| K230573 — Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230567 — OptiVu ROSA® MxR | Orthosoft Inc (D/B/A Zimmer Cas) Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K201153 — Tisuthes e-PTFE Surgical Patch | Shanghai Suokang Medical Implants Co., Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230112 — CAC Software | Imbio, Inc. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) | Bosungmeditech Co., Ltd. Tue Jun 13 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223669 — SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K221888 — Genadyne Hybrid Foam Dressings | Genadyne Biotechnologies, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230397 — Cut Screw - Percutaneous Compression Screw | GM Dos Reis Industria e Comercio Ltda. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231022 — Pounce Thrombectomy System | Surmodics,Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231466 — RxSight Insertion Device | Rxsight, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223078 — Atellica® CH Diazo Direct Bilirubin (D_DBil) | Siemens Healthcare Diagnostics, Inc. Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K213754 — SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S Mon Jun 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223361 — BMR 1900 PHISIO | Sorin Group Italia S.R.L. Sat Jun 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230992 — DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230586 — Renuvion® Micro Handpiece | Apyx Medical Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K220498 — NovoGen Wound Matrix | Novabone Products, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230512 — Gamma4 System | Stryker GmbH Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor | Edwards Lifesciences, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223091 — CT Perfusion V1.0 | Olea Medical Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231359 — RODIN Expandable Lumbar Cage System | Ctl Medical Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231347 — BruxZir TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230779 — Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Shanxi Hongjin Plastic Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| DEN220078 — Eroxon | Futura Medical Developments Limited Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222450 — LVIS NeuroMatch | LVIS Corporation Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230293 — TheraFace Mask | Therabody, Inc. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230905 — OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231037 — MyKnee UNI-ST | Medacta International S.A. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230892 — Fixone Biocomposite Anchor | Aju Pharm Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230744 — Acumed Acutrak 3 Headless Compression Screw System | Acumed, LLC Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230728 — JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor | Nanjing Jusha Display Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231368 — Bemer Therapy System Evo | Bemer Int AG Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230502 — Ear Pressure Relief Device(Model:ER813B) | Ningbo Albert Novosino Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230768 — M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230776 — Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) | Shenzhen Lutejiacheng Technology Co., Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230505 — Orthopantomograph OP 3D LX | Palodex Group OY Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230709 — Auryon Atherectomy System | Eximo Medical, Ltd. Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231042 — Disposable Laparoscopic Trocar | Changzhou Ankang Medical Instruments Co., Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230057 — Acumen Hypotension Prediction Index (HPI) Algorithm | Edwards Lifesciences, LLC Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222001 — Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe | Zhejiang Curaway Medical Technology Co., Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230008 — Ablamap® System | Ablacon, Inc. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231350 — OCD MT Cap (85-00397-000) | Neuronetics Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222792 — SNUCONE Tissue Level Implant System | Snucone Co., Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222684 — XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi | Stryker Spine Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230659 — Zionic Aesthetic | Termosalud Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K223918 — AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K230715 — Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K222762 — SIDDHARTH-II;IMPACT | Panacea Medical Technologies Pvt. , Ltd. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K214124 — AlloX2 Pro Tissue Expanders | Sientra, Inc. Thu Jun 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231360 — Ambra PACS | Dicom Grid Dba Ambra Health Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| K231002 — Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) | Suzhou Endophix Co., Ltd. Wed Jun 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |