temporary pacing guidewire (2250) | Vascular Solutions, LLC Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220781 — ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K202963 — ELEC Master, ELEC Master Dual | Mgnewton , Ltd. Fri May 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230531 — SOZO Pro | ImpediMed Limited Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220713 — Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230994 — Alinity i STAT High Sensitivity Troponin-I | Abbott Laboratories Diagnostics Division Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213280 — BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App | Bd Kiestra B.V. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222388 — swiftPro System | Emblation , Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223430 — ProLift Micro Expandable Spacer System | Life Spine, Inc. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221798 — Finger Pulse Oximeter, Model: X1906P | Shenzhen Changkun Technology Co., Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230340 — Lucas Plus | Amt Engineering Co., Ltd. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230619 — Hubly Electric Drill (H100) | Hubly, Inc. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230082 — Auto Segmentation | Ge Medical Systems, LLC Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220290 — Revitalair 430+ | Us Hyperbaric Network Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230653 — Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates | Smith & Nephew, Inc. Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |