| DELTAWAVE Nasal Pillows System (K233415) | Remsleep Holdings | 2024-07-02 |
| Tyto Insights for Crackles Detection (K240555) | Tyto Care , Ltd. | 2024-07-02 |
| Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) (K233440) | Philips Medizin Systeme Boeblingen GmbH | 2024-07-02 |
| Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) (K240707) | Shenzhen Micro Electric Intelligence Co., Ltd. | 2024-07-02 |
| ZIEN IO Intraosseous Access System (K240915) | Zien Medical Technologies, Inc. | 2024-07-02 |
| iFuse TORQ® Implant System (K241574) | SI-BONE, Inc. | 2024-07-02 |
| Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 15’ (4.6m) (VSMP15); Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m), Non-Sterile Bulk (VSMP10NSB); Valleylab™ SM Smoke Management Extended Nozzle (for use with 4” (100mm) electrode) (VSMEN4); Valleylab™ SM Smoke Management Extended Nozzle (for use with 6.5” (165mm) electrode) (VSMEN6) (K240572) | Covidien, LLC | 2024-07-01 |
| LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -– Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope – Reverse (without pressure monitoring) (M0067941500) (K241598) | Boston Scientific Corporation | 2024-07-01 |
| StarFormer (K234061) | Fotona D.O.O. | 2024-07-01 |
| Profound Matrix (K240070) | Candela Corporation | 2024-07-01 |
| Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters (K231015) | Innovative Health, LLC | 2024-07-01 |
| FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798) (K232777) | Owens & Minor (O&M) Halyard, Inc. | 2024-07-01 |
| Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML) (K233477) | Shandong Wego Ruisheng Medical Device Co., Ltd. | 2024-07-01 |
| Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) (K232989) | Shenzhen AOJ Medical Technology Co., Ltd. | 2024-07-01 |
| BioSonic US200 Ultrasonic Scaler (60034537) (K240801) | Dent4you AG | 2024-07-01 |
| Electric nasal aspirator (HTD2601US) (K241202) | Hetaida Technology Co., Ltd. | 2024-07-01 |
| Wearable Breast Pump (Model S32) (K240536) | Shenzhen TPH Technology Co., Ltd. | 2024-07-01 |
| BioHealx Anal Fistula Device (DEN240007) | Signum Surgical Limited | 2024-07-01 |
| Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K240477) | St. shine Optical Co., Ltd. | 2024-07-01 |
| cNeuro cDAT (K233908) | Combinostics OY | 2024-07-01 |
| Single-use Video Ureterorenoscope (SVU-220US) (K241639) | Huger Medical Instrument Co., Ltd. | 2024-07-01 |
| SPECTRALIS HRA+OCT and variants (K240221) | Heidelberg Engineering GmbH | 2024-07-01 |
| Hyper Insight - ICH (K240353) | Sk, Inc. | 2024-07-01 |
| ARTFX MEDICAL Cervical PEEK Cages (K240893) | Artfx Medical | 2024-06-28 |
| NovaLine SP-C35 Transducer Protector (956007) (K240164) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 |
| TopCEM-Veneer Light Cure Veneer Cement (K241204) | Rizhao Huge Biomaterials Company, Ltd. | 2024-06-28 |
| Electric Wheelchair (YFWB-63) (K241154) | If Health (Xiamen) Intelligent Technology Co.,Ltd | 2024-06-28 |
| Lavieen (K241406) | Wontech Co., Ltd. | 2024-06-28 |
| Magseed Pro Magnetic Marker System (K232865) | Endomagnetics Ltd., | 2024-06-28 |
| Hello,eyes® BIO Plug (K241229) | Bio Optics Co., Ltd. | 2024-06-28 |
| NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (K241540) | Biosense Webster, Inc. | 2024-06-28 |
| XSense Cryoablation System with Cryoprobes (K240892) | IceCure Medical , Ltd. | 2024-06-28 |
| BLUE 400; BLUE 400 S (K240215) | Carl Zeiss Meditec, AG | 2024-06-28 |
| Ultrasonic Fetal Doppler (K233823) | Shenzhen Jamr Technology Co., Ltd. | 2024-06-28 |
| Cordis BRITECROSS Support Catheter (K233637) | Cordis US Corp | 2024-06-28 |
| Patient Monitor (RespArray) (K240320) | Edan Instruments, Inc. | 2024-06-28 |
| Access Thyroglobulin (K240927) | Beckman Coulter, Inc. | 2024-06-28 |
| nordicMEDiVA (K241608) | Nordicneurolab AS | 2024-06-28 |
| CATALYSTEM Femoral Stems (K240381) | Smith & Nephew, Inc. | 2024-06-27 |
| Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) (K233983) | Edwards Lifesciences | 2024-06-27 |
| FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System (DEN230055) | Balance Ophthalmics, Inc. | 2024-06-27 |
| els extra low shrinkage® composite & els extra low shrinkage® flow (K240823) | Saremco Dental AG | 2024-06-27 |
| UNIKO PointCloud™ Knee Instruments (K240327) | Unik Orthopedics, Inc. | 2024-06-27 |
| Xpert HCV; GeneXpert Xpress System (DEN240016) | Cepheid | 2024-06-27 |
| Annabella Double Breast Pump (ADO-US23-1000) (K241506) | Annabella Tech | 2024-06-27 |
| Pathfinder® CR System (K240853) | Neptune Medical, Inc. | 2024-06-27 |
| MagnetOs Easypack Putty (K241212) | Kuros Biosciences | 2024-06-27 |
| 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) (K241542) | 3M Company | 2024-06-27 |
| Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask (K241520) | Sleepnet Corporation | 2024-06-27 |
| 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K240717) | 3M Company | 2024-06-27 |
| Faros Surgical System (K233398) | Oertli Instrumente AG | 2024-06-27 |
| EsoCool Thermal Regulation Catheter (K233357) | Nuvaira, Inc. | 2024-06-27 |
| SteroScope® Sterilization Technology System (K233762) | Ideate Medical, Inc. | 2024-06-27 |
| Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating (K241553) | Eximo Medical, Ltd. | 2024-06-27 |
| The Optimotion™ Blue Plus Knee System (K240938) | Optimotion Implants, LLC | 2024-06-27 |
| NuFACE® FIX+ (K240564) | Carol Cole Company Dba Nuface® | 2024-06-27 |
| TENS&EMS units (SM9109A, SM9109B) (K241509) | Plexus Yoga, LLC Dba Chirp | 2024-06-27 |
| Magnifico Open (100009900); Magnifico MSK ( 100009910) (K241133) | Esaote, S.p.A. | 2024-06-26 |
| ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) (K241507) | Aln S.A.R.L. | 2024-06-26 |
| Forma Medical Optimal Plating System (K234059) | Forma Medical, Inc. | 2024-06-26 |
| Unity Knee PS-C Tibial Insert (K240875) | Corin U.S.A. Limited | 2024-06-26 |
| SC1 Handheld Ultrasound Imaging system (Model: SC1) (K233579) | Fcu Co., Ltd. | 2024-06-26 |
| Versalock Rib and Sternum Plates System (K232829) | GM Dos Reis Industria e Comercio Ltda. | 2024-06-26 |
| WVSM Pro (Series) (500-0030-XX) (K233354) | Athena Gtx, Inc. | 2024-06-26 |
| Ultraphon Chemical Indicator (TRO-T and TRO-B) (K233413) | True Indicating, LLC | 2024-06-26 |
| TRIDENT Mobile Fluoroscopy System (K233380) | Dornier Medtech America | 2024-06-26 |
| FlowArt Valve for Vial Access (K232987) | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| Sample Preservative Fluid (K222771) | Hangzhou Bioer Technology Co., Ltd. | 2024-06-26 |
| Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) (K233840) | Zhuhai Dipu Medical Technology Co., Ltd. | 2024-06-26 |
| Allograft Delivery Device (OFAC-C) (K233368) | Bioventus, LLC | 2024-06-25 |
| VEA Align; spineEOS (K240582) | Eos Imaging | 2024-06-25 |
| Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) (K240824) | Ningxia Qiaoen Medical Technology Co., Ltd. | 2024-06-25 |
| NeoBeat, NeoBeat Mini (K232111) | Laerdal Medical AS | 2024-06-25 |
| MyndMove, MyndMove 2.0 (K233006) | Myndtec, Inc. | 2024-06-25 |
| ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 (K241158) | Asahi Intecc Co., Ltd. | 2024-06-25 |
| PMT Posterior Cervical Stabilization System (PCSS) (K241035) | Providence Medical Technology, Inc. | 2024-06-25 |
| Venowave VW5 (K232640) | Thermabright | 2024-06-25 |
| Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) (K241120) | Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. | 2024-06-24 |
| Philips IntelliSite Pathology Solution 5.1 (K233204) | Philips Medical Systems Nederland B.V. | 2024-06-24 |
| SILKRO (K233123) | Hironic Co., Ltd. | 2024-06-24 |
| Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 (K233630) | Ambu A/S | 2024-06-24 |
| Copran Zri (K232952) | Whitepeaks Dental Solutions GmbH | 2024-06-24 |
| Picosecond Nd:YAG Laser (PICOCAREMAJESTY) (K241144) | Wontech Co., Ltd. | 2024-06-24 |
| NLZ Built-In Motor System (K233288) | Nakanishi, Inc. | 2024-06-24 |
| APEX 3D Total Ankle Replacement System (K240259) | Paragon 28, Inc. | 2024-06-24 |
| eCARTv5 Clinical Deterioration Suite (“eCART”) (K233253) | Agilemd, Inc. | 2024-06-21 |
| O-arm O2 Imaging System (K240465) | Medtronic Navigation, Inc. | 2024-06-21 |
| MOTUS PRO Family (K241459) | El.En S.P.A. | 2024-06-21 |
| M6-C™ Single Use, Disposable Instrumentation (K241117) | Spinal Kinetics / Orthofix / Seaspine | 2024-06-21 |
| Xerosyn (K233259) | Xerothera, Inc. | 2024-06-21 |
| Invictus® Small Stature Spinal Fixation System (K241519) | Alphatec Spine, Inc. | 2024-06-21 |
| CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (K240728) | CorDx, Inc. | 2024-06-21 |
| Mochida Nerve Cuff (K233322) | Mochida Pharmaceutical Co., Ltd. | 2024-06-21 |
| Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) (K240649) | Shenzhen Ulike Smart Electronics Co., Ltd. | 2024-06-21 |
| Tempus ECG-AF (K233549) | Tempus AI, Inc. | 2024-06-21 |
| OtoNova/OtoNova Pro (K234095) | Otodynamics | 2024-06-21 |
| SteadyTemp (K233280) | Steadysense GmbH | 2024-06-21 |
| ToxiSeal™ Vial Adaptor with External Flip Balloon (K241476) | Epic Medical Pte. , Ltd. | 2024-06-21 |
| MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream (K240643) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 |
| V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System (K240631) | Samsung Medison Co., Ltd. | 2024-06-21 |