| Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) (K210122) | Osteonic Co., Ltd. | 2021-08-27 |
| AcQMap High Resolution Imaging and Mapping System (K212345) | Acutus Medical, Inc. | 2021-08-27 |
| PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E (K211684) | Given Imaging Ltd. (Medtronic) | 2021-08-27 |
| RBknee (K203696) | Radiobotics Aps | 2021-08-27 |
| Needle Stimulator (K202861) | Wuxi Jiajian Medical Instrument Co., Ltd. | 2021-08-27 |
| Stiletto Extended Dwell Catheter (K210047) | Piper Access, LLC | 2021-08-27 |
| Neuspera Neurostimulation System (NNS) (K202781) | Neuspera Medical, Inc. | 2021-08-27 |
| BEE PLIF Cage (K211413) | NGMedical GmbH | 2021-08-27 |
| MyoSPECT, MyoSpect ES (K212004) | GE Healthcare | 2021-08-27 |
| K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K212038) | K&J Consulting Corporation | 2021-08-27 |
| Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System (DEN200064) | Canary Medical, Inc. | 2021-08-27 |
| SOLOPASS System (K203251) | Intravent Medical Partners, LP | 2021-08-27 |
| Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large (K212355) | Checkpoint Surgical | 2021-08-26 |
| Hypodermic Needle-Pro EDGE Safety Device (K211634) | Smiths Medical Asd, Inc. | 2021-08-26 |
| TT Electric Breast Pump, TT Double Electric Breast Pump (K202802) | Wuxi Xinzhongrui Baby Supplies Co., Ltd. | 2021-08-26 |
| Heel Incision Safety Lancet (K210745) | SteriLance Medical (Suzhou), Inc. | 2021-08-26 |
| Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) (K210898) | Tangshan Lanhai Medical Supplies Co., Ltd. | 2021-08-26 |
| ComfortGuard Surgical Isolation Gown (K210131) | Gri-Alleset, Inc. | 2021-08-26 |
| ViperCross Support Catheters (K211240) | Cardiovascular Systems, Inc. | 2021-08-26 |
| The iMask Child's Face Mask (K202831) | Pac-Dent, Inc. | 2021-08-26 |
| Aptiva Celiac Disease IgG Reagent (K200230) | Inova Diagnostics, Inc. | 2021-08-26 |
| Disposable Manual Resuscitator (K210288) | Xiamen Compower Medical Tech. Co., Ltd. | 2021-08-26 |
| Disposable Sterile Syringe, Disposable Sterile Syringe with Needle (K210991) | Guangdong Antmed Co., Ltd. | 2021-08-26 |
| Amber Mill Q Series & Amber Mill Direct Series (K202952) | Hass Corp. | 2021-08-26 |
| Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) (K212048) | Intuitive Surgical, Inc. | 2021-08-26 |
| Visby Medical Sexual Health (K200748) | Visby Medical | 2021-08-26 |
| Premilled Titanium Block System (K203344) | Innobiosurg Co., Ltd. | 2021-08-25 |
| RFA-1717DIG, RFA-1717DIC (K212051) | Astel, Inc. | 2021-08-25 |
| SCAR 3 (K211362) | El.En Electronic Engineering Spa | 2021-08-25 |
| CellFX System (K211444) | Pulse Biosciences, Inc. | 2021-08-25 |
| Elvie Stride (K210936) | Chiaro Technology Limited | 2021-08-25 |
| Auxein Nailing System (K210792) | Auxein Medical Private Limited | 2021-08-25 |
| Lateralized and Augmented Baseplates (K210790) | Fx Shoulder USA, Inc. | 2021-08-25 |
| Diagnostic X-ray System/PLX5200A (K212134) | Nanjing Perlove Medical Equipment Co., Ltd. | 2021-08-25 |
| AMSCO 600 Medium Steam Sterilizer (K211500) | STERIS Corporation | 2021-08-25 |
| ExcelsiusHub (K211616) | Globus Medical, Inc. | 2021-08-25 |
| Balloon Guiding Catheter (K202916) | Shanghai Heartcare Medical Technology Co., Ltd. | 2021-08-25 |
| Instinct Plus Endoscopic Clipping Device (K212323) | Wilson-Cook Medical, Inc. | 2021-08-25 |
| Disposable Surgical Mask (non sterile) (K211451) | Qinhuangdao Taizhi Medical Technology Co., Ltd. | 2021-08-25 |
| PROWLER SELECT PLUS; PROWLER EX (K210838) | Medos International SARL | 2021-08-25 |
| E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) (K202148) | Fit-Pro , Ltd. | 2021-08-25 |
| HVT 2.0 (K203357) | Vapotherm, Inc. | 2021-08-25 |
| ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert (K211609) | Depuy Ireland UC | 2021-08-25 |
| ELAN 4 Electro Motor System (K203739) | Aesculap, Inc. | 2021-08-24 |
| Disposable Nitrile Examination Gloves (K210897) | Shandong DS Safety Technology Co., Ltd. | 2021-08-24 |
| SKR 3000 (K210619) | Konica Minolta, Inc. | 2021-08-24 |
| Shoulder Pacemaker (K210674) | Ncs Lab Srl | 2021-08-24 |
| TurboHawk Plus Directional Atherectomy System (K212027) | Medtronic, Inc. | 2021-08-24 |
| DreamWear Silicone Pillows Mask (K210844) | Respironics, Inc. | 2021-08-24 |
| Advantage-C PEEK Cervical lnterbody Fusion Device (K211501) | Lntelivation, LLC | 2021-08-24 |
| Prime BIOFOAM® Multi-Hole Shells (K201157) | Microport Orthopedics, Inc. | 2021-08-24 |
| Auto Disable Syringe (K210464) | Anhui Tiankang Medical Technology Co., Ltd. | 2021-08-24 |
| Disposable Vinyl Nitrile Synthetic Gloves Powder Free (K211516) | Tangshan Hongyun Plastic Products Co., Ltd. | 2021-08-24 |
| Nitrile Examination Gloves (K211515) | Beijing Reagent Latex Products Co., Ltd. | 2021-08-24 |
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |
| IMRIS iMRI 3T V (K212367) | Deerfield Imaging, Inc. | 2021-08-23 |
| Disposable medical face mask (K202745) | Ningbo Jingeao Electronics, Inc. | 2021-08-23 |
| EzOrtho (K211793) | Ewoosoft Co., Ltd. | 2021-08-23 |
| npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ (K201400) | Aatru Medical, LLC | 2021-08-23 |
| CLAREON MONARCH IV IOL Delivery System (K212039) | Alcon Laboratories, Inc. | 2021-08-23 |
| DEKA SMARTPERIO (K203396) | El.En Electronic Engineering Spa | 2021-08-23 |
| 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF (K212105) | Pzmedical Technology Co., Ltd. | 2021-08-23 |
| RenovoCath (K212324) | Renovorx, Inc. | 2021-08-23 |
| SmartGuard Anti-Snoring Device (K200657) | Smartguard Rx, Inc. | 2021-08-23 |
| Disposable Surgical Gowns (K202532) | Anhui Medpurest Medical Technology Co.,Ltd | 2021-08-21 |
| BC Reflex Uni Knee System (K211895) | Bodycad Laboratories, Inc. | 2021-08-20 |
| Nam illumination probe with chopper (K202670) | Oculight , Ltd. | 2021-08-20 |
| Simplify Disc (K211757) | Nuvasive, Inc. | 2021-08-20 |
| Exo Iris (K211527) | Exo Imaging, Inc. | 2021-08-20 |
| IPS e.max One (K211916) | Ivoclar Vivadent, AG | 2021-08-20 |
| Discovery MI Gen2 (K211846) | Ge Medical Systems, LLC | 2021-08-20 |
| Prime and DYNASTY® Additive Manufacturing Shells (K202705) | Microport Orthopedics, Inc. | 2021-08-20 |
| Omni Foot and Ankle Plating System (K212297) | Extremity Medical, LLC | 2021-08-20 |
| ADVIA Centaur Enhanced Liver Fibrosis (ELF) (DEN190056) | Siemens Healthcare Diagnostics, Inc. | 2021-08-20 |
| Molekule Air Pro (K211194) | Molekule, Inc. | 2021-08-20 |
| Medical Gloves (K203622) | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | 2021-08-20 |
| Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (K201857) | Careplus (M) Sdn Bhd | 2021-08-20 |
| IO Expandable Lumbar Interbody Fusion System (K210800) | MiRus, LLC | 2021-08-20 |
| Ez3D-i/E3 (K211791) | Ewoosoft Co., Ltd. | 2021-08-20 |
| Auxilock Titanium Interference Screw (K203029) | Auxein Medical Private Limited | 2021-08-20 |
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |
| Inset Reverse Total Shoulder System (K210533) | Shoulder Innovations, Inc. | 2021-08-20 |
| Altus Spine Sochi OCT Spinal System (K210887) | Altus Partners, LLC | 2021-08-20 |
| Otoplan (K203486) | Cascination AG | 2021-08-20 |
| Wishbone HA (K211551) | Wishbone SA | 2021-08-20 |
| Ethos Treatment Management, Ethos Treatment Planning (K212294) | Varian Medical Systems, Inc. | 2021-08-20 |
| MOSS VRS Spinal System (K203607) | Biedermann Motech GmbH & Co. KG | 2021-08-20 |
| Nitrile Exam Gloves, Powder Free, Blue (K211699) | Hengchang (Dongying) Medical Technology Co., Ltd. | 2021-08-20 |
| Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) (K203705) | Careplus (M) Sdn Bhd | 2021-08-20 |
| Purism Non-Sterile Powder Free Nitrile Examination Gloves (K211319) | Dezhou Purism Medical Technology Co., Ltd. | 2021-08-19 |
| Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 (K211066) | Homtex, Inc. | 2021-08-19 |
| ECOMA Level 2 Disposable Surgical Mask with Ear Loops (K210698) | Xianning Eco Medical Articles Co., Ltd. | 2021-08-19 |
| Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System (K210317) | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2021-08-19 |
| Oral Surgery Contra (K211584) | Nakanishi, Inc. | 2021-08-19 |
| s-Clean Pre-Milled Abutment (K210362) | Dentis Co., Ltd. | 2021-08-19 |
| Servator P SALF Solution with THAM (K202652) | S.A.L.F. Spa | 2021-08-19 |
| SurgiLattice scaffold (K202425) | Tepha, Inc. | 2021-08-19 |
| mmRNA appliance (K210203) | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | 2021-08-19 |
| OsteoProbe (DEN210013) | Active Life Scientific, Inc. | 2021-08-19 |
| Empty EVA Bag (K210749) | Haemotronic S.P.A. | 2021-08-19 |