| Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 (K250789) | Thermo Fisher Scientific (Oxoid Ltd.) | 2025-06-12 |
| Fractional CO2 Laser Machine (K250782) | Zhengzhou PZ Laser Slim Technology Co., Ltd. | 2025-06-12 |
| Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865) | Biocomposites, Ltd. | 2025-06-12 |
| Second Opinion® CS (K243234) | Pearl, Inc. | 2025-06-12 |
| APO-Easy Genotyping kit (DEN240032) | Firalis SA | 2025-06-12 |
| Rezum System (K250584) | Boston Scientific Corporation | 2025-06-11 |
| LORRAINE 2.5/3.5mm Distal Humerus System (K250933) | Bonebridge AG | 2025-06-11 |
| Self-Forming Magnet (Flexagon) (K243482) | GI Windows, Inc. | 2025-06-11 |
| da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000) (K240852) | Intuitive Surgical, Inc. | 2025-06-11 |
| MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) (K242801) | Carl Zeiss Meditec Cataract Technology, Inc. | 2025-06-11 |
| Liberant Thrombectomy System (K250787) | Medtronic, Ireland | 2025-06-11 |
| Impact PEEK Union Nail System (K250646) | Nvision Biomedical Technologies | 2025-06-11 |
| Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) (K250269) | Ambu A/S | 2025-06-11 |
| Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499) | William Cook Europe Aps | 2025-06-11 |
| Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710) | Enpuno Co., Ltd. | 2025-06-11 |
| 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921) | Vitaltec Corporation | 2025-06-10 |
| TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956) | Nihon Kohden Corporation | 2025-06-10 |
| EXTRON 3; EXTRON 5; EXTRON 7 (K250010) | DRTECH Corporation | 2025-06-10 |
| Viz Subdural+, Viz SUBDURAL PLUS (K250354) | Viz. Ai, Inc. | 2025-06-10 |
| Elecsys Anti-SARS-CoV-2 (K250768) | Roche Diagnostics | 2025-06-10 |
| FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP (K243512) | Fujifilm Corporation | 2025-06-10 |
| EndyMed PRO MAX (K242996) | Endymed Medical, Ltd. | 2025-06-10 |
| Dental Barrier and Sleeves (K250735) | Fomed Industries, Inc. | 2025-06-10 |
| Bonvadis® (K251093) | Oneness Biotech Co., Ltd. | 2025-06-09 |
| CO2 Laser Machine (Lume) (K250465) | Nanjing Bestview Laser S&T Co., Ltd. | 2025-06-09 |
| LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) (K250830) | Shenzhen Sungrow Led Technology Co., Ltd. | 2025-06-09 |
| MallyaG Injection Pen Adapter (MallyaG) (K251500) | Biocorp Production | 2025-06-09 |
| Magnetic Surgical System (K250746) | Levita Magnetics International Corp | 2025-06-07 |
| Discovery Pico; Discovery Pico Plus; Discovery Pico Derm (K240983) | Quanta System Spa | 2025-06-06 |
| ONVOY™ Acetabular System (K243456) | Globus Medical, Inc. | 2025-06-06 |
| Cirrus Resting State fMRI Software (K251009) | Sora Neuroscience, Inc. | 2025-06-06 |
| Light Therapy System (M500, L6) (K251042) | Guangzhou Ahead Intelligent Technology Co., Ltd. | 2025-06-06 |
| Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) (K251450) | Shenzhen Desida Technology Co., Ltd. | 2025-06-06 |
| Steam Sterilizer (2545D) (K243994) | Ningbo Ican Machines Co., Ltd. | 2025-06-06 |
| Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045) (K251452) | Steris | 2025-06-06 |
| Geister K-Rex rongeurs (K242759) | Geister Medizin Technik GmbH | 2025-06-06 |
| Omnia Medical PsiF DNA™ System (K242431) | Omnia Medical, LLC | 2025-06-06 |
| SpydrBlade Flex Instrument (PRD-RG1-001) (K242774) | Creo Medical, Ltd. | 2025-06-06 |
| TYBR Collagen Gel (K250109) | Tybr Health | 2025-06-06 |
| Anovo Surgical System (6Ne) (K250591) | Momentis Surgical , Ltd. | 2025-06-06 |
| KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) (K243550) | Karl Storz SE & CO. KG | 2025-06-06 |
| SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (K251525) | Si-Technology, LLC | 2025-06-06 |
| DELPHI System (K242907) | CnS Medical Co., Ltd. | 2025-06-06 |
| GCI Sterilization Wrappers (K250321) | George Courey, Inc. | 2025-06-06 |
| Nd: YAG Laser Therapy System (QN-1) (K250722) | Hebei JT Medical Co., Ltd. | 2025-06-06 |
| Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue (K243694) | Mah Sing Healthcare Sdn. Bhd. | 2025-06-06 |
| Once-Fil Flow (K251283) | Mediclus Co., Ltd. | 2025-06-06 |
| Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal (K242737) | Empatica S.r.l. | 2025-06-06 |
| Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C (K250891) | Convatec Limited | 2025-06-06 |
| Annex® 2 Adjacent Level System (K251131) | Spine Wave, Inc. | 2025-06-06 |
| LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) | Luminex Corporation | 2025-06-06 |
| MBA Biotech Implant System (K243002) | MBA Biotech Co., Ltd. | 2025-06-06 |
| Portable Oxygen Concentrator (Spirit-3) (K242736) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 |
| Synchrony (20-3000) (K242704) | Synapse Biomedical, Inc. | 2025-06-05 |
| TechLive (K243703) | DeepHealth, Inc. | 2025-06-05 |
| Trinity EVO Acetabular Shell (K242744) | Corin U.S.A. Limited | 2025-06-05 |
| UroNav 4 (K250800) | Philips DS North America, LLC | 2025-06-05 |
| Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (K250545) | Surgical Instrument Service and Savings, Inc. | 2025-06-05 |
| Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) (K250701) | Olympus Medical Systems Corp. | 2025-06-05 |
| Stealth™ Spine Clamps; ModuLeX™ Shank Mounts (K242464) | Medtronic Navigation, Inc. | 2025-06-05 |
| Red Light Hair Growth Cap (LP-RJVGRW-BLK) (K250467) | Shenzhen Idea Light Limited | 2025-06-05 |
| Portare System (FA-001) (K243639) | Grumpy Innovation, Inc. | 2025-06-05 |
| BrightHeart View Classifier (K251456) | Brightheart | 2025-06-05 |
| zirkon; structure; LFU shades, stains and glazes (K251084) | Estetic Ceram AG | 2025-06-05 |
| Sonic DL (K243667) | Ge Medical Systems, LLC | 2025-06-05 |
| Central Station (K242750) | Nihon Kohden Digital Health Solutions, LLC | 2025-06-05 |
| Clave™ Neutral-Displacement Needlefree Connectors (K250616) | Icu Medical, Inc. | 2025-06-05 |
| Montblanc Plate System (K243368) | Medifield Medical Co., Ltd. | 2025-06-04 |
| Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (K251433) | Surgify Medical OY | 2025-06-04 |
| Ultrasound Stimulator (K240788) | Jkh Health Co., Ltd. | 2025-06-04 |
| Tendon Protect (50242) (K243843) | Kerecis Limited | 2025-06-04 |
| Paradigm System (K250879) | Proprio, Inc. | 2025-06-04 |
| LubriZenzs (K242712) | Sk Zen, LLC | 2025-06-04 |
| Blood collection tube holders (K250961) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| EVE Synergy (EVE-20M) (K241433) | Weero Co., Ltd. | 2025-06-04 |
| PhysCade System (K250749) | Physcade, Inc. | 2025-06-04 |
| NG-Test® CTX-M MULTI (K243499) | Ng Biotech | 2025-06-04 |
| Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System (K251397) | Philips Medical Systems Nederland B.V. | 2025-06-04 |
| ID LIGHT CURE SYSTEM (K250804) | Id Korea Co., Ltd. | 2025-06-04 |
| TraumaCad Neo (1.1) (K243810) | Brainlab , Ltd. | 2025-06-04 |
| Disposable Balloon Catheter B5-2C (K250118) | Olympus Medical Systems Corporation | 2025-06-04 |
| TeleRehab Aermos Cardiopulmonary Rehabilitation (K250259) | The ScottCare Corporation | 2025-06-04 |
| 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216) | Barbaras Development, Inc. | 2025-06-04 |
| Raptor Aspiration Catheter; Balt Aspiration Tubing Set (K243948) | Balt USA, LLC | 2025-06-03 |
| gi2000 Electrosurgical Generator (K250657) | Cintron Medical Corporation | 2025-06-03 |
| GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] (K243796) | Glove One, LLC | 2025-06-03 |
| RZ Resectoscope System (K243382) | Rz Medizintechnik GmbH | 2025-06-03 |
| DISINTEK™ PA Test Strips (K251035) | Serim Research | 2025-06-03 |
| Patriot SI Implant System (K250001) | Spinal Simplicity, LLC | 2025-06-03 |
| EVAC (K243205) | Phasor Health, LLC | 2025-06-03 |
| PENTAX Medical Video Processor (EPK-i8020c) (K251127) | Pentax of America, Inc. | 2025-06-03 |
| Endoform Reconstructive Template - PLGA (K250598) | Aroa Biosurgery , Ltd. | 2025-06-03 |
| Partial Flex (K242897) | Clemde SA DE CV | 2025-06-03 |
| BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K250682) | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-06-03 |
| Globe Introducer (601-01001) (K250529) | Kardium, Inc. | 2025-06-03 |
| Tera Lumbar Interbody Fusion System (Various PNs) (K251335) | Acuity Surgical Devices, LLC | 2025-06-02 |
| PULLUP®; PULLUP® CLIP; BT LOOP®; PULLUP® TEX CLIP; RIGIDLOOP™ T; RIGIDLOOP™ Clip; RIGIDLOOP™ BTB; RIGIDLOOP™ Suture Loop (K250844) | Science & Bio Materials (S.B.M.) Sas | 2025-06-02 |
| CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) (K250452) | MacroLux Medical Technology Co., Ltd. | 2025-06-02 |
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| Automated Blood Coagulation Analyzer CN-Series (CN-6000) (K250965) | Sysmex America, Inc. | 2025-06-02 |