| HemoSphere Nano Monitor (HSNANO1) (K253186) | Edwards Lifesciences, LLC | 2026-02-24 |
| Universal Seal (5-12 mm) (K253978) | Intuitive Surgical, Inc. | 2026-02-24 |
| Electric wheelchair (W1,W3) (K253707) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-24 |
| Diode Laser Therapy Systems (WLA-02) (K252599) | Wingderm Electro-Optics , Ltd. | 2026-02-24 |
| NanoPress 760A-BT (760A-BT) (K254267) | Mego Afek , Ltd. | 2026-02-24 |
| SP Electrocautery Device (SP20) (K260287) | Single Pass, Inc. | 2026-02-24 |
| OSTEOMNI SPINAL FIXATION SYSTEM (K254247) | Osteomni, Inc. | 2026-02-24 |
| XSense Cryoablation System with CryoProbes (K260377) | IceCure Medical , Ltd. | 2026-02-24 |
| Duet™ Spinal Fixation System (K253169) | Box Spine, LLC | 2026-02-23 |
| Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) (K260043) | Smart Reactors | 2026-02-23 |
| MAGNETOM Flow.Ace; MAGNETOM Flow.Plus (K260265) | Siemens Shenzhen Magnetic Resonance , Ltd. | 2026-02-23 |
| IPL Hair Removal Device (Models: T31A, T32A) (K253666) | Shenzhen Mlay Intelligent Technology Co., Ltd. | 2026-02-23 |
| VITA VMLC Primer (K251587) | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 2026-02-23 |
| Rubber Utility Catheter (K251864) | C.R. Bard, Inc. | 2026-02-23 |
| Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades (K253648) | Philips Medical Systems Nederland B.V. | 2026-02-23 |
| SKIA-Head (Model: SKIA-ST00) (K253486) | Skia, Inc. | 2026-02-23 |
| ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial (K252795) | Argon Medical Devices, Inc. | 2026-02-23 |
| Mariana Minerva; Mariana Nimbus (K251661) | Resmed Pty , Ltd. | 2026-02-23 |
| AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (K253244) | Poskom Co., Ltd. | 2026-02-23 |
| Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (K253068) | CMT Health PTE., Ltd. | 2026-02-23 |
| Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) (K253531) | Applied Medical Resources Corporation | 2026-02-23 |
| YUWELL® Electronic Blood Pressure Monitor (YE650AR) (K253228) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
| LUX Expandable Lumbar Interbody System (K253583) | Xenix Medical | 2026-02-23 |
| Mobility Scooter (CL-Q3, CL-Q4) (K253631) | Zhejiang Wei Ling New Energy Technology Co., Ltd. | 2026-02-23 |
| Single Use Distal Cover MAJ-2315 (MAJ-2315) (K253646) | Olympus Medical Systems Corp. | 2026-02-22 |
| Advanced Tissue Resection Device (K251692) | Micro-Tech (Nanjing) Co., Ltd. | 2026-02-21 |
| QSCHECK UISACR (K252619) | Qstag, Inc. | 2026-02-20 |
| CARA System (K252500) | Cara Medical, Ltd. | 2026-02-20 |
| BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (K253445) | Bd | 2026-02-20 |
| Safety Heel Lancet (K253605) | Ningbo Medsun Medical Co., Ltd. | 2026-02-20 |
| “POINT” Kinguide Agile Hybrid Navigation System; DRF Accessories Set (K252989) | Point Robotics MedTech, Inc. | 2026-02-20 |
| CARTO™ 3 EP Navigation System V8.4 (K252972) | Biosense Webster, Inc. | 2026-02-20 |
| LF Process Indicator Tape for Steam Sterilization (K260181) | Intertape Polymer Group | 2026-02-20 |
| Xpert Hemorrhagic Fever (K253653) | Cepheid | 2026-02-20 |
| SPRY TMS Therapy System (0550) (K251653) | Soterix Medical, Inc. | 2026-02-20 |
| KLS Martin Pure Pectus System (K253660) | KLS-Martin L.P. | 2026-02-20 |
| Disposable Ureteral Stents (K251890) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 |
| CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5) (K252672) | Casebioscience, Inc. | 2026-02-20 |
| FAQ™ (LED Panel); FAQ™ (Dual LED Panel) (K253683) | Foreo, Inc. | 2026-02-20 |
| KLS Martin Ixos System (K254162) | KLS Martin L.P. | 2026-02-20 |
| AS Software Version Asera (K260205) | AS Software, LLC | 2026-02-19 |
| Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (K252597) | Alphatec Spine, Inc. | 2026-02-19 |
| Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle; Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (K252814) | CMT Health PTE., Ltd. | 2026-02-19 |
| Meniscus Versaflex (K254188) | GM Dos Reis Industria e Comercio Ltda. | 2026-02-19 |
| SkinStylus SteriLock MicroSystem (MP1209SL) (K253002) | Esthetic Medical, Inc. | 2026-02-19 |
| TrueFit Bolus (K260308) | Adaptiiv Medical Technologies, Inc. | 2026-02-19 |
| Erchonia DPN Laser (Model# EVRL) (K251903) | Erchonia Corporation | 2026-02-19 |
| Acclarent AERA Eustachian Tube Balloon Dilation System (K253612) | Acclarent, Inc. | 2026-02-19 |
| Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor (K253623) | Stryker Leibinger GmbH & Co KG | 2026-02-19 |
| LacertaMatrix (K260218) | Lacerta Life Sciences | 2026-02-19 |
| ATLAS™ Expandable Osteotomy Wedge System (K252733) | MiRus, LLC | 2026-02-19 |
| VERTICALE GPS Instruments (K254148) | Silony Medical GmbH | 2026-02-19 |
| Access anti-HBc Total (K253687) | Beckman Coulter, Inc. | 2026-02-19 |
| Retrograde Coronary Sinus Perfusion Cannulae (K253203) | Medtronic, Inc. | 2026-02-19 |
| Portable Dental X-ray Device (GT-1) (K254018) | Guilin Refine Medical Instrument Co., Ltd. | 2026-02-19 |
| AuST CSP Introducer (K260163) | CenterPoint Systems, LLC | 2026-02-19 |
| Monaco RTP System (6.3) (K252002) | Elekta Solutions AB | 2026-02-19 |
| Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) (K253398) | Efofex, Inc. | 2026-02-19 |
| Nobel Biocare S Series Implants (K252197) | Nobel Biocare AB | 2026-02-18 |
| Mobility Scooter (S3) (K253643) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | 2026-02-18 |
| 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality (K260185) | Stryker Endoscopy | 2026-02-18 |
| Alere NT-proBNP for Alinity i (K253539) | Axis-Shield Diagnostics, Ltd. | 2026-02-18 |
| PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) (K252098) | Methyl Co., Ltd. | 2026-02-18 |
| BTL-754FF (K252561) | BTL Industries, Inc. | 2026-02-18 |
| Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert (K253637) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) (K254089) | Centerline Biomedical, Inc. | 2026-02-17 |
| Biosteon® Screw (K251680) | Biocomposites, Ltd. | 2026-02-17 |
| YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (K252805) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-17 |
| Electric Wheelchair (W-A807, W-A807L) (K253599) | Ningbo Shenyu Medical Equipment Co.,Ltd | 2026-02-17 |
| FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit (K250550) | Fujifilm Corporation | 2026-02-17 |
| Adaptos®Fuse Bone Graft (K253524) | Biomendex OY | 2026-02-17 |
| Versus™ Catheter (VS110-9NB) (K260149) | Liquet Medical, Inc. | 2026-02-17 |
| cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) (K251852) | VPIX Medical, Inc. | 2026-02-13 |
| CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21) (K251928) | Medinice S.A. | 2026-02-13 |
| Babyleo TN500 (K251619) | Drägerwerk AG & Co. KGaA | 2026-02-13 |
| MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) (K252891) | Bayer Medical Care, Inc. | 2026-02-13 |
| Contour Light (CL-100) (K243854) | Contour Research, LLC | 2026-02-13 |
| Hive™ Standalone Cervical System and Hive™ C Interbody System (K254105) | NanoHive Medical, LLC | 2026-02-13 |
| Wrist Blood Pressure Monitor (BPM-W1VL) (K253133) | Shenzhen Imdk Medical Technology Co., Ltd. | 2026-02-13 |
| Armada™ 14 NC PTA Catheter (K252512) | ABBOTT MEDICAL | 2026-02-13 |
| NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) (K253089) | Shenzhen Best Electronics Co., Ltd. | 2026-02-13 |
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| Willow 18 Guidewire (K260130) | Arbor Endovascular, LLC | 2026-02-13 |
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (K251581) | Shenzhen Hingmed Medical Instrument Co., Ltd. | 2026-02-13 |
| PreOp v3 (K252565) | Clouds of Care | 2026-02-13 |
| Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) (K252685) | Joytech Healthcare Co. , Ltd. | 2026-02-13 |
| Endomina EZFuse system (K252400) | Endo Tools Therapeutics S.A. | 2026-02-13 |
| VELO Respiratory Test (K251742) | Lex Diagnostics Limited | 2026-02-13 |
| Motion InBra (YM-8801) wearable breast pump (K253149) | Medela, LLC | 2026-02-13 |
| uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) (K253564) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 |
| Wearable Breast Pump (Model W2) (K252422) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 |
| Wearable Breast Pump (Model W12) (K252420) | Shenzhen TPH Technology Co., Ltd. | 2026-02-13 |
| STAR RF Ablation System (K251802) | Merit Medical Systems, Inc. | 2026-02-13 |
| PreemptiveAI Clinical SDK (K250233) | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026-02-13 |
| Argos Infinity (Rev. 1.0) (K253092) | Retia Medical Systems, Inc. | 2026-02-13 |
| Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) (K253354) | Guangzhou Hehong Biotech Co., Ltd. | 2026-02-12 |
| Well-Life Incontinence Stimulation System (WL-2405i(P)) (K251760) | Well-Life Healthcare , Ltd. | 2026-02-12 |
| Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490) | Roche Diagnostics | 2026-02-12 |
| Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1) (K260177) | Xenocor, Inc. | 2026-02-12 |