| Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System (K203599) | Immuno Concepts, N.A. , Ltd. | 2023-05-26 |
| V-HYADASE (K222606) | Vitromed GmbH | 2023-05-26 |
| Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS (K231233) | Conformis, Inc. | 2023-05-26 |
| Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 (K230739) | Shenzhen Ionka Medical Technology Co., Ltd. | 2023-05-26 |
| Pre-Sure (K230044) | Lazarus 3D | 2023-05-26 |
| Sweden & Martina Surgical Trays (K222640) | Sweden & Martina S.P.A. | 2023-05-26 |
| Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (K213289) | Ansell Healthcare Products, LLC | 2023-05-26 |
| Dark Star Deformity Pedicle Screw System (K223096) | Republic Spine, LLC | 2023-05-26 |
| CORE 500 Digital Stethoscope (K230111) | Eko Devices, Inc. | 2023-05-26 |
| VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System (K230065) | Fiagon GmbH | 2023-05-26 |
| Diode Laser System (K230580) | Smedtrum Medical Technology Co., Ltd. | 2023-05-26 |
| BB 8 Sinus Dilation Kit (K230258) | Excelent, Inc. | 2023-05-25 |
| Soreal Press, Soreal CAD (K230259) | Shenzhen Up3D Technology Co., Ltd. | 2023-05-25 |
| Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite (K223491) | Ge Medical Systems, LLC | 2023-05-25 |
| STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) (K231169) | Plasmapp Co,., Ltd. | 2023-05-25 |
| Armis VeriCyn Wound Wash (K220759) | Armis Biopharma, Inc. | 2023-05-25 |
| Advanced LumFix Spinal Fixation System (K222229) | CG Bio Co., Ltd. | 2023-05-25 |
| Saranas Early Bird Bleed Monitoring System (K230273) | Saranas, Inc. | 2023-05-25 |
| KLS Martin LINOS Wrist System (K222624) | KLS-Martin L.P. | 2023-05-25 |
| Model 9160 VitaloQUB (K223818) | Vitalograph Ireland, Ltd. | 2023-05-25 |
| Dentis s-Clean SQ-SL Narrow Implant System (K230246) | Dentis Co., Ltd. | 2023-05-25 |
| ThermoTK (K213256) | Zimmer Medizinsysteme GmbH | 2023-05-25 |
| Genesis ACTIVE Implant System (K223814) | Keystone Dental, Inc. | 2023-05-25 |
| S-COMP Reform® POCT Navigation Instruments (K231229) | Precision Spine, Inc. | 2023-05-25 |
| Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle (K222852) | Nipro Medical Corporation | 2023-05-25 |
| Dental Desensitizer (K222891) | Guangzhou Beogene Biotech Co., Ltd. | 2023-05-25 |
| Stingray LP Catheter (K231176) | Boston Scientific | 2023-05-25 |
| CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System (K222311) | Circa Scientific, Inc. | 2023-05-25 |
| Reprieve by RegenesisTM (K223620) | Regenesis Biomedical, Inc. | 2023-05-24 |
| s-Clean Link Abutment Narrow (K230523) | Dentis Co., Ltd. | 2023-05-24 |
| General Cutting Straight (K230106) | Nakanishi, Inc. | 2023-05-24 |
| Oxymag - Transport and Emergency Ventilator (K221634) | Magnamed Tecnologia Medica S/A | 2023-05-24 |
| Avatar Medical Software V1 (K222035) | Avatar Medical | 2023-05-24 |
| SIMDA Abutment (K223663) | Simda Co., Ltd. | 2023-05-24 |
| coactiv+™ Antimicrobial Wound Gel (K223259) | Kane Biotech, Inc. | 2023-05-24 |
| Green Non Sterile Powder Free Nitrile Examination Gloves (K230564) | Central Medicare Sdn Bhd | 2023-05-23 |
| Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath (K230874) | Suzhou Endophix Co., Ltd. | 2023-05-23 |
| ROSA Hip System (K231162) | Orthosoft Inc (D/B/A Zimmer Cas) | 2023-05-23 |
| Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 (K230134) | Hubei Yjt Technology Co.,Ltd | 2023-05-23 |
| Ceribell Status Epilepticus Monitor (K223504) | Ceribell, Inc. | 2023-05-23 |
| uMR Omega (K230152) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-23 |
| ADAS 3D (K230803) | Adas3D Medical S.L. | 2023-05-23 |
| Genius AI Detection 2.0 with CC-MLO Correlation (K230096) | Hologic, Inc. | 2023-05-23 |
| ACTERA™ hip system (K231178) | Conformis, Inc. | 2023-05-23 |
| Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior cervical interbody fusion-ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) (K230708) | Gbs Commonwealth Co., Ltd. | 2023-05-22 |
| Laser Thermal Therapy Kit (K230460) | Elesta S.P.A | 2023-05-22 |
| 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) (K231464) | 3M Company, Unitek Orthodontic Products | 2023-05-22 |
| Hi-Bond Universal (K230465) | Mediclus Co., Ltd. | 2023-05-22 |
| Introducer Needle (K222705) | Youcare Technology Co.,Ltd. (Wuhan) | 2023-05-22 |
| TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) (K230443) | Jiangxi Royall Smart Technology Co., Ltd. | 2023-05-22 |
| Integrity™ Bone Staple Fixation System (K223860) | Anika Therapeutics, Inc. | 2023-05-22 |
| TrueBeam, TrueBeam STx, Edge, VitalBeam (K223839) | Varian Medical Systems, Inc. | 2023-05-22 |
| MixJect® Transfer Device (K230464) | West Pharma. Services IL, Ltd. | 2023-05-22 |
| Kodiak™ Dual Port Coaxial Introducer Kit (K230631) | Argon Medical Devices | 2023-05-22 |
| HELIOS 785 Pico (K230373) | Laseroptek Co., Ltd. | 2023-05-22 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K231168) | Imperative Care, Inc. | 2023-05-22 |
| PVC Hydrophilic Urethral Catheter (K220722) | Well Lead Medical Co., Ltd. | 2023-05-22 |
| Disposable Medical Mask (K222545) | Guangzhou Fuzelong Hygiene Material Co., Ltd. | 2023-05-19 |
| ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX) (K222703) | Moving Life, Ltd. | 2023-05-19 |
| iLet® Dosing Decision Software (K220916) | Beta Bionics, Inc. | 2023-05-19 |
| Klassic Knee Revision System (K230537) | Total Joint Othopedics, Inc. | 2023-05-19 |
| VirtuOst (K220402) | O.N. Diagnostics | 2023-05-19 |
| Ventana™ C Spinal System (K222833) | Spinal Elements, Inc. | 2023-05-19 |
| Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors (K220842) | Qura S.R.L | 2023-05-19 |
| aprevo® transforaminal lumbar interbody fusion device (K231140) | Carlsmed, Inc. | 2023-05-19 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (K230416) | Stryker | 2023-05-19 |
| Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (K231137) | Xenta Biomedical Science Co., Ltd. | 2023-05-19 |
| Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) | Abbott Laboratories | 2023-05-19 |
| Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W (K222979) | Microlife Intellectual Property GmbH | 2023-05-19 |
| SafeBreak® Vascular (K223486) | Lineus Medical | 2023-05-19 |
| iLet® ACE Pump (K223846) | Beta Bionics, Inc. | 2023-05-19 |
| Autoplaque (K212758) | Cedars-Sinai Medical Center: Aim | 2023-05-19 |
| Exactech® Alteon® Short Tapered Wedge (K221323) | Exactech, Inc. | 2023-05-19 |
| PrevisEA Device (K230769) | Entac Medical, Inc. | 2023-05-19 |
| GI Genius System 100 and GI Genius System 200 (K231143) | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 |
| Spencer Probe Depth Electrodes (K223269) | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| ComASP Cefiderocol 0.008-128 (K230479) | Liofilchem s.r.l. | 2023-05-18 |
| Restrata® MiniMatrix (K223725) | Acera Surgical, Inc. | 2023-05-18 |
| Single Use Bipolar Forceps (K230432) | Hg Innovations, Ltd. | 2023-05-18 |
| Single-Use Flexible Ureteroscope (K230200) | Hunan Vathin Medical Instrument Co., Ltd. | 2023-05-18 |
| 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (K222578) | 3M Company | 2023-05-18 |
| Claritag Advanced (K222356) | Dgi Technologies | 2023-05-18 |
| C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor (K230723) | Nanjing Jusha Display Technology Co., Ltd. | 2023-05-18 |
| OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter (K230453) | Boston Scientific Corporation | 2023-05-18 |
| I.V. Administration Set, I.V. Extension Set (K223645) | Bq Plus Medical Co., Ltd. | 2023-05-18 |
| Arthrex FiberTak Suture Anchor (K231113) | Arthrex, Inc. | 2023-05-18 |
| Endo Motor (K220829) | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 |
| uMR 570 (K230758) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-05-18 |
| B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027) | Brahms GmbH, Part of Thermo Fisher Scientific | 2023-05-18 |
| Anchor Bolts as Accessories to Depth Electrodes (K223276) | Ad-Tech Medical Instrument Corporation | 2023-05-18 |
| Assert-IQ™ Insertable Cardiac Monitor (K230286) | ABBOTT MEDICAL | 2023-05-17 |
| DeepX DermoSight Dermatoscope (K230448) | Deepx Health, LLC | 2023-05-17 |
| Radiation Planning Assistant (RPA) (K222728) | University of Texas, MD Anderson Cancer Center | 2023-05-17 |
| F&P Solo Mask Range (K223696) | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 |
| Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) (K223437) | Hartalega NGC Sdn. Bhd. | 2023-05-17 |
| Symbia Pro.specta VA20A Family (K231102) | Siemens Medical Solutions USA, Inc. | 2023-05-17 |
| JuggerKnot Soft Anchor (K231128) | Riverpoint Medical, LLC | 2023-05-17 |
| BlueCheck™ Caries Detection & Monitoring (K222560) | Incisive Technologies Pty, Ltd. | 2023-05-16 |
| VERSAJET Hydrosurgery System (III) (K220964) | Smith & Nephew Medical Limited | 2023-05-16 |