| Flyte (K212655) | Pelvital USA, Inc. | 2021-09-21 |
| T2 (K212303) | Osstem Implant Co., Ltd. | 2021-09-21 |
| Paige Prostate (DEN200080) | Paige.Ai | 2021-09-21 |
| Mariner Pedicle Screw System (K212692) | SeaSpine Orthopedics Corporation | 2021-09-21 |
| Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin (K200898) | Medicon Hellas S.A | 2021-09-21 |
| Elecsys Troponin T Gen 5 (K201441) | Roche Diagnostics | 2021-09-21 |
| KEYSTONE PEEK Cage System (K211689) | Shanghai Sanyou Medical Co, Ltd. | 2021-09-21 |
| IPL Home Use Hair Removal Device (K211922) | Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. | 2021-09-20 |
| Kubtec Mozart Supra (XPERT 84) Radiography System (K210955) | Kub Technologies, Inc. | 2021-09-20 |
| Latex Examination Powder Free Gloves (K211477) | Aspen Glove Sdn. Bhd. | 2021-09-20 |
| Medline Digital Thermometer Non-Lubricated Probe Sheath (K211931) | Medline Industries, Inc. | 2021-09-20 |
| ProFlex CO2 Laser Fiber (K203799) | Innovaquartz, LLC | 2021-09-20 |
| CT-STOR (K201789) | Energy Delivery Solutions | 2021-09-20 |
| SMILERS (K212961) | Biotech Dental Smilers, Sas | 2021-09-20 |
| Disposable Sampler Inactivated Transport Media, Nest ITM (K210440) | Wuxi Nest Biotechnology Co., Ltd. | 2021-09-20 |
| TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform (K212224) | Imperative Care, Inc. | 2021-09-20 |
| BreatheSuite MDI V1 (K203155) | Breathesuite, Inc. | 2021-09-17 |
| Syntec Orthodontic Mini Screw Extended System (K202790) | Syntec Scientific Corporation | 2021-09-17 |
| Intelligent NR (K212269) | Canon, Inc. | 2021-09-17 |
| Unifine SafeControl (K210399) | Owen Mumford, Ltd. | 2021-09-17 |
| Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 (K201832) | Olympus Medical Systems Corp. | 2021-09-17 |
| Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) (K203418) | Ningbo Ouhan Medical Device Co., Ltd. | 2021-09-17 |
| Deep Learning Image Reconstruction (K212067) | Ge Healthcare Japan Corporation | 2021-09-17 |
| WELLTRUST WT-III Mask with Flat Earloop (K211751) | Lonestar Meadows, LLC | 2021-09-17 |
| Incontinence Probe (K210441) | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2021-09-17 |
| Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector (K203762) | Covidien | 2021-09-17 |
| Vinyl Glove (K211904) | Jiangsu Dihong Industry and Trade Co., Ltd. | 2021-09-17 |
| Uramix CuraWay Biopsy Needle (K203141) | Uramix, Inc. | 2021-09-17 |
| Philips IntelliSite Pathology Solution (K203845) | Philips Medical Systems Nederland B.V. | 2021-09-17 |
| Tempo Natural Tampon (K212272) | Dong-A Pharmaceutical Co., Ltd. | 2021-09-17 |
| RedEx (K211234) | Advanced Surgical Concepts, Ltd. | 2021-09-17 |
| NTI ClenchGuard (K211158) | Boyd Research, Inc. | 2021-09-17 |
| Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System (K203111) | Medtronic | 2021-09-16 |
| Blue Nitrile Examination Glove Powder Free (K211479) | Aspen Glove Sdn. Bhd. | 2021-09-16 |
| StrataMR II Valves and Shunts (K212641) | Medtronic Neurosurgery | 2021-09-16 |
| GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating (K212742) | Waldemar Link GmbH & Co. KG | 2021-09-16 |
| Sterile Latex Surgical Gloves Powder Free (K211478) | Aspen Glove Sdn. Bhd. | 2021-09-16 |
| VISIONAIRE UK Patient Matched Cutting Guides (K211512) | Smith & Nephew, Inc. | 2021-09-16 |
| Symbia VA10A Family (K212604) | Siemens Medical Solutions USA, Inc. | 2021-09-16 |
| 6430 MyLabX75, 6430 MyLab XPro75 (K212021) | Esaote, S.p.A. | 2021-09-16 |
| BioRoot Flow 0.5g, BioRoot Flow 2g (K212283) | Septodont | 2021-09-16 |
| Disposable Medical Mask (K203112) | Yangzhou Runyi Arts & Crafts Co., Ltd. | 2021-09-16 |
| GlucoSure HT Plus Blood Glucose Monitoring System (K202885) | Apex BioTechnology Corp. | 2021-09-15 |
| HealthCCSng (K210085) | Zebra Medical Vision, Ltd. | 2021-09-15 |
| TruAbutment DS, TruBase (K203649) | Truabutment, Inc. | 2021-09-15 |
| GLOBAL UNITE™ Platform Shoulder System (K212710) | Depuy Ireland UC | 2021-09-15 |
| mi-eye 3 needlescope with cannula, mi-tablet 3 (K212556) | Trice Medical, Inc. | 2021-09-15 |
| HTx Disposable Hysteroscope System (K211227) | Acuvu, Inc. | 2021-09-15 |
| INFRARED BODY THERMOMETER (Model: YK-001) (K210118) | Longnan Renzhong Medical Equipment Co., Ltd. | 2021-09-15 |
| TrueCare Biomedix Tamper Evident Cap (K210818) | Us Infusion Inc. D/B/A Truecare Biomedix-USA | 2021-09-15 |
| BeamSite (K212606) | Doseoptics, LLC | 2021-09-15 |
| Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters (K211276) | Innovative Health, LLC | 2021-09-15 |
| Disposable Nitrile Gloves (K212009) | Jiangsu Shenglijie Safety Products Co., Ltd. | 2021-09-15 |
| RXS 1000 (K202369) | Rolence Enterprise, Inc. | 2021-09-15 |
| Instrument tray, for semi-rigid ureteroscope (K203492) | Olympus Winter & Ibe GmbH | 2021-09-15 |
| Rotarex Atherectomy System (K211738) | C.R. Bard, Inc. | 2021-09-14 |
| Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system (K210586) | Cardiovascular Systems, Inc. | 2021-09-14 |
| Compressible Limb and Circulation Therapy System, Model POWER-Q2300 (K211283) | Wonjin Mulsan Co., Ltd. | 2021-09-14 |
| Kleiner KG2 System (K211474) | BAAT Medical Products B.V. | 2021-09-14 |
| Viveve System, Viveve 2.0 System (K212678) | Viveve Medical, Inc. | 2021-09-14 |
| End Cap (K210461) | Medical Components Inc (Medcomp) | 2021-09-14 |
| Polaris X Unidirectional Steerable Diagnostic Catheter (K211494) | Boston Scientific Corporation | 2021-09-14 |
| Nitta M&T Safety Box (K211464) | Nitta M&T (Thailand) Co., Ltd. | 2021-09-14 |
| Wilson Tech Disposable Medical Face Mask (K210184) | Wilson Tech (International) Limited | 2021-09-14 |
| LIAISON Ferritin (K193650) | DiaSorin, Inc. | 2021-09-14 |
| PHOENIX (K212291) | Sedecal., Sa. | 2021-09-14 |
| ANNE One (K211305) | Sibel, Inc. | 2021-09-14 |
| Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation (K211389) | Magstim Company, Ltd. | 2021-09-14 |
| VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) (K202396) | bioMerieux, Inc. | 2021-09-14 |
| Harmony Referral System (K210396) | Topcon Healthcare Solutions EMEA Oy | 2021-09-13 |
| EliA Rib-P (K202540) | Phadia AB | 2021-09-13 |
| CIV-Clear cover (K211270) | CIVCO Medical Instruments Co., Inc. | 2021-09-13 |
| EDEN Peek Cage (K201793) | Jmt Co., Ltd. | 2021-09-13 |
| IRIS-XP (K212412) | Medicore Co., Ltd. | 2021-09-13 |
| EliA RNA Pol III (K202541) | Phadia AB | 2021-09-13 |
| HandX (K212214) | Human Xtensions , Ltd. | 2021-09-13 |
| Disposable Medical Mask (K203455) | Fujian Kang Chen Daily Necessities Co., Ltd. | 2021-09-13 |
| KONICAMINOLTA DI-X1 (K212685) | Konica Minolta, Inc. | 2021-09-13 |
| Surgical face mask (K211296) | Sunsmed Protective Products , Ltd. | 2021-09-11 |
| AlertWatch:AC (K210160) | Alertwatch, Inc. | 2021-09-10 |
| LOGIQ E10 (K211488) | GE Healthcare | 2021-09-10 |
| Versana Premier (K210438) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2021-09-10 |
| Aquilion Exceed LB (K211828) | Canon Medical Systems Corporation | 2021-09-10 |
| ClariSIGMAM (K203785) | Claripi, Inc. | 2021-09-10 |
| s-Clean Pre-Milled Abutment Mini (K210410) | Dentis Co., Ltd. | 2021-09-10 |
| gammaCore Sapphire (K211856) | Electrocore, Inc. | 2021-09-10 |
| Surgical Mask (K212451) | Remade USA, LLC | 2021-09-10 |
| Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K211375) | Boston Scientific Corporation | 2021-09-10 |
| EFAI PACS Picture Archiving and Communication System (K211257) | Ever Fortune.Ai, Co., Ltd. | 2021-09-10 |
| Iovera System (K211334) | Pacira Pharmaceuticals, Inc. | 2021-09-10 |
| JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve (K210625) | Fujifilm Medwork GmbH | 2021-09-10 |
| AccuFFRangio (K210093) | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
| Explorer TO System (K212540) | SeaSpine Orthopedics Corporation | 2021-09-10 |
| Kinepict Medical Imaging Tool 4.0 (K202056) | Kinepict Health, Ltd. | 2021-09-10 |
| Sterile syringe for single use with/without needle (K210227) | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-10 |
| Exofin Precision Pen (K212246) | Chemence Medical, Inc. | 2021-09-09 |
| cobas Cdiff nucleic acid test for use on the cobas Liat System (K210385) | Roche Molecular Systems, Inc. | 2021-09-09 |
| HERA W9, HERA W10 Diagnostic Ultrasound System (K211824) | Samsung Medison Co., Ltd. | 2021-09-09 |
| Electronic Thermometer (XHF2001, XHF2002) (K211352) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021-09-09 |
| DIGITAL RADIOGRAPHY CXDI-Pro, D1 (K212553) | Canon, Inc. | 2021-09-09 |