| 3D-SHAPER (K220822) | 3D-Shaper Medical S.L | 2022-12-09 |
| LIAISON Anti-HAV; LIAISON XS (K223403) | DiaSorin, Inc. | 2022-12-09 |
| AIROS 8P Sequential Compression Device (K223193) | Airos Medical, Inc. | 2022-12-09 |
| SeaSpine 7D Navigation Instruments (K222753) | SeaSpine Orthopedics Corporation | 2022-12-09 |
| Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate (K222650) | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 |
| FloPatch FP120 (K222242) | Flosonics Medical | 2022-12-09 |
| InkSpace Imaging Body Array (K223487) | Inkspace Imaging, Inc. | 2022-12-08 |
| LED Curing Light (K220826) | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 |
| Oxygen Concentrator, Model JAY-5AW (K213210) | Longfian Scitech Co., Ltd. | 2022-12-08 |
| 8ch Wrist Coil (K223239) | Shenzhen RF Tech Co., Ltd. | 2022-12-08 |
| IRRAflow Active Fluid Exchange System (AFES) (K222471) | Irras USA | 2022-12-08 |
| CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System (K222038) | Abbott (Formerly Thoratec Corporation) | 2022-12-08 |
| YY-A02-B Overlapped Compression Therapy (K221862) | Huizhou Xinyi Technology Co., Ltd. | 2022-12-08 |
| MAVERICK Mini External Fixation System (K223112) | Smith & Nephew, Inc. | 2022-12-08 |
| Sleeved IC (K220667) | Hollister Incorporated | 2022-12-08 |
| LED Eye Perfector, model: EY-36A, EY-36B (K221444) | Light Tree Ventures Europe B.V. | 2022-12-08 |
| Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters (K222837) | Spectranetics, Inc. | 2022-12-08 |
| Southern Transforaminal Lumbar Interbody Fusion (TLIF) (K221182) | Southern Medical (Pty) , Ltd. | 2022-12-08 |
| Yomi Robotic System (K222750) | Neocis, Inc. | 2022-12-08 |
| Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer (K211800) | Quality IN Flow , Ltd. | 2022-12-08 |
| Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) (K223394) | Visionary Optics, LLC | 2022-12-07 |
| Cios Select (VA21) Flat Panel (K223410) | Siemens Medical Solutions USA, Inc. | 2022-12-07 |
| Disposable Nitrile Examination Glove (K223281) | Anhui Kindguard Medical Supplies Technology Co., Ltd. | 2022-12-07 |
| Ultrasound System 2300 (K222441) | Bk Medical Aps | 2022-12-07 |
| HydroMID 4F Single Lumen Midline Catheter (K220772) | Access Vascular, Inc. | 2022-12-07 |
| 3-Ply Disposable Medical Mask (K223045) | Wealth Lead Industrial Limited | 2022-12-07 |
| ViewFlex Xtra ICE Catheter (K223077) | Irvine Biomedical, A St. Jude Medical Company | 2022-12-07 |
| OAKTREE Anterior Lumbar Plate and Screw System (K220843) | Oak Tree Engineering, LLC | 2022-12-07 |
| Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate (K221626) | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2022-12-07 |
| Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF (K221842) | Roche Diagnostics | 2022-12-07 |
| PVC Hydrophilic Urethral Catheter (K212567) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 2022-12-07 |
| Dexcom G7 Continuous Glucose Monitoring System (K213919) | Dexcom, Inc. | 2022-12-07 |
| Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus (K221836) | Drägerwerk AG & Co. KGaA | 2022-12-07 |
| Premier's MultiMatch Universal Chameleon Restorative Composite (K223632) | Premier Dental Products Company | 2022-12-06 |
| Optima Coil System (K223386) | Balt USA, LLC | 2022-12-06 |
| Cios Select (VA21) Image Intensifier (K223409) | Siemens Medical Solutions USA, Inc. | 2022-12-06 |
| Dental Zirconia Ceramic (K222626) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2022-12-06 |
| Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (K222541) | Bausch & Lomb, Incorporated | 2022-12-06 |
| MedDream (K222320) | Softneta Uab | 2022-12-06 |
| HurriChem Device Kit (K222575) | Thermasolutions, LLC | 2022-12-06 |
| Swoop Portable MR Imaging System (K223247) | Hyperfine, Inc. | 2022-12-06 |
| iCE-SG2 Subcutaneous Electrode Kit (K222706) | Ice Neurosystems, Inc. | 2022-12-06 |
| Femoral Trochanteric Nail System – Neonail (K221021) | Neoortho Produtos Ortopédicos S/A | 2022-12-06 |
| R2 Studio Q/RCT820 (K222219) | Megagen Implant Co., Ltd. | 2022-12-06 |
| Bifurcated Needle (K222385) | Anhui Tiankang Medical Technology Co., Ltd. | 2022-12-06 |
| Cryopush Cold Compression Device (K222669) | Chengdu Cryo-Push Medical Technology Co.,Ltd | 2022-12-05 |
| BPAP System (K213169) | BMC Medical Co., Ltd. | 2022-12-05 |
| Mallya Injection Pen Adapter (Mallya® for Solostar®) (K222689) | Biocorp Production | 2022-12-05 |
| Zavation Spinal System (K222614) | Zavation Medical Products, LLC | 2022-12-05 |
| Altaviz Needle Kit (K222681) | Altaviz, LLC | 2022-12-05 |
| TruLift Lateral Expandable Spacer System & Lateral Plate System (K221806) | Life Spine, Inc. | 2022-12-05 |
| ClearRead CT (K221612) | Riverain Technologies, Inc. | 2022-12-05 |
| BriefCase (K222692) | Aidoc Medical , Ltd. | 2022-12-05 |
| OK Plus Indicator (K222137) | Propper Manufacturing Co., Inc. | 2022-12-05 |
| Disposable Medical Face Mask (K223055) | Xiantao Zhuobo Industrial Co., Ltd. | 2022-12-05 |
| Disposable Nitrile Examination Gloves (K223004) | Jiangxi Handspro Products Solutions Co., Ltd. | 2022-12-04 |
| 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) (K222019) | Stryker Sustainability Solutions | 2022-12-04 |
| Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl (K222815) | Zibo Lanhua Medical Packaging Material Co., Ltd. | 2022-12-04 |
| Black Nitrile Powder Free Patient Examination Glove, Non Sterile (K222715) | Safeskin Retailing (Hk) Limited | 2022-12-03 |
| truSculpt flex (K212866) | Johari Digital Healthcare Limited | 2022-12-03 |
| Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K222720) | Safeskin Retailing (Hk) Limited | 2022-12-03 |
| White Nitrile Powder Free Patient Examination Glove, Non Sterile (K222713) | Safeskin Retailing (Hk) Limited | 2022-12-03 |
| SUREcore Plus Biopsy Instrument (K220611) | Uro-1, Inc. | 2022-12-02 |
| CreoDent Solidex Customized Abutment and Screw (K220390) | Creodent Prosthetics, Ltd. | 2022-12-02 |
| Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor (K221113) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2022-12-02 |
| PENTAX Medical Video Esophagoscope EE17-J10 (K223072) | Pentax of America, Inc. | 2022-12-02 |
| SilentZPro 2.0 (K220688) | Shinrin-Yoku Traders, LLC | 2022-12-02 |
| truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184 (K223369) | STERIS Corporation | 2022-12-02 |
| Maestro Platform (K221410) | Moon Surgical | 2022-12-02 |
| Parietene Macroporous Mesh (K223218) | Sofradim Production | 2022-12-02 |
| INHANCETM Shoulder System – Humeral Stems and Stemless (K223211) | Depuy Ireland UC | 2022-12-02 |
| Chemical Indicator for Steam (K220778) | True Indicating, LLC | 2022-12-02 |
| CardioGraphe (K213465) | Arineta , Ltd. | 2022-12-02 |
| PageWriter TC35 Cardiograph (K221141) | Medizin Systeme Boblingen GmbH | 2022-12-02 |
| NaviCam Small Bowel Capsule Endoscopy System (K221590) | Ankon Technologies Co., Ltd. | 2022-12-02 |
| Self-Cath and Self-Cath Plus (K221401) | Coloplast | 2022-12-02 |
| DropSafeTM SicuraTM (K223353) | Pikdare Spa | 2022-12-02 |
| STAR Apollo Mapping System (K220786) | Rhythm Al, Ltd. | 2022-12-01 |
| 2-Way 100% Silicone Cleartract Catheter (K222118) | Silq Technologies, Corp. | 2022-12-01 |
| ProBeam 360° Proton Therapy System (K221791) | Varian Medical Systems, Inc. | 2022-12-01 |
| Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G (K222125) | Shenzhen AOJ Medical Technology Co., Ltd. | 2022-12-01 |
| IPL Cooling Hair Removal Device (K222710) | Shenzhen Siken 3D Technology Development Co., Ltd. | 2022-12-01 |
| Chartis Precision Catheter (K222340) | Pulmonx Corporation | 2022-12-01 |
| Trigon™ HA Stand-Alone Wedge Fixation System (K223226) | Nvision Biomedical Technologies, Inc. | 2022-12-01 |
| Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs (K221747) | Fitone Latex Products Co., Ltd. Guangdong | 2022-12-01 |
| MIST IC (K222368) | Imagine Milling Technologies, LLC | 2022-12-01 |
| Bolt Navigation System (K213768) | Circinus Medical Technology, LLC | 2022-12-01 |
| Mercury® II Spinal System (K222516) | Spinal Elements, Inc. | 2022-12-01 |
| CentriMag Pre-connected Pack (K222297) | Abbott | 2022-12-01 |
| MissLan™ Digital Pregnancy Rapid Test (K222305) | Guangzhou Decheng Biotechnology Co., Ltd. | 2022-11-30 |
| Steripath Micro Blood Collection System (K222299) | Magnolia Medical Technologies | 2022-11-30 |
| Lancing System, Sterile Lancet for Single Use, Lancing Device (K222472) | Shandong Lianfa Medical Plastic Products Co. , Ltd. | 2022-11-30 |
| Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl (K221082) | Rhino Health, Inc. | 2022-11-30 |
| Elos Accurate Customized Abutment (K222044) | Elos Medtech Pinol A/S | 2022-11-30 |
| EEA Circular Stapler with Tri-Staple Technology (K221771) | Covidien | 2022-11-30 |
| Neuron-Spectrum-AM with Neuron-Spectrum.NET Software (K220254) | Neurosoft , Ltd. | 2022-11-30 |
| Purgo (K223328) | Aeroclean Technologies, Inc. | 2022-11-30 |
| Paneffort AAMI Level 3 Isolation Gown (K212717) | Paneffort, LLC | 2022-11-30 |
| Disposable Safety Lancet (K222408) | Beijing Ruicheng Medical Supplies Co., Ltd. | 2022-11-29 |
| Signia™ Small Diameter Reloads Including Regular (Round) Tip Version (K222641) | Covidien | 2022-11-29 |