| G4Derm / G4Derm Plus Synthetic Wound Matrix (K222025) | Gel4med, Inc. | 2023-10-11 |
| VASSALLO GT 018 G12; VASSALLO GT 018 G30 (K232578) | Filmec Co. , Ltd. | 2023-10-11 |
| ID NOW Influenza A & B 2 (K232775) | Abbott Diagnostics Scarborough, Inc. | 2023-10-10 |
| Zeus Spinal System (K230961) | Shanghai Sanyou Medical Co, Ltd. | 2023-10-10 |
| IPD Dental Implant Abutments (K231413) | Implant Protesis Dental 2004, S.L. | 2023-10-10 |
| WeSensor (K230916) | Picopack, Inc. | 2023-10-10 |
| VEOS Spinal Fixation System (K231658) | Spineway | 2023-10-10 |
| CarboClear® Pedicle Screw System (K232341) | CarboFix Orthopedics , Ltd. | 2023-10-10 |
| NeuroTrigger Basic (NTB) (K223027) | Neurotrigger | 2023-10-10 |
| Vy Spine™ VyLam™ Laminoplasty System (K232471) | Vy Spine, LLC | 2023-10-10 |
| Micromate™ Navi+ (K230130) | Isys Medizintechnik GmbH | 2023-10-10 |
| Patient Examination Gloves (K230777) | 3A Glove Sdn. Bhd. | 2023-10-06 |
| Invictus Robotic Navigation Instruments (K232044) | Alphatec Spine, Inc. | 2023-10-06 |
| Cautery Protective Actuation System (CPAS) (K232407) | Safer Surgeries Medical Devices, LLC | 2023-10-06 |
| Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 (K232276) | Oxoid Limited (Part of Thermo Fisher Scientific) | 2023-10-06 |
| Nutricair Enteral Syringe with ENFit (K231300) | Cair Lgl | 2023-10-06 |
| Vivio® LVEDP System (K223905) | Avicena, LLC | 2023-10-06 |
| 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomposite Anchor (K232492) | Medos International SARL | 2023-10-06 |
| Ascend VBR System, Ascend NanoTec VBR System (K232173) | Alphatec Spine, Inc. | 2023-10-06 |
| Vial Adapter (K232055) | Shanghai Lingfu Technology Co., Ltd. | 2023-10-06 |
| Edison System (DEN220087) | HistoSonics, Inc. | 2023-10-06 |
| accufit (K223802) | Mettler Electronics Corporation | 2023-10-06 |
| Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (K232046) | Xeridiem Medical Devices, A Spectrum Plastics Group Company | 2023-10-06 |
| JuggerKnot Soft Anchor OC (K232411) | Riverpoint Medical, LLC | 2023-10-06 |
| Standard Staple-Line Reinforcement (SSLR23) (K231603) | Standard Bariatrics, Inc. | 2023-10-06 |
| Swoop® Portable MR Imaging System® (K232760) | Hyperfine, Inc. | 2023-10-06 |
| THE Cover (K230091) | Purgo Biologics, Inc. | 2023-10-06 |
| IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 (K232056) | Dongguan Lide Electric Appliance Co., Ltd. | 2023-10-06 |
| ProBeam 360° Proton Therapy System v2.0 (Multiroom) (K231863) | Varian Medical Systems, Inc. | 2023-10-06 |
| ScanNav Anatomy Peripheral Nerve Block (K232787) | Intelligent Ultrasound Limited | 2023-10-06 |
| VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box (K223926) | Medimaging Integrated Solution, Inc (Miis) | 2023-10-06 |
| MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (K230265) | Infobionic, Inc. | 2023-10-06 |
| EARP Nerve Cuff Electrode (K230853) | Nvision Biomedical Technologies, Inc. | 2023-10-06 |
| Disposable Sterile Syringe (K221777) | Weihai Shengjie Medical Technology Co., Ltd. | 2023-10-06 |
| ProtekDuo Veno-Venous Cannula Sets (K232480) | Cardiacassist, Inc. | 2023-10-06 |
| Denti.AI Detect (K230144) | Denti.Ai Technology, Inc. | 2023-10-06 |
| Arthrex FiberTape and TigerTape Cerclage Sutures (K232755) | Arthrex, Inc. | 2023-10-06 |
| ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395) | Biomérieux | 2023-10-05 |
| Clarius Ultrasound Scanner (K232704) | Clarius Mobile Health Corp. | 2023-10-05 |
| Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (K220451) | Randox Laboratories Limited | 2023-10-05 |
| Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) (K223740) | Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. | 2023-10-05 |
| DeepTek CXR Analyzer v1.0 (K231001) | Deeptek Medical Imaging Pvt, Ltd. | 2023-10-05 |
| LifeStyles NRL Textured Condom (K232279) | Suretex Limited | 2023-10-05 |
| MFG-05 (K230780) | Zimmer Medizinsysteme GmbH | 2023-10-05 |
| MESORAM® Hypodermic Needle (710301); MESORAM® Hypodermic Needle (710302); MESORAM® Hypodermic Needle (712305); MESORAM® Hypodermic Needle (712315); MESORAM® Hypodermic Needle (710303); MESORAM® Hypodermic Needle (710307); MESORAM® Hypodermic Needle (710306); MESORAM® Hypodermic Needle (712308); MESORAM® Hypodermic Needle (712318); MESORAM® Hypodermic Needle (712303); MESORAM® Hypodermic Needle (712307); MESORAM® Hypodermic Needle (712306); MESORAM® Hypodermic Needle (812400); MESORAM® (K230070) | Promamedical, Inc. | 2023-10-05 |
| OsteoCentric Dental Implant System (K230242) | OsteoCentric Technologies | 2023-10-05 |
| Heating Tens, FT-615 (K232675) | Hivox Biotek, Inc. | 2023-10-05 |
| cmAngio® V1.0 (K232367) | Curemetrix, Inc. | 2023-10-05 |
| Evidence MultiSTAT DOA Urine MultiPlex (K221550) | Randox Laboratories Limited | 2023-10-05 |
| Tandem Mobi insulin pump with interoperable technology (K233044) | Tandem Diabetes Care, Inc. | 2023-10-05 |
| All-Suture Anchor (K231078) | Riverpoint Medical, LLC | 2023-10-05 |
| DuraGraft (DEN230002) | Marizyme, Inc. | 2023-10-04 |
| EFAI NeuroSuite CT ICH Assessment System (K231025) | Ever Fortune.Ai, Co., Ltd. | 2023-10-04 |
| VUNO Med-DeepBrain (K231398) | Vuno, Inc. | 2023-10-04 |
| The IQoolTM System (K232844) | Braincool AB | 2023-10-04 |
| Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) (K231567) | Better Care Plastic Technology Co., Ltd. | 2023-10-04 |
| Electrode Handpieces (VCT, RFTV, BMDT series) (K232763) | RF Medical Co., Ltd. | 2023-10-04 |
| Nautilus VF ECMO Oxygenator (K232767) | Mc3, Inc. | 2023-10-04 |
| Momentum Spine (K232023) | Momentum Health, Inc. | 2023-10-04 |
| Copioumed Chemotherapy Isolation Gown (K230135) | Copioumed International, Inc. | 2023-10-04 |
| V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System (K231772) | Samsung Medison Co., Ltd. | 2023-10-03 |
| uMI Panorama (K232712) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-10-03 |
| enspire 300 Series Automated Endoscope Reprocessor (K232918) | STERIS Corporation | 2023-10-03 |
| KARL STORZ OR1™ SCB CONTROL (WU300) (K232406) | Karl Storz SE & CO. KG | 2023-10-03 |
| Lung-CAD (K230085) | Imagen Technologies, Inc. | 2023-10-03 |
| YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) (K232230) | Zhenjiang Assure Medical Equipment Co., Ltd. | 2023-10-03 |
| SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (K232914) | STERIS Corporation | 2023-10-03 |
| dS Breast Coil 7ch 1.5T (K232762) | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 |
| NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether (K231960) | Anx Robotica Corporation | 2023-10-03 |
| Orchid Safety Release ValveTM (K232094) | Linear Health Sciences, LLC | 2023-10-03 |
| endo.digital Platform (K232722) | DreaMed Diabetes, Ltd. | 2023-10-03 |
| OsteoFlo® HydroPutty™ (K231716) | SurGenTec, LLC | 2023-10-02 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl (K230681) | Central Medicare Sdn Bhd | 2023-10-02 |
| tmCMF Solution (K231520) | Techmah Cmf | 2023-10-02 |
| Surgical face mask (K232359) | Kingstar Medical (Xianning) Co., Ltd. | 2023-10-02 |
| Warantec Custom Abutment (K221972) | Warantec Co., Ltd. | 2023-10-02 |
| Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) (K232064) | Isikel Manufacturing, LLC | 2023-10-02 |
| Elecsys Tg II (K221890) | Roche Diagnostics | 2023-09-30 |
| Microcatheter (K232647) | Surmodics,Inc. | 2023-09-29 |
| Chemotherapy Gloves (K230847) | 3A Glove Sdn. Bhd. | 2023-09-29 |
| PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove (K231973) | Ineo Tech Sdn Bhd | 2023-09-29 |
| 3M™ Clarity™Aligners with Quick Attachments (K233257) | 3M Company, Unitek Orthodontic Products | 2023-09-29 |
| Intraosseous Fusion Device System (K231649) | Auxano Medical, LLC | 2023-09-29 |
| Invitae Common Hereditary Cancers Panel (DEN210011) | Invitae Corporation | 2023-09-29 |
| WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet (K231702) | OTU Medical, Inc. | 2023-09-29 |
| Miris Human Milk Analyzer (HMA) (K223085) | Miris AB | 2023-09-29 |
| Procise ADL (DEN220023) | Procisedx, Inc. | 2023-09-29 |
| BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K232651) | Boston Scientific Corporation | 2023-09-29 |
| REGER Nebulizer Irrigation Cannula (K231622) | Reger Medizintechnik, GmbH | 2023-09-29 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| DYNEX SmartPLEX MMRV IgG Assay Kit (K212769) | Dynex Technologies, Inc. | 2023-09-29 |
| StarFormer, TightWave (K221274) | Fotona D.O.O. | 2023-09-29 |
| SafeBreak® Vascular (K231957) | Lineus Medical | 2023-09-29 |
| Aptiva CTD Essential Reagent (K213403) | Inova Diagnostics, Inc. | 2023-09-29 |
| Terran NM-101 (K230187) | Terran Biosciences, Inc. | 2023-09-29 |
| TriLEAP Plating System (K230591) | Crossroads Extremity Systems | 2023-09-29 |
| AnemoCheck Home (K221508) | Sanguina, Inc. | 2023-09-29 |
| Antibacterial bandage (K221570) | Allmed Medical Products Co., Ltd. | 2023-09-29 |
| TriALTIS Navigation Enabled Instruments (K231527) | Medos International Sàrl | 2023-09-29 |
| HipCheck (K230045) | Stryker Corp. | 2023-09-29 |