| PERFORM Humeral System – Stem (K201315) | Tornier, Inc. | 2020-09-11 |
| DePuy PINNACLE Dual Mobility Liner (K200854) | Depuy Ireland UC | 2020-09-11 |
| Fitbit ECG App (K200948) | Fitbit, Inc. | 2020-09-11 |
| DIAMOND-5A/6A/8A (K202156) | DRGEM Corporation | 2020-09-10 |
| HS Fiber (K202242) | Riverpoint Medical, LLC | 2020-09-10 |
| Navigation Module of the Momentum System (K200845) | Ulrich Medical USA | 2020-09-10 |
| SubNovii Advanced Plasma Technology (K201738) | Cartessa Aesthetics | 2020-09-10 |
| Diode Laser Body Sculpture System (K201731) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 |
| RGK Daily Range Wheelchairs (K200135) | Rgk Wheelchairs, Ltd. | 2020-09-10 |
| Straight T Clear Dental Aligner (K201450) | Straight T, Inc. | 2020-09-10 |
| CD Horizon™ Spinal System (K201407) | Medtronic Sofamor Danek USA, Inc. | 2020-09-10 |
| Disposable Vinyl Glove (K202008) | Best Care Trading Co., Ltd. | 2020-09-10 |
| DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (K201944) | Synthes (USA) Products, LLC | 2020-09-10 |
| X-Pac Expandable Lumbar Cage System (K201145) | Expanding Innovations, Inc. | 2020-09-10 |
| Tigereye CTO-Crossing Catheter (K201330) | Avinger, Inc. | 2020-09-10 |
| DSM Biomedical Dental Bone Graft Plus (K193212) | Dsm Biomedical | 2020-09-10 |
| RxSight Contact Lens (K201909) | Rxsight, Inc. | 2020-09-10 |
| DePuy Synthes Variable Angle Locking Patella Plating System (K201578) | Synthes (USA) Products, LLC | 2020-09-09 |
| MINT Product Family (K192423) | Hans Biomed Corporation | 2020-09-09 |
| Benesta Hysteroscope (K192822) | Caldera Medical, Inc. | 2020-09-09 |
| Perseus (K192653) | Orthokey Italia S.R.L. | 2020-09-09 |
| KetoSens BT Blood B-Ketone Monitoring System (K201551) | I-Sens, Inc. | 2020-09-09 |
| AcroDTI Visualizer (K201948) | Acroviz, Inc. | 2020-09-09 |
| Responsive Arthroscopy Suture Anchor System (K202153) | Responsive Arthroscopy, LLC | 2020-09-09 |
| Structur CAD (K201090) | Voco GmbH | 2020-09-09 |
| Keeogo Dermoskeleton System (K201539) | B-Temia, Inc. | 2020-09-09 |
| Vivid iq (K200708) | Ge Medical Systems Ultrasound And | 2020-09-09 |
| 3Shape Implant Studio (K202256) | 3Shape Medical A/S | 2020-09-09 |
| ClotTriever Thrombectomy System (K193462) | Inari Medical | 2020-09-09 |
| Vivid T8, Vivid T9 (K200851) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020-09-09 |
| CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV (K192730) | Biosystems S.A. | 2020-09-09 |
| SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) (K201829) | Medline Industries, Inc. | 2020-09-09 |
| Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027) | Jiangsu Caina Medical Co.,Ltd | 2020-09-09 |
| Vista Rinse, Vista Rinse Plus (K193409) | Inter-Med/Vista Dental Products | 2020-09-09 |
| Spectralis HRA+OCT and variants (K201252) | Heidelberg Engineering GmbH | 2020-09-09 |
| SubQKath Catheter and Needle Set (K193664) | Hk Surgical | 2020-09-09 |
| Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194) | Acuity Polymers, Inc. | 2020-09-08 |
| ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), (K202252) | Asahi Intecc Co., Ltd. | 2020-09-08 |
| Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit (K202014) | Siemens Medical Solutions USA, Inc. | 2020-09-08 |
| Surgical Mask-Model Number CW01 (K202354) | Hunan Heng Chang Pharmaceutical Co., Ltd. | 2020-09-08 |
| Disposable Medical Face Mask (K201470) | Jkh USA, LLC | 2020-09-08 |
| CD Horizon Spinal System (K202328) | Medtronic Sofamor Danek USA, Inc. | 2020-09-08 |
| EyeBOX (K201841) | Oculogica, Inc. | 2020-09-06 |
| Protective Face Mask for Medical Use (K201537) | Shandong Shengquan New Material Co., Ltd. | 2020-09-04 |
| Arthrex NanoScope System (K201134) | Arthrex, Inc. | 2020-09-04 |
| MSLS6QF TENS/PMS Device (K193655) | Self Doctor Care, LLC | 2020-09-04 |
| Lumipulse G CA15-3 (K192524) | Fujirebio Diagnostics,Inc. | 2020-09-04 |
| BD Syringe NRFit Lok and BD Syringe NRFit Slip (K192538) | Becton, Dickinson and Company | 2020-09-04 |
| NICU V'02 (K190561) | Cosmed Nordic Aps | 2020-09-04 |
| SIGNA Artist (K202238) | Ge Healthcare (Tianjin) Company Limited | 2020-09-04 |
| MEBO Wound Dressing (K193439) | Mebo Life Science, Inc. | 2020-09-04 |
| TruLift Expandable Spacer System (K201721) | Life Spine, Inc. | 2020-09-04 |
| Astopad Patient Warming System (K202197) | Stihler Electronic GmbH | 2020-09-04 |
| 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad (K200835) | 3M Company | 2020-09-04 |
| iCTmotor (WL-1) (K193341) | Dentium Co., Ltd. | 2020-09-04 |
| Neodent Implant System - GM Helix Implants 7.0 (K201225) | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2020-09-04 |
| Plain Surgical Mask (K201517) | Aok Tooling Limited | 2020-09-04 |
| Ambra ProViewer (K202335) | Dicom Grid Inc Dba Ambra Health | 2020-09-04 |
| BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair (K193599) | 21st Century Scientific, Inc. | 2020-09-03 |
| ArtPIX DRF (K202235) | Cmt Medical Technologies, Ltd. | 2020-09-03 |
| DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm (K201336) | Synthes (USA) Products, LLC | 2020-09-03 |
| Diamond Digital Sleep Orthotic (DDSO) (K202499) | Diamond Orthotic Laboratory | 2020-09-03 |
| Flat Panel Detector (K201591) | Ka Imaging, Inc. | 2020-09-03 |
| 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+ (K201211) | Shenzhen Beacon Display Technology Co., Ltd. | 2020-09-03 |
| Lyograft (K192452) | B. Bruan Surgical, SA | 2020-09-03 |
| Arthrex Syndesmosis TightRope XP Buttress Plate Implant System (K201522) | Arthrex, Inc. | 2020-09-03 |
| Delta III Lithotripter (K201074) | Dornier Medtech America, Inc. | 2020-09-03 |
| Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled (K200212) | Innovative Health, LLC | 2020-09-03 |
| Cavetto [MAX] Cervical Cage System (K201769) | Neurostructures, Inc. | 2020-09-03 |
| Cliq Aspirator (K201203) | Anest Iwata Sparmax Co., Ltd. | 2020-09-03 |
| Biodegradable Nitrile Examination Powder Free Glove, Green (K192111) | Top Glove Sdn. Bhd. | 2020-09-03 |
| 3D GraftRasp System (K201900) | Surgentec | 2020-09-03 |
| HaloGUARD Protective Disc with CHG (K200641) | Attwill Medical Solutions | 2020-09-03 |
| Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (K202176) | Medical Components, Inc. (dba MedComp) | 2020-09-03 |
| 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array (K201966) | 7D Surgical, Inc. | 2020-09-03 |
| MIS Dental Implant System (K200102) | Dentsply Sirona | 2020-09-03 |
| Endofresh Digestive Endoscopy System (K192704) | Huizhou Xzing Technology Co., Ltd. | 2020-09-02 |
| ATL Anchors (K200503) | International Life Sciences | 2020-09-02 |
| ExactechGPS System (K193618) | Blue Ortho | 2020-09-02 |
| LOCATOR R-Tx (K200827) | Ivory Super Holdco, Incp. | 2020-09-02 |
| Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 (K202169) | Qura S.R.L | 2020-09-02 |
| EtchPro Etching Gel (K200462) | Belport Company, Inc., Gingi-Pak | 2020-09-02 |
| Bright Temporary C&B (K192830) | Dmp Dental Industry S.A. | 2020-09-02 |
| VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter (K200812) | Philips Image Guided Therapy Corporation | 2020-09-02 |
| ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K202182) | Imperative Care, Inc. | 2020-09-02 |
| cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (K202215) | Roche Molecular Systems, Inc. | 2020-09-02 |
| Aesculap PAS-Port Proximal Anastomosis System (K202124) | Aesculap, Inc. | 2020-09-02 |
| ApolloVue S100 Image System (K201552) | Apollo Medical Optics, Ltd. | 2020-09-02 |
| Oral-B Dry Mouth Oral Rinse (K201277) | The Procter & Gamble Company | 2020-09-02 |
| Simplant Digital Guide (K193405) | Dentsply Sirona | 2020-09-02 |
| SmartHDM-510 System (K201765) | Mesa Laboratories, Inc. | 2020-09-02 |
| RX-1 Rhythm Express Remote Cardiac Monitoring System (K200833) | VivaQuant, Inc. | 2020-09-02 |
| OCT-Camera ID 21101A3 (K200516) | Optomedical Technologies GmbH | 2020-09-02 |
| EPIQ Series Diagnostic Ultrasound Systems (K202216) | Philips Ultrasound, Inc. | 2020-09-02 |
| Arthrex Mesh Plates (K201677) | Arthrex, Inc. | 2020-09-02 |
| Patient Administration Set (K200916) | Cyclomedica Australia Pty, Ltd. | 2020-09-01 |
| CAPOGEN Laser Cap (K201854) | Nature, Inc.redible, Inc. | 2020-09-01 |
| Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System (K202160) | FUJIFILM Sonosite, Inc. | 2020-09-01 |
| Endoscope Reprocessor OER-Elite (K201920) | Olympus Medical Systems Corp. | 2020-09-01 |
| Image1 S CCU, Image1 S 4U Camera Head (K201135) | KARL STORZ Endoscopy-America, Inc. | 2020-09-01 |