| CeraRoot TL Implant System (TL) (K242072) | Ceraroot SL | 2025-05-14 |
| Promisemed Safety Huber Needles (K251138) | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 |
| Aesculap Aicon® Series Container System (K242762) | Aesculap, Inc. | 2025-05-13 |
| Ulthera System (UC-1 Control Unit PRIME Model 2.1) (K250418) | Ulthera, Inc. | 2025-05-13 |
| Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 (K242808) | Canon Medical Systems Corporation | 2025-05-13 |
| Freedom Posterior Cervical Screws (K242674) | Signature Orthopaedics Pty, Ltd. | 2025-05-13 |
| SP Endoscope, 0° (430600) (K250786) | Intuitive Surgical, Inc. | 2025-05-13 |
| ZircaGlow & ZircaGlow HT Zirconia (K250393) | United Zirconia | 2025-05-12 |
| AYON Body Contouring System (AYON SYSTEM) (K244050) | Apyx Medical Corporation | 2025-05-12 |
| uWS-Angio Basic (K243632) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-05-12 |
| Reon (K250763) | C.E.I.B.Med | 2025-05-12 |
| Medical Diode Laser Hair Removal System (MNLT-D1) (K250431) | Shandong Moonlight Electronics Tech Co., Ltd. | 2025-05-12 |
| Shoulder Soft Tissue Anchors (K242477) | Signature Orthopaedics Pty, Ltd. | 2025-05-12 |
| NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) (K250592) | Northeast Scientific, Inc. | 2025-05-12 |
| Archer PSI System (K243509) | 3D-Side | 2025-05-12 |
| P-Cure Proton Therapy System (PPTS) (K242418) | P-Cure, Ltd. | 2025-05-12 |
| InThrill™ Thrombectomy System (K250421) | Inari Medical, Inc. | 2025-05-12 |
| SPECTRALIS HRA+OCT and variants (K250868) | Heidelberg Engineering GmbH | 2025-05-12 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) (K250360) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-11 |
| Flowflex Plus COVID-19 + Flu A/B Home Test (K250377) | ACON Laboratories, Inc. | 2025-05-10 |
| SKOUT system (K251126) | Iterative Health | 2025-05-09 |
| Water Solubility Human Body Lubricant (K243107) | Dongguan Yanxuan Biotechnology Co., Ltd. | 2025-05-09 |
| DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls (K242294) | Diasys Diagnostic Systems GmbH | 2025-05-09 |
| TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) (K250053) | Shenzhen Jiantuo Electronics Co., Ltd. | 2025-05-09 |
| Avidhrt Sense SpO2 (K241086) | Avidhrt, Inc. | 2025-05-09 |
| Second Opinion® BLE (K243230) | Pearl, Inc. | 2025-05-09 |
| BTL-785MJ (K243290) | BTL Industries, Inc. | 2025-05-09 |
| Electric Wheelchair (F309) (K250758) | Changshu Pingfang Wheelchair Co., Ltd. | 2025-05-09 |
| VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D) (K251103) | Philips Image Guided Therapy Corporation | 2025-05-09 |
| PATH BGC (K242392) | Crossroads Neurovascular, Inc. | 2025-05-09 |
| Tristel OPH (K242732) | Tristel Solutions , Ltd. | 2025-05-09 |
| LensHooke X12 PRO Semen Analysis System (K242388) | Bonraybio Co., Ltd. | 2025-05-09 |
| Teal Wand (DEN240045) | Teal Health, Inc. | 2025-05-09 |
| turbodent touch (K251425) | Mectron S.P.A. | 2025-05-09 |
| Volta AF-Xplorer (K243812) | Volta Medical | 2025-05-09 |
| EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems (K251110) | Philips Ultrasound, LLC | 2025-05-09 |
| Vigeon Laparoscopic Universal Smoke Evacuator (VG003) (K250400) | Vigeon Technology Co., Ltd. | 2025-05-09 |
| SteadiSet Infusion Set (K242692) | Capillary Biomedical, LLC | 2025-05-09 |
| Altaviz Intravitreal Syringe (K243322) | Altaviz, LLC | 2025-05-09 |
| CT/ MR Tandem and Ovoid Set (K250299) | Varian Medical Systems, Inc. | 2025-05-09 |
| COLONNADE Posterior Screw Fixation System (K250582) | CG Bio Co., Ltd. | 2025-05-08 |
| eFOLDi Navigator Powerchair (STPC-A) (K243110) | Suntech UK , Ltd. | 2025-05-08 |
| Ultrasound Imaging System (LU700 Series); Ultrasound Imaging System (128 Series); Ultrasound Imaging System (LX Series) (K243226) | Leltek, Inc. | 2025-05-08 |
| AVEA disposable expiratory filter/water trap (11790) (K251133) | Telesair, Inc. | 2025-05-08 |
| Lumify Diagnostic Ultrasound System (K242670) | Philips Ultrasound | 2025-05-08 |
| Preat Abutments (K243824) | Preat Corporation | 2025-05-08 |
| Clarius Median Nerve AI (K250226) | Clarius Mobile Health Corp. | 2025-05-08 |
| Altus Spine Navigation System (K243419) | Altus Partners, LLC | 2025-05-08 |
| Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) (K243764) | Wuhan Pioon Technology Co., Ltd. | 2025-05-08 |
| OsseOne Dental Implant System (K233271) | Synoross Dba Osseone | 2025-05-08 |
| Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue (K250482) | Fissiontech, LLC | 2025-05-08 |
| NextStep Arthropedix Total Knee System (K242410) | Nextstep Arthropedix | 2025-05-08 |
| Mobility Scooter (Model X-01, X-02) (K242975) | Wuyi Aichi Industry & Trade Co., Ltd. | 2025-05-07 |
| Cary (K251111) | Excitus AS | 2025-05-07 |
| SDF Pro (K250222) | Belport Company, Inc., Gingi-Pak | 2025-05-07 |
| BrightHeart View Classifier (K243684) | Brightheart | 2025-05-07 |
| Extremity Medical External Fixation System (K251128) | Extremity Medical, LLC | 2025-05-07 |
| Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) (K243776) | Zeus Scientific | 2025-05-07 |
| IPL Hair Removal Device (KCA511/KCA516/KCA522) (K250253) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2025-05-06 |
| Alma Veil (K251094) | Wontech Co., Ltd. | 2025-05-06 |
| !M1 (K241980) | Solutions For Tomorrow AB | 2025-05-06 |
| Single-use Flexible Ureteroscope (K250785) | Hunan Vathin Medical Instrument Co., Ltd. | 2025-05-06 |
| IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) (K243017) | Foshan Newface Electronic Technology Co., Ltd. | 2025-05-06 |
| ANKYRAS (K250160) | Mentice Spain S.L. | 2025-05-06 |
| Telemetry Monitor 5500 Release 4.0 (867232) (K242962) | Philips Medizin Systeme Böblingen GmbH | 2025-05-05 |
| ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) (K240447) | Thermasolutions, LLC | 2025-05-05 |
| Second Opinion® Pediatric (K243893) | Pearl, Inc. | 2025-05-05 |
| DentaTOOTH (K243370) | Asiga Pty, Ltd. | 2025-05-05 |
| ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) (K242754) | Zamar Medical D.O.O. | 2025-05-05 |
| AeviceMD (K243603) | Aevice Health Pte. , Ltd. | 2025-05-05 |
| Dream Medi Sterile Surgical Gown (SurgicalGownUL) (K242937) | Dae Myung Chemical Co., Ltd. (Vietnam) | 2025-05-05 |
| Arthrex Synergy Vision Endoscopic Imaging System (K250728) | Arthrex, Inc. | 2025-05-05 |
| Bluemoon (K242386) | Genoss Co., Ltd. | 2025-05-05 |
| SpO2 Extension Cable (K242986) | Beijing Rongrui-Century Science & Technology Co., Ltd. | 2025-05-02 |
| Fetal EchoScan (v1.1) (K251071) | Brightheart | 2025-05-02 |
| i-STAT CG4+ cartridge with the i-STAT 1 System (K244014) | Abbott Point of Care, Inc. | 2025-05-02 |
| LUMYS (V1) (K243069) | Intradys | 2025-05-02 |
| F88 URE-SD/RD Flexible Ureteroscope (K243894) | Sg Endoscopy Pte, Ltd. | 2025-05-02 |
| Sutil Rich Personal Lubricant (K250629) | Hathor Professional Skincare , Ltd. | 2025-05-02 |
| AT-Patch (ATP-C130/ATP-C70) (K242583) | Atsens Co., Ltd. | 2025-05-02 |
| SQA-iOw Sperm Quality Analyzer (K243114) | Medical Electronic Systems , Ltd. | 2025-05-02 |
| CIONIC NEURAL SLEEVE (NS-200) (K243828) | Cionic, Inc. | 2025-05-02 |
| Origin™ Cemented Hip Stem (K243043) | Signature Orthopaedics Pty, Ltd. | 2025-05-02 |
| Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048) | STERIS Corporation | 2025-05-02 |
| Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel (K243457) | Seriously Clean, Ltd. | 2025-05-02 |
| Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo (K250161) | Shenzhen AOJ Medical Technology Co., Ltd. | 2025-05-02 |
| JetCan® Pro Safety Huber Needle (K242763) | Pfm Medical, Inc. | 2025-05-02 |
| Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode (K251056) | Momentis Surgical , Ltd. | 2025-05-02 |
| Shockwave CS Guide Catheter (K243757) | Shockwave Medical, Inc. | 2025-05-02 |
| OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) (K250292) | Skydance Vascular, Inc. | 2025-05-02 |
| KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2) (K244001) | Karl Storz SE & CO. KG | 2025-05-02 |
| APEX 3D Total Ankle Replacement System (K250641) | Paragon 28, Inc. | 2025-05-01 |
| Xpert Xpress CoV-2/Flu/RSV plus (K250996) | Cepheid® | 2025-05-01 |
| Resolve Modular Revision Hip Stem (K242315) | United Orthopedic Corporation | 2025-05-01 |
| Conical Ti Base abutments (K243521) | BioHorizons Implant Systems, Inc. | 2025-05-01 |
| Disposable Distal Attachment D-201 Series (K250296) | Olympus Medical Systems Corp. | 2025-05-01 |
| Vscan Air (K250087) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025-05-01 |
| APRO 45 Catheter (K251014) | Alembic, LLC | 2025-05-01 |
| CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) (K251007) | Circa Scientific, Inc. | 2025-05-01 |
| X°Port Lung Preservation System; X°Port Lung Preservation Solution (K243870) | Traferox Technologies, Inc. | 2025-05-01 |