| LYNX Photocoagulator (K242397) | Norlase Aps | 2024-10-25 |
| Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) (K243030) | Ulike Co., Ltd. | 2024-10-25 |
| CORGRIP* SR NG/NI Tube Retention System (K241185) | Avanos Medical, Inc. | 2024-10-25 |
| Pantera Pro; Pantera LEO (K242969) | Biotronik, Inc. | 2024-10-25 |
| Salto Talaris Ankle PSI System (K243173) | 3D Systems, Inc. | 2024-10-25 |
| LCD Monitors C310S, G310S, C316S, G316S, C616W (K243031) | Shenzhen Beacon Display Technology Co., Ltd. | 2024-10-25 |
| Neurophet AQUA (V3.1) (K242215) | Neurophet., Inc. | 2024-10-25 |
| BKS Revision System (K242984) | Ortho Development Corp. | 2024-10-25 |
| Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (K240092) | Shenzhen Yimi Life Technology Co., Ltd. | 2024-10-25 |
| QIAstat-Dx Respiratory Panel Mini (K242353) | QIAGEN GmbH | 2024-10-25 |
| FMT Disposable and Autoclavable Temperature Probes (K240223) | Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi | 2024-10-25 |
| Xpert® SA Nasal Complete (K243070) | Cepheid® | 2024-10-25 |
| Dexter L6 System (DEN230084) | Distalmotion SA | 2024-10-25 |
| Nitrile Powder Free Examination Gloves Biodegradable (Green) (K240269) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2024-10-25 |
| Cadence Ankle PSI System (K243174) | 3D Systems, Inc. | 2024-10-25 |
| VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040) | VATECH Co., Ltd. | 2024-10-25 |
| Freeze Point & Private Label Versions (K242625) | Cryoconcepts LP | 2024-10-25 |
| LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle (K242956) | Ocuject, LLC | 2024-10-25 |
| Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia; Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Astigmatism (K240918) | Bruno Vision Care, LLC | 2024-10-25 |
| TumorSight Viz (K243189) | SimBioSys, Inc. | 2024-10-25 |
| ROCC Console (K242512) | Philips Medical Systems Nederland B.V. | 2024-10-24 |
| Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) (K241554) | Telefield Medical Imaging (Shenzhen) Limited | 2024-10-24 |
| Manual Wheelchair (SYIV100-CA9221) (K242560) | Foshan Shunkangda Medical Tech Co., Ltd. | 2024-10-24 |
| ArgenZ MTZ (K242458) | Argen Corporation | 2024-10-24 |
| Duet External Drainage and Monitoring System (EDMS) (K242034) | Medtronic Neurosurgery | 2024-10-24 |
| MagDI System (MAG-01, DS-01) (K242086) | Gt Metabolic Solutions, Inc. | 2024-10-24 |
| Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (K241007) | Shenzhen Urion Technology Co., Ltd. | 2024-10-24 |
| KeyPrint KeyDenture Base (K241089) | Keystone Industries | 2024-10-24 |
| Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) (K240543) | Medency S.R.L. | 2024-10-24 |
| MUTARS® femoral stem cemented 160 mm and 200 mm (K240391) | Implantcast GmbH | 2024-10-24 |
| CEREC Cercon 4D CAD/CAM Blocks (K242462) | Dentsply Sirona | 2024-10-24 |
| LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system (K241324) | Affinity Biosensors, LLC | 2024-10-23 |
| Fractional CO2 Laser Therapy System (EXFU CO2) (K242183) | Weifang Mingliang Electronics Co., Ltd. | 2024-10-23 |
| BluEX Lumbar Expandable Cage System (K242829) | L&K BIOMED Co., Ltd. | 2024-10-23 |
| STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS) (K242073) | Tsk Laboratory International Japan KK | 2024-10-23 |
| EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA); (K242847) | DRTECH Corporation | 2024-10-23 |
| FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) (K242513) | Guangdong Optomedic Technologies, Inc. | 2024-10-23 |
| CD Horizon™ Spinal System (K243007) | Medtronic Sofamor Danek USA, Inc. | 2024-10-23 |
| KIDNEYvault Portable Renal Perfusion System (K234060) | Paragonix Technologies | 2024-10-23 |
| ProSeal™ Closed System Bag Access (K241988) | Epic Medical Pte. , Ltd. | 2024-10-23 |
| Scarlet® AL-T (K242589) | Spineart SA | 2024-10-23 |
| MIM – Symphony HDR Fusion (K243012) | Mim Software, Inc. | 2024-10-23 |
| Vitesse (5.0) (K241876) | Varian Medical Systems | 2024-10-23 |
| Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) (K240289) | Scivita Medical Technology Co., Ltd. | 2024-10-23 |
| TrueFit Bolus; TrueFlex Bolus (K243057) | Adaptiiv Medical Technologies, Inc. | 2024-10-23 |
| IDS-iSYS Free Testosterone (K240865) | Immunodiagnostic Systems Limited | 2024-10-23 |
| OIC Small / Mini Fragment Plate System (K242995) | The Orthopaedic Implant Company | 2024-10-23 |
| Immediate Molar Implants (K241753) | Biomet 3i, LLC | 2024-10-23 |
| Arm Type Blood Pressure Monitor (BPM82) (K242193) | Avita Corporation | 2024-10-22 |
| ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A) (K241572) | Siemens Medical Solutions USA, Inc. | 2024-10-22 |
| PuraStat (K242250) | 3-D Matrix Europe SAS | 2024-10-22 |
| SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses (K241398) | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) (K241532) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024-10-22 |
| Tri-Wedge PTA Scoring Balloon Dilatation Catheter (K241478) | Brosmed Medical Co., Ltd. | 2024-10-22 |
| KARL STORZ Holders (K240506) | Karl Storz Endoscopy America, Inc. | 2024-10-22 |
| nordicMEDiVA (K243209) | Nordicneurolab AS | 2024-10-22 |
| Reprocessed RD SET Adt Pulse Oximeter Sensor (4000); Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001); Reprocessed RD SET Inf Pulse Oximeter Sensor (4002); Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) (K241758) | Stryker Sustainability Solutions | 2024-10-22 |
| Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle (K242099) | Sol-Millennium Medical, Inc. | 2024-10-22 |
| Digital Prism Correction Feature (DPCF) (K242058) | Apple, Inc. | 2024-10-21 |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation (K242266) | Stryker Instruments | 2024-10-21 |
| Dynamic TiBase; TRI Screws (K241170) | Talladium España, SL | 2024-10-21 |
| Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems (K240783) | Smith & Nephew, Inc. | 2024-10-21 |
| Arthrex VAL and VAL KreuLock™ Compression Screw System (K242554) | Arthrex, Inc. | 2024-10-21 |
| Anovo Surgical System (Model 6Ne) (K242157) | Momentis Surgical , Ltd. | 2024-10-21 |
| Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch (K222740) | Speciality Fibres and Materials, Ltd. | 2024-10-21 |
| Zio AT® device (A100A1001) (K240029) | iRhythm Technologies, Inc. | 2024-10-21 |
| Corplex P/ Theracor P/ Allacor P (K242828) | Stimlabs, LLC | 2024-10-18 |
| Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (K241830) | Sleepnet Corporation | 2024-10-18 |
| Pixie Skin Tag (K240226) | Oystershell NV | 2024-10-18 |
| Surgical Face Mask (Tie on/ Ear loops) (K240916) | Xiantao Daoqi Plastic Co., Ltd. | 2024-10-18 |
| Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic Sling System (519562) (K242473) | Coloplast Corp. | 2024-10-18 |
| PreXolid CAD/CAM abutments (K240725) | Eclectic Co., Ltd. | 2024-10-18 |
| Spectral CT 7500 RT (K240844) | Philips Medical Systems Technologies , Ltd. | 2024-10-18 |
| dS Wrist coil 8ch 1.5T (K243033) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner (K242813) | Materialise NV | 2024-10-18 |
| Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator (K233054) | Well-Life Healthcare Limited | 2024-10-18 |
| FREDDO (K242132) | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | 2024-10-18 |
| SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture (K222944) | Safepath Medical, Inc. | 2024-10-18 |
| edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK (K241131) | Edelweiss Dentistry Products GmbH | 2024-10-18 |
| Dental Barrier and Sleeves (K242435) | Wellmed Dental Medical Supply Co., Ltd. | 2024-10-18 |
| BriefCase-Triage (K242837) | Aidoc Medical , Ltd. | 2024-10-18 |
| ROSA® Knee System (K242864) | Orthosoft Inc. (d/b/a) Zimmer CAS | 2024-10-18 |
| Vittra APS Unique Flow (K232994) | Dentscare Ltda | 2024-10-18 |
| Mg OSTEOREVIVE™, Mg OSTEOCRETE™ (K242372) | Bone Solutions, Inc. | 2024-10-18 |
| IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) (K243245) | Boston Scientific Corp | 2024-10-18 |
| Kinos Total Ankle System (K242868) | Restor3D | 2024-10-18 |
| 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M) (K241959) | 3M Company | 2024-10-18 |
| ABCcolla® Collagen ADM Scaffold (K233378) | Acro Biomedical Co., Ltd. | 2024-10-18 |
| Contour+ (MVision AI Segmentation) (K241490) | Mvision AI OY | 2024-10-18 |
| dS Knee Coil 8ch 1.5T (K242879) | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| Electrically powered wheelchair (HP202) (K241337) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2024-10-17 |
| Hidroxa SE30 (K241267) | Hidroxa Medical AB | 2024-10-17 |
| REMI-AI Rapid Detection Module (REMI-AI RDM) (K240408) | Epitel, Inc. | 2024-10-17 |
| Zipline Access Catheter (K240711) | Perfuze, Ltd. | 2024-10-17 |
| Microlyte Ag/Lidocaine (K211943) | Imbed Biosciences | 2024-10-17 |
| Ascent Cardiorespiratory Diagnostic Software (K242809) | Medical Graphics Corporation | 2024-10-17 |
| IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (K242197) | Shenzhen Huaruibo Electric Appliances Co., Ltd. | 2024-10-17 |
| MP Pin flat without thread (36BMP000020/MP20) (K240321) | Hager& Meisinger GmbH | 2024-10-17 |
| NOVA Minimally Invasive System (K242899) | Baui Biotech Co., Ltd. | 2024-10-17 |
| Electric Breast Pump (F5055) (K240218) | Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd. | 2024-10-17 |