| Diode Laser Therapy Systems (K210168) | Beijing Kes Biology Technology Co., Ltd. | 2021-05-10 |
| Endo Motor (K203320) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-05-10 |
| Solax Electric Scooter (Models: S204311M, S204161, S204143) (K190737) | Dongguan Prestige Sporting Goods Co., Ltd. | 2021-05-10 |
| Bigfoot Unity Diabetes Management System (K202145) | Bigfoot Biomedical, Inc. | 2021-05-07 |
| Blue Nitrile Powder Free Patient Examination Glove, Non Sterile (K210366) | Onetexx Sdn Bhd | 2021-05-07 |
| SURGICAL MASK, Model Name:C015 (K210218) | Qingdao Hainuo Biological Engineering Co., Ltd. | 2021-05-07 |
| Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) (K210755) | Meditech Gloves Sdn Bhd | 2021-05-07 |
| Karl Storz Radel Sterilization Trays (K203572) | Karl Storz Endoscopy America, Inc. | 2021-05-07 |
| Reprocessed Tri Pulse Compression Garment (K203847) | Renu Medical, Inc. | 2021-05-07 |
| Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) (K203036) | Central Medicare Sdn Bhd | 2021-05-07 |
| FuseForce™ Flex Dynamic Compression System (K203832) | Wright Medical | 2021-05-07 |
| Corvus Radiation Therapy Planning System (K211034) | Best Nomos | 2021-05-06 |
| KardiFlex NC Coronary Dilatation Catheter (K202578) | Medcaptain Life Science Co., Ltd. | 2021-05-06 |
| CONDUIT Instruments (K210728) | Medos International SARL | 2021-05-06 |
| Talent-Pro Electromagnetic Stimulator (K202031) | Remed Co., Ltd. | 2021-05-06 |
| Umbilical Vessels Catheter (K201697) | Haolang Medical USA Corporation | 2021-05-06 |
| SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL (K201936) | Gilero, LLC | 2021-05-06 |
| Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 (K210705) | Defender Safety, Inc. | 2021-05-06 |
| 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 (K202598) | 3A Medical Products Co., Ltd. | 2021-05-06 |
| AutoCap RX (K210353) | Boston Scientific Corporation | 2021-05-06 |
| CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) (K203183) | Bolder Surgical, LLC | 2021-05-06 |
| Identity Imprint Knee Replacement System (K210191) | Conformis, Inc. | 2021-05-06 |
| ImagePilot (K210066) | Konica Minolta, Inc. | 2021-05-06 |
| DRPx Locking Distal Radius Plate System (K202971) | Orthopaedic Implant Company | 2021-05-06 |
| Dr. Yglo Wart Remover (K210529) | Theotclab Healthcare B.V. | 2021-05-06 |
| CoolSeal Reveal (K203640) | Bolder Surgical, LLC | 2021-05-06 |
| D function (K203525) | Ito Co., Ltd. | 2021-05-05 |
| OrthoGold 100 (K210451) | Tissue Regeneration Technologies, LLC | 2021-05-05 |
| OIC External Fixation System (K211112) | Orthopaedic Implant Company | 2021-05-05 |
| GR-14 Resin System (K210298) | Pro3Dure Medical GmbH | 2021-05-05 |
| Genius / Genuin Total Knee System (K200765) | Biorad Medisys Pvt, Ltd. | 2021-05-05 |
| Bose SoundControl Hearing Aids (K211008) | Bose Corporation | 2021-05-05 |
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) (K203450) | Capnostics, LLC | 2021-05-04 |
| ProntoPump Sterile Tube Set (K200893) | Ipax, Inc. | 2021-05-04 |
| Uro-G Cystoscope (K202921) | Uroviu Corporation | 2021-05-04 |
| CaP Spheres Pellet Pack (K203218) | Zimmer Biomet Spine, Inc. | 2021-05-04 |
| NaviCam Xpress Stomach System (K203192) | Anx Robotica Corp | 2021-05-04 |
| A-Link Z (K201671) | Acuity Surgical Devices, LLC | 2021-05-04 |
| SOTA Cloud Imaging (K210682) | Sota Precision Optics, Inc. Dba Sota Imaging | 2021-05-04 |
| CoLink Sfx Implant System (K203698) | In2bones USA, LLC | 2021-05-04 |
| Rebellion, Phantom Multi-Bite Kerrison Rongeur (K200768) | Morpheus AG | 2021-05-04 |
| Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) (K203655) | Innovative Health, LLC | 2021-05-04 |
| Surgical Mask (K210304) | Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z. | 2021-05-04 |
| VASSALLO GT Hybrid (K203529) | Filmecc Co., Ltd. | 2021-05-04 |
| Electric Breast Pump (K201152) | Guangdong Horigen Mother & Baby Products Co., Ltd. | 2021-05-04 |
| PtoleMedic System (K202521) | Lento Medical Innovation, Inc. | 2021-05-04 |
| Medline Vacu-line Suction Aspirator (K203135) | Medline Industries, Inc. | 2021-05-04 |
| Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable (K203749) | Ambu A/S | 2021-05-03 |
| EasyWhip (K210675) | Winter Innovations, Inc. | 2021-05-03 |
| MC3 Crescent Jugular Dual Lumen Catheter (K203409) | Mc3, Inc. | 2021-05-03 |
| Storz Medical MAGNETOLITH Muscle Stimulator (K203710) | Storz Medical AG | 2021-05-03 |
| Kerecis Reconstruct (K202430) | Kerecis Limited | 2021-05-02 |
| Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (K201949) | Nihon Kohden Corporation | 2021-05-02 |
| SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter (K210647) | Vascular Solutions, LLC | 2021-04-30 |
| ProLift Lateral HELO Fixated (K210061) | Life Spine, Inc. | 2021-04-30 |
| CereLink ICP Monitor (K210993) | Integra Lifesciences Production Corporation | 2021-04-30 |
| ArtiSential Laparoscopic Instruments-Electrodes (K203580) | Livsmed, Inc. | 2021-04-30 |
| syngo. CT Extended Functionalities (K203699) | Siemens Medical Solutions USA, Inc. | 2021-04-30 |
| Innova Nasal Non-Vented Mask (K203601) | Sleepnet Corporation | 2021-04-30 |
| The BioBrace Implant (K203267) | Biorez, Inc. | 2021-04-30 |
| Disposable Ureteral Access Sheath (K203165) | Suzhou Beyo Medical Technology Co., Ltd. | 2021-04-30 |
| JACE Medical Thoracic Plating System (K210290) | Jace Medical, LLC | 2021-04-30 |
| MAC 7 - Resting ECG Analysis System (K203786) | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 |
| FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 (K211013) | Inari Medical, Inc. | 2021-04-30 |
| HYPER AiR (K210001) | Shanghai United Imaging Healthcare Co., Ltd. | 2021-04-30 |
| OsteoCentric Integrated Hip Fastener System (K210247) | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021-04-30 |
| CD Horizon™ Spinal System (K210637) | Medtronic | 2021-04-30 |
| AcuityDRe (K210919) | Radmedix, LLC | 2021-04-30 |
| Expandable Titanium PLIF/TLIF System (K201024) | Spectrum Spine, LLC | 2021-04-29 |
| Pure Vu System (K210981) | Motus GI Medical Technologies , Ltd. | 2021-04-29 |
| M1 Surgical Face Mask (K202457) | CHISON Medical Technologies Co., Ltd. | 2021-04-29 |
| KardiFlex PTCA Balloon Dilatation Catheter (K202619) | Medcaptain Life Science Co., Ltd. | 2021-04-29 |
| Rescue Pulmonary Grasping Forceps (K202987) | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-29 |
| Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) (K210944) | Harbour Health, LLC | 2021-04-29 |
| 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation (K210605) | 3M Company | 2021-04-29 |
| Infrared Thermometer (K203454) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-04-29 |
| Disposable Nitrile Examination Gloves (K203436) | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2021-04-28 |
| 1717FCC (K210985) | Rayence Co., Ltd. | 2021-04-28 |
| Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber (K210925) | Boston Scientific | 2021-04-28 |
| Oral/Enteral Syringe (K210621) | Ningbo Tianyi Medical Appliance Co., Ltd. | 2021-04-28 |
| Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (K203277) | Olympus Winter & Ibe GmbH | 2021-04-28 |
| Astroglide X Silicone Personal Lubricant (K210242) | Biofilm, Inc. | 2021-04-28 |
| Titan SGS (K210278) | Standard Bariatrics | 2021-04-28 |
| Medical Mask (K210020) | Zhende Medical Co., Ltd. | 2021-04-28 |
| Trinias (K203535) | Shimadzu Corporation Medical Systems | 2021-04-28 |
| BI-MENTUM™ ALTRX® Dual Mobility Liner (K203532) | Depuy Ireland UC | 2021-04-28 |
| AMX Navigate (K210982) | Ge Medical Systems, LLC | 2021-04-28 |
| TCL3 Motion Tracking System (K203451) | Tracinnovations Aps | 2021-04-28 |
| Plato 17 Microcatheter (K210601) | Scientia Vascular, LLC | 2021-04-28 |
| MPACT Extension (K200391) | Medacta International S.A. | 2021-04-28 |
| CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor (K202757) | Contec Medical Systems Co.,Ltd | 2021-04-28 |
| AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens (K210609) | Vp Optics | 2021-04-27 |
| Responsive Arthroscopy Thunderbolt System (K203121) | Responsive Arthroscopy, LLC | 2021-04-27 |
| Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device (K191951) | Avazzia, Inc. | 2021-04-27 |
| Stone Retrieval Balloon Catheter (K210660) | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-27 |
| Safety Trocar Cannula (K211072) | Boston Scientific Corporation | 2021-04-27 |
| STARband, STARlight, St. Louis Band (K203098) | Orthomerica Products, Inc. | 2021-04-27 |
| AccelX Abutments (K203240) | Integrated Dental Systems, LLC | 2021-04-27 |
| Resonic Rapid Acoustic Pulse Device (K210964) | Soliton, Inc. | 2021-04-27 |