| Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (K251212) | Access Vascular, Inc. | 2025-07-01 |
| SnugFit ASA Extension (K251933) | Medacta International S.A. | 2025-07-01 |
| Endoscopic Camera System (K250204) | Shenzhen Sophway Technology Co., Ltd. | 2025-07-01 |
| HeroTracker Sense (K250022) | Voluntis | 2025-06-30 |
| PIUR tUS inside (K250484) | Piur Imaging GmbH | 2025-06-30 |
| Otsuka Digital Feedback Device (K251088) | Otsuka America Pharmaceutical, Inc. | 2025-06-30 |
| EchoConfidence (USA) (K250670) | Mycardium AI Limited | 2025-06-30 |
| Synapse PACS (7.5) (K243647) | FUJIFILM Healthcare Americas Corporation | 2025-06-30 |
| aprevo® posterior/transforaminal lumbar interbody fusion device (K250987) | Carlsmed, Inc. | 2025-06-30 |
| Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) (K251000) | Shenzhen Chuangtong Yigou Technology Co., Ltd. | 2025-06-30 |
| The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990) | Thermo Fisher Scientific | 2025-06-30 |
| Primum Hydrophilic Guiding Catheter (K250972) | Pendracare | 2025-06-29 |
| USTOMED Bone Fixation/Bone Augmentation Systems - PIN (K243190) | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | 2025-06-27 |
| Luja Coudé (K251116) | Coloplast Corp. | 2025-06-27 |
| Maestro System (REF100) (K250984) | Moon Surgical | 2025-06-27 |
| Philips iCT CT system (K250648) | Philips Medical Systems Nederland B.V. | 2025-06-27 |
| Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610) | Sorin Group Italia S.R.L. | 2025-06-27 |
| FIX-C PEEK ACIF SA System (K251431) | Jeil Medical Corporation | 2025-06-27 |
| T3 Pro Implants– ZimVie Packaging System (K251660) | Biomet 3i, LLC | 2025-06-27 |
| Multi4 System (K250522) | Multi4 Medical AB | 2025-06-27 |
| Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) (K243187) | Cork Medical | 2025-06-27 |
| Disposable Distal Cap (K243388) | Micro-Tech (Nanjing) Co., Ltd. | 2025-06-27 |
| Affirm 800 (K243077) | Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) | 2025-06-27 |
| LumenaTM Ureteral Access Sheath (K250585) | Cathegenix (Xiamen) Co., Ltd. | 2025-06-27 |
| Genostis Osteosynthesis System (K242988) | Genostis AF | 2025-06-27 |
| SonoPlex STIM; SonoPlex II (K243682) | PAJUNK GmbH Medizintechnologie | 2025-06-27 |
| Diode laser device (RF3120-BI) (K251329) | Risu Medical Technology Co., Ltd. | 2025-06-27 |
| BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter (K251654) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-27 |
| JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (K250969) | Dent4you AG | 2025-06-27 |
| Integral Dental Unit (K243130) | Guangdong Yadeng Medical Apparatus Co., Ltd., | 2025-06-27 |
| CPS Locator 3D Plus Delivery Catheter (K250828) | CenterPoint Systems, LLC | 2025-06-27 |
| X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (K243144) | Scopio Labs , Ltd. | 2025-06-27 |
| Testa TP Pivoting Spacer System (K243816) | Spine Wave, Inc. | 2025-06-27 |
| RTMsense Respiratory Monitoring System (K243183) | Rtm Vital Signs, LLC | 2025-06-27 |
| Dental CBCT X-ray System (K251642) | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
| eMotus Respiratory Motion Management System (K243900) | Empnia, Inc. | 2025-06-27 |
| VIKING™ Fixed Curve Diagnostic Catheter (K250310) | Boston Scientific Corporation | 2025-06-27 |
| Ampa One System (AMPA-001) (K251210) | Neuromodulatory Devices & Applications | 2025-06-27 |
| Freedom® Total Knee System – Titanium Tibial Base Plate (K251717) | Maxx Orthopedics, Inc. | 2025-06-26 |
| Neuralytix iD3 System (NTX-9001) (K243636) | Neuralytix, LLC | 2025-06-26 |
| SwissGraft X (K251613) | Geistlich Pharma AG | 2025-06-26 |
| Optimas MAX System (K251632) | InMode , Ltd. | 2025-06-26 |
| Velacur One (LI-1100) (K251728) | Sonic Incytes Medical Corp | 2025-06-26 |
| The Rialto™ SI Fusion System (K251395) | Medtronic Sofamor Danek USA, Inc. | 2025-06-26 |
| AISight Dx (K243391) | PathAI, Inc. | 2025-06-26 |
| Doppler FHR Detector (BF-500D+, BF-560) (K242846) | Shenzhen Bestman Instrument Co., Ltd. | 2025-06-26 |
| HardyDisk AST Gepotidacin 10µg (GEP10) (K250956) | Hardy Diagnostics | 2025-06-26 |
| TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) (K250929) | TriMed, Inc. | 2025-06-26 |
| Lap.Ox™ Laparoscopic Tissue Oximeter (K250519) | ViOptix, Inc. | 2025-06-26 |
| Atmo Gas Capsule System (K250940) | Atmo Biosciences, Ltd. | 2025-06-26 |
| safety lancet (K251694) | Tianjin Huahong Technology Co., Ltd. | 2025-06-26 |
| Disposable Intermittent Catheter (TPU Catheter) (K243175) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2025-06-26 |
| Equinoxe® Scapula Fracture System (K243275) | Exactech, Inc. | 2025-06-26 |
| Sherlock (K250967) | Open Implants, LLC | 2025-06-26 |
| NeuroTrac® MyoPlus Pro (MYO120U) (K243079) | Verity Medical , Ltd. | 2025-06-26 |
| Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) (K250548) | Joytech Healthcare Co. , Ltd. | 2025-06-26 |
| Sterilization Pouch and Roll (K243179) | Yichang Xinxin Paper Products Co., Ltd. | 2025-06-26 |
| Sysmex XR-Series (XR-10) Automated Hematology Analyzer (K250943) | Sysmex America, Inc. | 2025-06-25 |
| X-PAC® LLIF Expandable Lateral Cage System (K251003) | Expanding Innovations, Inc. | 2025-06-25 |
| CORIOGRAPH Pre-Op Planning and Modeling Services (K250921) | Blue Belt Technologies, Inc. | 2025-06-25 |
| SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774) | PAJUNK GmbH Medizintechnologie | 2025-06-25 |
| GeniPhys Collymer Self-Assembling Scaffold (K250329) | Geniphys, Inc. | 2025-06-25 |
| Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| SAT CenterFlow Molding Balloon Catheter (IN20-00313) (K243184) | Strait Access Technologies Holdings | 2025-06-25 |
| Curapuls 670 (K243112) | Enraf-Nonius, B.V. | 2025-06-25 |
| Globe® Pulsed Field System (K250747) | Kardium, Inc. | 2025-06-25 |
| EGIS Biliary Double Bare Stent (BDB080405) (K242845) | S&G Biotech, Inc. | 2025-06-25 |
| CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) (K250966) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025-06-25 |
| Sysmex XR-Series (XR-20) Automated Hematology Analyzer (K251371) | Sysmex America, Inc. | 2025-06-25 |
| Power Wheelchair (D26) (K251606) | Anhui Jbh Medical Apparatus Co., Ltd. | 2025-06-25 |
| ANAX™ OCT Spinal System (K251725) | Cg Medtech Co., Ltd. | 2025-06-25 |
| Flexible Partial Resin (K250302) | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue) (K251627) | Smith & Nephew, Inc. | 2025-06-25 |
| PediFlex™ Flexible Nail System (K251362) | OrthoPediatrics Corp. | 2025-06-24 |
| GPS Advanced; GPS Advanced Cannula (K251648) | Prosidyan, Inc. | 2025-06-24 |
| Bridge Plus Occlusion Balloon (590-002) (K251358) | Philips Image Guided Therapy Devices | 2025-06-24 |
| MIST IC (K243009) | Imagine Milling Technologies, LLC | 2025-06-24 |
| HyperSnap Surgical System (HSS) (K250268) | Hypervision Surgical | 2025-06-24 |
| Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) (K250326) | Spectrum Medical S.R.L. | 2025-06-24 |
| ProAM ALIF System (K251644) | Pro Surgical, Inc. | 2025-06-24 |
| Cranial 4Pi Immobilization (K243142) | Brainlab AG | 2025-06-23 |
| OPXION Optical Skin Viewer (OPXSV1-01F) (K242924) | Opxion Technology, Inc. | 2025-06-23 |
| TempFIT Temporary Crown and Bridge Resin (K251271) | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103) (K250470) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-06-23 |
| EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-P190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XT190); BRONCHOVIDEOSCOPE (OLYMPUS BF-H1100); BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH1100) (K250862) | Olympus Medical Systems Corp. | 2025-06-23 |
| Ceftobiprole BPR 5 µg Disc (K250885) | Liofilchem, Inc. | 2025-06-23 |
| WiTOF (K243339) | Idmed | 2025-06-23 |
| Digital Prism Correction Feature (DPCF) (K250143) | Apple, Inc. | 2025-06-23 |
| Hippocampe Marathon and Trail (K251570) | Vipamat Sarl | 2025-06-23 |
| Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106) (K243000) | Shenzhen Medke Technology Co., Ltd. | 2025-06-20 |
| FUBUKI XF-R Neurovascular Long Sheath (K251560) | Asahi Intecc Co., Ltd. | 2025-06-20 |
| BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232); BD Intelliport Mount (516233); BD Intelliport Charger (516231) (K243062) | Becton Dickinson | 2025-06-20 |
| ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) (K251248) | Jinhua Qidian Vehicle Co., Ltd. | 2025-06-20 |
| Us2.ca (K250151) | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025-06-20 |
| Atellica IM Thyroglobulin (Tg) (K242981) | Siemens Healthcare Diagnostics, Inc. | 2025-06-20 |
| NovoSorb BTM (K251567) | Polynovo Biomaterials Pty, Ltd. | 2025-06-20 |
| Branchor X Balloon Guide Catheter (K251240) | Asahi Intecc Co., Ltd. | 2025-06-20 |
| Celsi Warmer (K242964) | Hadleigh Health Technologies | 2025-06-20 |
| Incompass Total Ankle System (K250037) | Wright Medical Technology, Inc. (Stryker) | 2025-06-20 |
| LED Facial Mask (K243978) | Shenzhen Sunsred Technology Co.,Ltd | 2025-06-20 |