| Pepper EMS Training System (K233770) | Pepper Interactive, Inc. | 2025-01-16 |
| BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885) | Biofire Diagnostics, LLC | 2025-01-16 |
| TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); (K243569) | TriMed, Inc. | 2025-01-15 |
| GEM ZIPCLIP (K242541) | Synovis Micro Companies Alliance A Subsidiary of Baxter Int | 2025-01-15 |
| Venera 608 Deep Vein Thrombosis (DVT) Prevention System (K241096) | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. | 2025-01-15 |
| Ziehm Vision RFD (K243328) | Ziehm Imaging GmbH | 2025-01-15 |
| AeroChamber2go Anti-Static Valved Holding Chamber (K242667) | Trudell Medical International | 2025-01-15 |
| Respiration Data Management Software (PAP Link PC) (K242935) | BMC Medical Co., Ltd. | 2025-01-15 |
| Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K242936) | Sunray Medical Products, Inc. | 2025-01-15 |
| Ventrax™ Delivery System (K242873) | Merit Medical Systems, Inc. | 2025-01-15 |
| Xpert® Xpress CoV-2 plus (XPRS-COV2-10) (K242109) | Cepheid® | 2025-01-15 |
| Electrode Pad (K241512) | Shenzhen Deliduo Medical Technology Co.,Ltd | 2025-01-15 |
| FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (K243573) | Assure Tech., LLC | 2025-01-15 |
| Cardiac Guidance (K243065) | Caption Health, Inc. | 2025-01-15 |
| Micro Ace Gold Advanced Micro Access System (K242229) | Merit Medical Systems, Inc. | 2025-01-15 |
| PuraStat (K242634) | 3-D Matrix Europe SAS | 2025-01-15 |
| EffortMed Spinal Fixation System (K243946) | Effortmed, LLC | 2025-01-15 |
| AtriClip PRO-Mini LAA Exclusion System (PROM) (K243860) | AtriCure, Inc. | 2025-01-15 |
| RELiZORB (100300/ 100301) (K243284) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge (K243858) | Haemonetics Corporation | 2025-01-15 |
| BB-613-BPM (K241066) | Biobeat Technologies , Ltd. | 2025-01-14 |
| uCT 550 (K241166) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-14 |
| Zoom System (K242672) | Imperative Care, Inc. | 2025-01-14 |
| SpectoMed (v1.0) (K242205) | Specto Medical | 2025-01-14 |
| ABL90 FLEX PLUS System (K241037) | Radiometer Medicals Aps | 2025-01-14 |
| Consensus Knee System with TiNbN (K241180) | Shalby Advanced Technologies | 2025-01-14 |
| Orthoscan VERSA Mini C-Arm (K243452) | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| ASEPT® Glide Peritoneal Drainage System (K241278) | Pfm Medical, Inc. | 2025-01-14 |
| LOCATOR Angled Abutment (K243272) | Zest Anchors, LLC | 2025-01-14 |
| Radical the Dude 8F Guide Catheter (K243577) | Maduro Medical, Inc. | 2025-01-14 |
| APRO 70 Swift Catheter (K243297) | Alembic, LLC | 2025-01-14 |
| Elegance® Anterior Cervical plate (K243904) | Clariance | 2025-01-14 |
| ARVIS® Shoulder (K243950) | Kico Knee Innovation Company Pty, Ltd. | 2025-01-13 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) (K241431) | Joytech Healthcare Co. , Ltd. | 2025-01-13 |
| MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer (K243271) | Mentor Worldwide, LLC | 2025-01-13 |
| AAMI Level 4 Protective; Gown (K242689) | Azac Group | 2025-01-13 |
| MegaGen Dental Implant Abutment (K242030) | Megagen Implant Co., Ltd. | 2025-01-13 |
| SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200) | Arineta , Ltd. | 2025-01-13 |
| Air Pressure Therapy System (K243791) | Xiamen Weiyou Intelligent Technology Co., Ltd. | 2025-01-13 |
| High Flow Insufflation Unit (UHI-4) (K243527) | Olympus Medical Systems Corporation | 2025-01-13 |
| Pantheon Proximal Femur Reconstruction (PFR) System (K241059) | Adler Ortho S.P.A | 2025-01-13 |
| LetsGetChecked Impress (K242680) | Privapath Diagnostics Ltd (Dba Letsgetchecked) | 2025-01-13 |
| QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (K243262) | Osang, LLC | 2025-01-13 |
| Vivo 45 LS (K233452) | Breas Medical AB | 2025-01-13 |
| Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (K243533) | Hlb Co., Ltd. Healthcare | 2025-01-13 |
| Initia Knee System (K243295) | Kyocera Medical Technologies, Inc. | 2025-01-13 |
| Arthrex Intramedullary Nails (K243890) | Arthrex, Inc. | 2025-01-13 |
| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
| Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836) | Mentor Worldwide, LLC | 2025-01-12 |
| Electric Wheelchair (YE200) (K241641) | Shenzhen Yattll Industry Co., Ltd. | 2025-01-11 |
| PeriCALM Patterns 3.0 (K241009) | Perigen, Inc. | 2025-01-10 |
| Safecare Urinary Tract Infection Test (K242767) | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 |
| Solo Pace Control (K241781) | Solo Pace, Inc. | 2025-01-10 |
| ScreenDx (K241891) | Imvaria, Inc. | 2025-01-10 |
| ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40) (K242901) | Tools For Surgery, LLC | 2025-01-10 |
| Bowhead ERA Wheelchairs (K243111) | Bowhead Design Corp. | 2025-01-10 |
| BioCode Gastrointestinal Pathogen Panel (GPP) (K242877) | Applied BioCode, Inc. | 2025-01-10 |
| Universal Tendon Spacer (K243477) | Askorn Medical | 2025-01-10 |
| Mould Probe MR Safe (K241764) | Varian Medical Systems, Inc. | 2025-01-10 |
| Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) (K242528) | Shenzhen Ruiankang Technology Co., Ltd. | 2025-01-10 |
| INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator) (K241174) | Carl Zeiss Meditec, AG | 2025-01-10 |
| OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (K242366) | Overfibers S.R.L. | 2025-01-10 |
| NuVasive Pulse System (K243814) | Globus Medical, Inc. | 2025-01-10 |
| Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01) (K242228) | Triopsy Medical, Inc. | 2025-01-10 |
| Unscented Tampon (K241064) | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 |
| Klaxon (Twist); Klaxon (Twist R) (K240267) | Klaxon Mobility GmbH | 2025-01-10 |
| Xpert Xpress CoV-2/Flu/RSV plus (K242071) | Cepheid | 2025-01-10 |
| Arthrex SS VAL and VAL KreuLock™ Compression Screw System (K243195) | Arthrex, Inc. | 2025-01-10 |
| Ulike Reglow Light Therapy Device (UM10) (K243492) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2025-01-10 |
| TriVerity (K241676) | Inflammatix, Inc. | 2025-01-10 |
| Safety Winged Blood Collection Sets (K243806) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 |
| Erchonia Zerona® VZ8 (K243811) | Erchonia Corporation | 2025-01-10 |
| Dental Cone-beam Computed Tomography (FinScan F350) (K242805) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 |
| FullFocus (K241273) | Paige.Ai, Inc. | 2025-01-09 |
| Sperm Freezing Medium (K242043) | Gimbo Medical Technology Shenzhen Co., Ltd. | 2025-01-08 |
| DormoTech NLab (K242290) | Dormotech Medical, Ltd. | 2025-01-08 |
| TRI-matrix® X-Force Implants (K242661) | Tri Dental Implants Int. AG | 2025-01-08 |
| Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel (K241806) | Life Technologies Corporation | 2025-01-08 |
| ACE Cannula (K242741) | Ace Medical Industry Co., Ltd. | 2025-01-08 |
| QIAstat-Dx GI Panel 2 Mini B&V (K243813) | QIAGEN GmbH | 2025-01-08 |
| Electrical Scooter, WT-T4SU (K240590) | W'U'S Tech Co., Ltd. | 2025-01-08 |
| HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) (K241003) | Hiossen, Inc. | 2025-01-08 |
| ReminGel (K241489) | Inter-Med, Inc. | 2025-01-08 |
| Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) (K243818) | Hartalega NGC Sdn. Bhd. | 2025-01-08 |
| Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) (K243644) | Ceragem Co., Ltd. | 2025-01-08 |
| ANNE View, Central Hub (K242842) | Sibel Health, Inc. | 2025-01-08 |
| GlutenID Celiac Genetic Health Risk Test (K241456) | Targeted Genomics, LLC | 2025-01-07 |
| uCT 780 (K241079) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-01-07 |
| COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) (K242588) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 |
| Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR (K243335) | Canon Medical Systems Corporation | 2025-01-07 |
| ApolloHipX (THR.SS.0001) (K241808) | Corin U.S.A. Limited | 2025-01-07 |
| GXR-Series Diagnostic X-Ray System (K242019) | DRGEM Corporation | 2025-01-07 |
| MASADA Modular Spinal Fixation System (K243259) | Astura Medical | 2025-01-07 |
| Soteria E-View (K242488) | Omega Medical Imaging, LLC | 2025-01-06 |
| Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (K242499) | Shenzhen Sontu Medical Imaging Equipment Co., Ltd. | 2025-01-06 |
| Conformity Stem Extension Line, #0 (K243466) | United Orthopedic Corporation | 2025-01-06 |
| Mobility Scooter (YL-09B, YL-07) (K242139) | Yongkang Yile Vehicle Co., Ltd. | 2025-01-06 |
| SD TL Implant System (K242753) | Arum Dentistry Co., Ltd. | 2025-01-06 |
| Brainomix 360 e-CTA (K242123) | Brainomix Limited | 2025-01-06 |
| TMINI Miniature Robotic System (K243481) | THINK Surgical, Inc. | 2025-01-06 |