| Picosecond Nd:YAG Laser System; PICO LEGEND (K233007) | Ami, Inc. | 2024-06-12 |
| EO Chex Indicator Tape (K240910) | Propper Manufacturing Co., Inc. | 2024-06-12 |
| Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) (K241352) | Medtronic, Inc. | 2024-06-12 |
| Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (K232950) | Perfect Medical Industry (Vn) Co., Ltd. | 2024-06-12 |
| PLASMA EDGE System (K240504) | Lamidey Noury Medical | 2024-06-12 |
| MEDIBLU ECG SYSTEM (K233266) | Mediblu Medical, LLC | 2024-06-12 |
| ACUSON P500 Ultrasound System; ACUSON P500 ICE Ultrasound System (K233610) | Siemens Medical Solutions USA, Inc. | 2024-06-12 |
| SOUNDSTAR™ CRYSTAL Ultrasound Catheter (K240050) | Biosense Webster, Inc. | 2024-06-12 |
| MetriCide™ OPA Plus Solution Test Strip (K241344) | Steris | 2024-06-11 |
| Mi-CHORD System (DEN230069) | Lsi Solutions, Inc. | 2024-06-11 |
| JADE PLUS PTA Balloon Dilatation Catheter (K241025) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 |
| Mako Total Knee Application (K241011) | Mako Surgical Corp. | 2024-06-11 |
| InActiv Blue (K221547) | Fertipro NV | 2024-06-11 |
| SIGNEX (K230546) | Osteonic Co., Ltd. | 2024-06-11 |
| DOOPANG (K232749) | Ybrain, Inc. | 2024-06-11 |
| Venue (K240111) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| Venue Go (K240053) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| Indigo® Lightning Flash Aspiration System – Select +™ Catheter (K241399) | Penumbra, Inc. | 2024-06-10 |
| Histofreezer V (K240106) | Cryoconcepts LP | 2024-06-10 |
| Venue Sprint (K240206) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) (K240283) | MacroLux Medical Technology Co., Ltd. | 2024-06-10 |
| Medical Diode Laser (S1Pro) (K240644) | Wuhan Pioon Technology Co., Ltd. | 2024-06-10 |
| KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) (K232911) | Karl Storz Endovision, Inc. | 2024-06-10 |
| OmniTom Elite (K233767) | Neurologica Corporation | 2024-06-10 |
| Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01) (K240108) | Gymmax Technology Shenzhen Co., Ltd. | 2024-06-10 |
| Venue Fit (K234106) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2024-06-10 |
| iLoop Interventional Coil 0.55T (K241069) | Noras Mri Products GmbH | 2024-06-07 |
| Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) (K240672) | Zhejiang Zahndent Biotechnology Co., Ltd. | 2024-06-07 |
| EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) (K234042) | Ever Fortune.Ai, Co., Ltd. | 2024-06-07 |
| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) (K232963) | bioMerieux, Inc. | 2024-06-07 |
| Blood Pressure Monitor (BBZ32-AA01) (K240832) | Guangdong Transtek Medical Electronics Co., Ltd. | 2024-06-07 |
| Cardiac CT Function Software Application (K241038) | Circle Cardiovascular Imaging | 2024-06-07 |
| Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K233825) | Innovative Health | 2024-06-07 |
| Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant (K234099) | Select Labs, LLC | 2024-06-07 |
| Access Thyroglobulin (K241423) | Beckman Coulter, Inc. | 2024-06-07 |
| Corvair (K231010) | AliveCor, Inc. | 2024-06-07 |
| Uro-G HD Flexible Cystoscope (K232837) | Uroviu Corporation | 2024-06-07 |
| Impala (K232035) | AliveCor, Inc. | 2024-06-07 |
| Electrocardiograph, model: ECG301 (K232816) | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| Libre Rio Continuous Glucose Monitoring System (K233861) | Abbott Diabetes Care | 2024-06-07 |
| FibriCheck (K232804) | Qompium NV | 2024-06-07 |
| IPD Dental Implant Abutments (K240570) | Implant Protesis Dental 2004, S.L. | 2024-06-07 |
| Steriking® Pouch for Robotic Instruments (K232625) | Wipak OY | 2024-06-07 |
| Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (K240972) | Surgical Instrument Service and Savings, Inc. | 2024-06-07 |
| HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388) (K232806) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-07 |
| Disposable Hemostatic Clips (K232969) | Ningbo Xinwell Medical Technology Co., Ltd. | 2024-06-07 |
| WaveSense Jazz Blood Glucose Monitoring System (K241304) | Agamatrix | 2024-06-06 |
| Swan-Ganz catheter (K233824) | Edwards Lifesciences, LLC | 2024-06-06 |
| Grande Medical Masks, Model SF-600 (K232968) | Golden Grande Corp. | 2024-06-06 |
| ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01-LH); ArtiSential Laparoscopic Instruments-Electrodes (5AMHD01S-LH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01S-FH); ArtiSential Laparoscopic Instruments-Electrodes (AMHD01L- (K240657) | Livsmed, Inc. | 2024-06-06 |
| Invictus Robotic Navigation Instruments (K240951) | Alphatec Spine | 2024-06-06 |
| CORTRAK* 2 Enteral Access System (20-0950) (K240965) | Avanos Medical, Inc. | 2024-06-06 |
| Wearable Breast Pump,Model S18 (K232774) | Ningbo Dearevery Electronic Technology Co., Ltd. | 2024-06-06 |
| Conical Platform Dental Implants System (K240202) | Noris Medical , Ltd. | 2024-06-06 |
| Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece (K240662) | Stryker Leibinger GmbH & Co KG | 2024-06-06 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K240948) | Imperative Care, Inc. | 2024-06-06 |
| Spinal System (K240963) | Teslake, Inc. | 2024-06-06 |
| Wellead® Latex Foley Catheter (K233094) | Well Lead Medical (Hainan) Co., Ltd. | 2024-06-06 |
| Baby Gorilla/Gorilla Plating System; Monster Screw System (K241262) | Paragon 28, Inc. | 2024-06-05 |
| VELYS Robotic-Assisted Solution (K240211) | Depuy Ireland UC | 2024-06-05 |
| Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) (K240648) | Radiant Innovation, Inc. | 2024-06-05 |
| Tapered Pro Conical Implant System (K240187) | BioHorizons Implant Systems, Inc. | 2024-06-05 |
| ShockPhysio Mobile (model SW3200 Basic) (K240358) | Shenzhen Dongdixin Technology Co., Ltd. | 2024-06-05 |
| Ti-Base & Master Fix (K240603) | Arum Dentistry Co., Ltd. | 2024-06-05 |
| Cannulated Headless Bone Screws (K233008) | Aap Implantate AG | 2024-06-05 |
| Mobility Scooter (W3331) (K240008) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 2024-06-05 |
| Eminent Spine SI Screw System (K240505) | Eminent Spine, LLC | 2024-06-04 |
| HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) (K232820) | Owens & Minor (O&M) Halyard, Inc. | 2024-06-04 |
| da Vinci SP Surgical System (SP1098) (K232773) | Intuitive Surgical, Inc. | 2024-06-04 |
| Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line (K234032) | Medline Industries, LP | 2024-06-04 |
| Monteris Medical NeuroBlate System (K240877) | Monteris Medical, | 2024-06-04 |
| Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024) (K240222) | Aesthetic Technology, Ltd. | 2024-06-04 |
| SAM Model 9-10000 (K240100) | Snap Diagnostics, LLC | 2024-06-04 |
| Arthrex AlloSync PushLock Suture Anchor (K233971) | Arthrex, Inc. | 2024-06-04 |
| Ingenix Spinal System (K241258) | Ingenium Spine | 2024-06-04 |
| Slow Wave DS8 (SWDS802) (K240463) | Slow Wave, Inc. | 2024-06-04 |
| LIAISON PLEX Yeast Blood Culture Assay (K240627) | Luminex Corporation | 2024-06-04 |
| TENSOR® Suture Button System (K240947) | Globus Medical, Inc. | 2024-06-03 |
| LOCATOR Angled Abutment (Various) (K233587) | Zest Anchors, LLC | 2024-06-03 |
| Perforated Baskets (K231291) | Richard Wolf Medical Instruments Corporation | 2024-06-03 |
| ANNE Chest (K240251) | Sibel Health, Inc. | 2024-06-03 |
| EcoFit® short stem cementless cpTi (K240834) | Implantcast GmbH | 2024-06-03 |
| Maestro System (REF100) (K240598) | Moon Surgical | 2024-06-03 |
| Milieve (YPS-301BD) (K233751) | Soterix Medical, Inc. | 2024-06-03 |
| Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS) (K240617) | Olympus Medical Systems Corp. | 2024-06-03 |
| Amplatz Goose Neck Snare Kit (K241259) | Medtronic, Inc. | 2024-06-03 |
| Distinct® Digital Pregnancy Test (K232715) | ACON Laboratories, Inc. | 2024-05-31 |
| Kenota 1 Total IgE; Kenota 1 (instrument) (K231151) | Kenota, Inc. | 2024-05-31 |
| Tyber Medical Anatomical Plating System (K241218) | Tyber Medical, LLC | 2024-05-31 |
| Puracyn® Plus Antimicrobial Irrigation Solution (K232080) | Innovacyn, Inc. | 2024-05-31 |
| Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) (K240912) | Anhui Miisen Intelligence Technology Co., Ltd. | 2024-05-31 |
| Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E) (K240913) | Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd | 2024-05-31 |
| BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) (K232738) | Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla | 2024-05-31 |
| Stylus (K233591) | Degania Silicone , Ltd. | 2024-05-31 |
| Electro Lube NXT (K241055) | Steris | 2024-05-31 |
| IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) (K240969) | Shenzhen Semlamp Intelligent Technology Co., Ltd. | 2024-05-31 |
| Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 (K233729) | Vascular Solutions, LLC | 2024-05-31 |
| Bone Suppression Software (K240281) | Konica Minolta, Inc. | 2024-05-31 |
| CINA-VCF (K240612) | Avicenna.Ai | 2024-05-31 |
| multiFlux 1000 (F00012408) (K240394) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-05-31 |