| OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail (K231272) | OSSIO , Ltd. | 2023-12-01 |
| BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (K230391) | Becton, Dickinson and Company | 2023-12-01 |
| LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes (K230621) | Surgical Principals, Inc. | 2023-12-01 |
| Antibacterial Gel Wound Dressing (K231057) | Winner Medical Co., Ltd. | 2023-12-01 |
| Comatryx OTC (K232758) | Strukmyer Medical, LLC | 2023-12-01 |
| Medline ComfortTemp Patient Warming System (K231211) | Medline Industries, LP | 2023-12-01 |
| Extension Set (K230528) | Medcaptain Life Science Co., Ltd. | 2023-12-01 |
| Dental Glass Ceramics Blocks (K232438) | Aibodent Biotechnology Co., Ltd. | 2023-12-01 |
| TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System (K231476) | Sinocare, Inc. | 2023-12-01 |
| BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector (K233529) | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-12-01 |
| ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories (K233301) | Lumenis Be, Ltd. | 2023-12-01 |
| pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 (K233159) | Fresenius Medical Care Renal Therapies Group, LLC | 2023-12-01 |
| LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ) (K232262) | Surgease Innovations Limited | 2023-11-30 |
| syngo.CT Dual Energy (K232155) | Siemens Medical Solutions USA, Inc. | 2023-11-30 |
| NavaClick Injection System (K231877) | Lineage Biomedical, Inc. | 2023-11-30 |
| Radical the Dude 7F Guide Catheter (K231393) | Maduro Medical, Inc. | 2023-11-30 |
| Insulin Syringe (K230061) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-11-30 |
| Benesta Tissue Removal Device (K233500) | Caldera Medical, Inc. | 2023-11-30 |
| EPIQ Series Diagnostic Ultrasound System (K233545) | Philips Ultrasound, LLC | 2023-11-30 |
| L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669) | Argon Medical Devices | 2023-11-30 |
| Q-Switched Nd:Yag laser (K232716) | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 |
| Somfit (K231546) | Compumedics Limited | 2023-11-30 |
| Wrist Pulse Oximeter (K230587) | Beijing Choice Electronic Technology Co., Ltd. | 2023-11-30 |
| Diode laser therapy device (K232709) | Hebei Zhemai Technology Co., Ltd. | 2023-11-30 |
| 14F iSLEEVE Introducer Set (K233503) | Boston Scientific Corporation | 2023-11-30 |
| TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (K232611) | Life Spine, Inc. | 2023-11-30 |
| IDEAL Ziploop (K233552) | Riverpoint Medical | 2023-11-30 |
| Auxein's DHS/DCS Plate System (K221787) | Auxein Medical Private Limited | 2023-11-30 |
| Disposable Endoscope Valves System (K232244) | Changzhou Endoclean Medical Device Co., Ltd. | 2023-11-29 |
| Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) (K232772) | Shenzhen Plinma Technology Co. , Ltd. | 2023-11-29 |
| 6440 MyLabX90 (K230179) | Esaote, S.p.A. | 2023-11-29 |
| Surgify Halo (K232684) | Surgify Medical OY | 2023-11-29 |
| Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate (K233527) | Spinal Simplicity, LLC | 2023-11-29 |
| Mosie Baby Kit (K231203) | Mosie Baby | 2023-11-29 |
| CEREGLIDE 92 Intermediate Catheter (K230726) | Cerenovus, Inc. | 2023-11-29 |
| SUREcore Prime Biopsy Instrument (K230646) | Uro-1 Medical, Inc. | 2023-11-29 |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis (K231482) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-11-29 |
| HYBRIDknife® flex (K232033) | Erbe Elektromedizin GmbH | 2023-11-29 |
| XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) (K231821) | Transit Scientific, LLC | 2023-11-29 |
| MULTIX Impact E (K233532) | Siemens Medical Solutions | 2023-11-29 |
| Expandable Lumbar Fusion Cage (Type I,Type II) (K232069) | Shanghai Reach Medical Instrument Co, Ltd. | 2023-11-29 |
| Digital Blood Pressure Monitor (K231250) | Guangdong Genial Technology Co., Ltd. | 2023-11-28 |
| Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter (K232633) | Boston Scientific | 2023-11-28 |
| Monarch Bronchoscope (K231473) | Auris Health, Inc., A Johnson and Johnson Family Company | 2023-11-28 |
| BriefCase-Quantification (K231631) | Aidoc Medical , Ltd. | 2023-11-28 |
| Cue COVID-19 Molecular Test (K232643) | Cue Health, Inc. | 2023-11-28 |
| Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece (K222845) | Frey Oral Technologies, LLC | 2023-11-28 |
| Shoreline ACS Interbody System; Shoreline RT Interbody System (K233414) | SeaSpine Orthopedics Corporation | 2023-11-28 |
| Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) (K233493) | Relign Corporation | 2023-11-28 |
| Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) (K232117) | Wuhan Lotuxs Technology Co., Ltd. | 2023-11-28 |
| syngo.via MI Workflows; Scenium; syngo MBF (K232000) | Siemens Medical Solutions USA, Inc. | 2023-11-28 |
| VersaPump Infusion System (K230883) | Emed Technologies Corporation | 2023-11-28 |
| Kinos Axiom Total Ankle System (K232595) | Restor3D | 2023-11-28 |
| C.A.R.E. Appliance (DNA, mRNA, mmRNA) (K230947) | Vivos Therapeutics, Inc. | 2023-11-28 |
| Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) (K232252) | Dehai (Shandong) Medical Gloves, Co., Ltd. | 2023-11-28 |
| N1 (K232012) | Osstem Implant Co., Ltd. | 2023-11-28 |
| Blood Pressure Monitor (K232713) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-28 |
| Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (K232222) | Medency S.R.L. | 2023-11-27 |
| ABPMpro (K231104) | Somnomedics GmbH | 2023-11-27 |
| Statera-C™ Spinal System (K233332) | K&J Consulting Corp. | 2023-11-27 |
| CardioPhase® hsCRP (K232624) | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 |
| PF Keep; Cad Cam Keep Block (K233171) | Clemde SA DE CV | 2023-11-27 |
| T-Top 10 & T-Top T-Top 11 (K232658) | Tuttnauer U.S.A Co, Ltd. | 2023-11-27 |
| Portable (Ultrasonic) Nebulizer (K230379) | Dongguan Simzo Electronic Technology Co., Ltd. | 2023-11-27 |
| BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube (K230493) | Becton, Dickinson and Company | 2023-11-27 |
| CryoThin™ Surgical System and Accessories (K231661) | Medinux (Tianjin) Technologies Co., Ltd. | 2023-11-27 |
| ClearPoint System (Software Version 2.2) (K233243) | ClearPoint Neuro, Inc. | 2023-11-27 |
| SteriCap Safety Needle; VitreJect Safety Needle (K233343) | Ocuject, LLC | 2023-11-27 |
| NeuTrace EP Mapping System v.2.1 (K233160) | Anumana, Inc. | 2023-11-25 |
| HyperSuture (K230311) | Threadstone, LLC | 2023-11-24 |
| Passio Pump Drainage System (K230319) | Bearpac Medical | 2023-11-24 |
| Stim2Go (K230701) | PAJUNK GmbH Medizintechnologie | 2023-11-24 |
| Tympanostomy Tubes (K232059) | Grace Medical, Inc. | 2023-11-24 |
| MF SC Facial Toning System (K233525) | Micro Current Technology, Inc. | 2023-11-24 |
| Blood pressure monitor (K232621) | Guangdong Transtek Medical Electronics Co., Ltd. | 2023-11-22 |
| Posterior Cervical Spine System (K233078) | Double Medical Technology, Inc. | 2023-11-22 |
| Carnation Ambulatory Monitor (K233110) | Bardy Diagnostics, Inc. | 2023-11-22 |
| Fogg System Patient Monitoring Cables (K222712) | Fogg System Company, Inc. | 2023-11-22 |
| IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) (K232635) | Boston Scientific | 2023-11-22 |
| IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) (K230604) | Philips Medizin Systeme Boeblingen GmbH | 2023-11-22 |
| DxFLEX Flow Cytometer; ClearLLab 10C Panels (K232600) | Beckman Coulter, Inc. | 2023-11-22 |
| Medifun Lancing Device, Model No. LD-E1 (K231797) | Medifun Corporation | 2023-11-22 |
| HealiAid Dental Collagen Wound Dressing (K230529) | Maxigen Biotech, Inc. | 2023-11-22 |
| Disposable Endoscope Valves Kit (K222499) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2023-11-22 |
| Digital Blood Pressure Monitor (Arm Type) (K231245) | Guangdong Genial Technology Co., Ltd. | 2023-11-22 |
| FITme Customized Silicone Implant (K232593) | Keosan Trading Co. | 2023-11-22 |
| CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (K230834) | Trismed Co., Ltd. | 2023-11-21 |
| PNK Total Knee System (K231975) | Tjc Life Co., Ltd. | 2023-11-21 |
| NemoCast (K232549) | Software Nemotec S.L. | 2023-11-21 |
| Absorbable Cranial Flap Fixation System (K221606) | Chendu Medart Medical Scientific Co., Ltd. | 2023-11-21 |
| Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system (K233084) | Gbs Commonwealth Co., Ltd. | 2023-11-21 |
| High Pressure Tubing (K232388) | Ningbo Dizegens Medical Science Co.,Ltd | 2023-11-21 |
| Endoscopy Irrigation Tubing (K230773) | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 |
| TotalTi ACDF by SAGICO (K233191) | Spinal Analytics & Geometrical Implant Co, LLC | 2023-11-21 |
| CranioXpand (K230211) | KLS-Martin L.P. | 2023-11-21 |
| Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System (K232988) | Canon Medical Systems Corporation | 2023-11-21 |
| Digital ClarusScope System, Digital NeuroPEN System (K223615) | Clarus Medical, LLC | 2023-11-21 |
| Oxy2Pro (K222511) | Southmedic, Inc. | 2023-11-21 |
| INFINITI™ Ambi Angiographic Catheter (K232573) | Cordis US Corp | 2023-11-21 |
| Mini-OSTEO Pedicle Fixation System (K231443) | Osteomed Indústria E Comércio DE Implantes Ltda | 2023-11-21 |