| electrocardiograph: SE-1202 (K210140) | Edan Instruments, Inc. | 2021-10-01 |
| iotaSOFT Insertion System - Drive Unit, Controller and Accessories (DEN190055) | Iotamotion, Inc. | 2021-10-01 |
| Jada System (K212757) | Alydia Health | 2021-09-30 |
| Intravascular Administration Sets (K203609) | Baxter Healthcare Corporation | 2021-09-30 |
| Small Bone Nailing System (K211439) | Skeletal Dynamics, Inc. | 2021-09-30 |
| ORIO-Ti Intervertebral Body Fusion Cage System (K211935) | Spinecraft, LLC | 2021-09-30 |
| Acuitas AMR Gene Panel (K191288) | Opgen, Inc. | 2021-09-30 |
| NAEOTOM Alpha, Scan&GO (K211591) | Siemens Medical Solutions USA, Inc. | 2021-09-30 |
| Enteral Pump Syringe (K211593) | Jiangsu Caina Medical Co.,Ltd | 2021-09-30 |
| Philips MR Patient Care Portal (K212227) | Invivo Corporation | 2021-09-30 |
| AngioVac F18 85 (K212386) | AngioDynamics, Inc. | 2021-09-30 |
| EMERGE™ Anterior Cervical Plate System (K212405) | Evolution Spine | 2021-09-30 |
| Accuray Precision Treatment Planning System (K212794) | Accuray Incorporated | 2021-09-30 |
| Implanova (K210523) | Dental Evolutions, Inc. | 2021-09-30 |
| SteriCap Mini Needle and Standard Needles (K212805) | Ocuject, LLC | 2021-09-30 |
| Philips IntelliVue GuardianSoftware (Rev. E.0X) (K212208) | Philips Medizin Systeme Boeblingen GmbH | 2021-09-30 |
| Playboy 3 Contour Condom (K211450) | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-30 |
| ENDOtube (K203350) | Nissha Medical Technologies Sas | 2021-09-29 |
| UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 (K210513) | Universal Incorporation | 2021-09-29 |
| DR Safety Syringe, Sterile Hypodermic needle for Single use (K212226) | Zhuhai DR Medical Instruments Co., Ltd. | 2021-09-29 |
| LAP-iX (K200639) | Sejong Medical Co., Ltd. | 2021-09-29 |
| ImmersiveTouch (K210726) | Immersivetouch, Inc. | 2021-09-29 |
| Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136) | Cochlear Americas | 2021-09-29 |
| Inman Digital Clear Aligners (K210763) | Inman Orthodontic Laboratories, Inc. | 2021-09-29 |
| Axis Spine Technologies ALIF (K210590) | Axis Spine Technologies, Ltd. | 2021-09-29 |
| DualX (K211740) | Amplify Surgical, Inc. | 2021-09-29 |
| TheraFace Microcurrent (K212238) | Theragun, Inc. | 2021-09-29 |
| RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles (K203668) | Myco Medical Supplies, Inc. | 2021-09-29 |
| Disposable Nitrile Gloves (K211781) | Jiangsu Jinke Protective Equipment Co., Ltd. | 2021-09-29 |
| Da Vinci SP Surgical System (K212747) | Intuitive Surgical, Inc. | 2021-09-29 |
| EzDent Web (K211700) | Ewoosoft Co., Ltd. | 2021-09-28 |
| SIDDHARTH-II; IMPACT (K210894) | Panacea Medical Technologies Pvt. , Ltd. | 2021-09-28 |
| Persona® Personalized Knee System (K212129) | Zimmer Switzerland Manufacturing GmbH | 2021-09-28 |
| Surgical Face Mask (Model: CM2006, CM2008, A88) (K210878) | Shenzhen Realtone Medical Appliance Co., Ltd. | 2021-09-28 |
| Electrically Powered Wheelchair -Model HP358E (K201855) | Kunshan Hi-Fortune Health Products Co., Ltd. | 2021-09-28 |
| SoftSpot (K212045) | Pediametrix, Inc. | 2021-09-28 |
| ThermArt (Model IR-EFT) (K202481) | Comper Chuangxiang (Beijing) Technology Co., Ltd. | 2021-09-28 |
| Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac (K212320) | 3M Healthcare Business Group | 2021-09-28 |
| Panther OIS (K211760) | Prowess, Inc. | 2021-09-28 |
| Disposable surgical mask (K211794) | Shanghai No.9 Knitting Mill Co., Ltd. | 2021-09-28 |
| Advisor Pro Platform (K210561) | DreaMed Diabetes, Ltd. | 2021-09-28 |
| SubtlePET (K211964) | Subtle Medical, Inc. | 2021-09-28 |
| POWERSEAL Curved Jaw Sealer and Divider, Double Action (K212643) | Olympus Surgical Technologies America | 2021-09-27 |
| Disposable Vinyl Examination Gloves (K211236) | Tangshan Hongyun Healthcare Products Co., Ltd. | 2021-09-27 |
| Dark Star Navigation Instrument System (K212028) | Republic Spine, LLC | 2021-09-27 |
| Amplatzer Talisman Delivery Sheath (K212738) | ABBOTT MEDICAL | 2021-09-27 |
| Ultrasonic Surgical Aspirator System, Model: XD880B (K212750) | Smtp Technology Co., Ltd. | 2021-09-27 |
| Amplatzer Steerable Delivery Sheath (K212026) | ABBOTT MEDICAL | 2021-09-27 |
| Imaging Plate Scanner, i-Scan (K212080) | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021-09-27 |
| B Dispensing Line (K203674) | Aea Srl | 2021-09-27 |
| Surgical Mask (K210908) | Sichuan Prius Biotechnology Co., Ltd. | 2021-09-26 |
| DiscCath Needle Set (K212328) | Disccath, LLC | 2021-09-26 |
| Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove (K201592) | Cardinal Health200, LLC | 2021-09-26 |
| Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter (K202459) | Pharma System AB | 2021-09-26 |
| DT100 Digital Thermometer (K203731) | Smart Technology Co., Ltd. | 2021-09-26 |
| Red Wave Hair Removal (K212099) | Shenzhen Accompany Technology Co., Ltd. | 2021-09-24 |
| Encore Hip Stem (K211505) | Signature Orthopaedics Pty, Ltd. | 2021-09-24 |
| Dynamic TiBase (K212108) | Talladium España, SL | 2021-09-24 |
| Collaboration Live (K212777) | Philips Ultrasound, Inc. | 2021-09-24 |
| DRI Cocaine Metabolite Assay (K211973) | Microgenics Corporation | 2021-09-24 |
| ViperCross Support Catheters (K212725) | Cardiovascular Systems, Inc. | 2021-09-24 |
| IV Administration Sets (K202618) | B.Braun Medical, Inc. | 2021-09-24 |
| Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (K212125) | Nobel Biocare AG | 2021-09-24 |
| Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System (K212704) | Philips Medical Systems | 2021-09-24 |
| Personal Lubricant (K210857) | Shenzhen Huanqiu Xuebao Technology Co., Ltd. | 2021-09-24 |
| Virtual C DRF-NEO Digital Imaging System (K212557) | Portavision Medical, LLC | 2021-09-24 |
| Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage (K212792) | Medynus, Inc. | 2021-09-23 |
| TorrentX Wound Wash (K203446) | Next Science, LLC | 2021-09-23 |
| Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (K211667) | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 |
| OnGuard2 Chemfort Closed Administration (CADM) (K210707) | Simplivia Healthcare , Ltd. | 2021-09-23 |
| Standard Bougie, 38 Fr. and Hand Pump (K212728) | Standard Bariatrics | 2021-09-23 |
| Synthetic Vinyl Examination Gloves (K212002) | Yunnan Huazhiyuan Medical Technology Co., Ltd. | 2021-09-23 |
| Reusable NIBP Cuff (K211747) | Shenzhen Coreray Technology Co., Ltd. | 2021-09-23 |
| ZIIP+ Device (K212342) | Ziip, Inc. | 2021-09-23 |
| Sterile Hypodermic Needles for Single Use (K210232) | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2021-09-23 |
| Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) (K211827) | Zhejiang Lanhine Medical Products, Ltd. | 2021-09-23 |
| Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 (K203662) | Yibin Junxin Electronics Technology Co., Ltd. | 2021-09-23 |
| ABC Dental Implant System (K202092) | Abracadabra Implants , Ltd. | 2021-09-23 |
| JiveX (Model Number / Release: 5.3) (K212321) | Visus Health IT GmbH | 2021-09-23 |
| Automatic Digital Blood Pressure Monitor (K210152) | Aviche Shandong Medical Technology Co, Ltd. | 2021-09-23 |
| LED PHOTIC System (K211974) | Micromed S.P.A. | 2021-09-23 |
| Halo One Thin-Walled Guiding Sheath (K212708) | C.R. Bard, Inc. | 2021-09-23 |
| Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) (K212411) | Conformis, Inc. | 2021-09-23 |
| One Touch Spiral Condom (K210294) | Thai Nippon Rubber Industry Public Company Limited. | 2021-09-23 |
| Nexta PEEK Hammertoe Correction System (K211996) | Nextremity Solutions, Inc. | 2021-09-23 |
| SimpleSENSE Platform (K212160) | Nanowear, Inc. | 2021-09-22 |
| DB-EZ Bone Void Filler (K212353) | Dimensional Bioceramics, LLC | 2021-09-22 |
| Electric Wheelchair (XW-LY001) (K200423) | Yongkang Dingchang Industry & Trade Co., Ltd. | 2021-09-22 |
| Banyan USA Surgical Mask Level 3 (K211097) | Banyan USA, LLC | 2021-09-22 |
| IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System (K211805) | Alphatec Spine, Inc. | 2021-09-22 |
| Smylio Invisible Clear Aligners (K212660) | Smylio, Inc. | 2021-09-22 |
| 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) (K210772) | Vr Vertical, LLC Dba Xrgo | 2021-09-22 |
| Single Use Guide Sheath Kit-401, K-402 (K212667) | Olympus Medical Systems Corp. | 2021-09-22 |
| ACTIVA PRESTO PACK (K210045) | Pulpdent Corporation | 2021-09-22 |
| FilmArray Pneumonia Panel (K212727) | Biofire Diagnostics, LLC | 2021-09-22 |
| Mpres Neck Preserving Stem (K210263) | Medacta International S.A. | 2021-09-22 |
| Disposable Nitrile Examination Gloves (K211073) | Foshan Kangkang Biotechnology Co., Ltd. | 2021-09-21 |
| Dayspring Lite (K212287) | Koya Medical, Inc. | 2021-09-21 |
| GEO Extremity and Ankle Plating System (K212334) | Gramercy Extremity Orthopedics, LLC | 2021-09-21 |
| ProxiDiagnost N90 (K212837) | Philips Medical Systems Dmc GmbH | 2021-09-21 |