| 1 Series Phototherapy Equipment (K220840) | Daavlin Distributing Co. | 2022-04-22 |
| Lorals (K212928) | Brazen Goods Inc. Dba Lorals | 2022-04-22 |
| MirrorMe3D Modeling System (K212981) | Mirrorme3D, LLC | 2022-04-22 |
| HealthOST (K213944) | Nanoxai , Ltd. | 2022-04-22 |
| ATUSA™ Automated 3D Breast Ultrasound System (K213620) | Isono Health, Inc. | 2022-04-22 |
| CoNextions TR Tendon Repair System (K203855) | Conextions Medical | 2022-04-22 |
| RibFix Blu Thoracic Fixation System (K212608) | Biomet Microfixation | 2022-04-22 |
| Waterlase iPLus (K210183) | Biolase, Inc. | 2022-04-21 |
| Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple (K220382) | Jiangsu Bytech Medical Supplies Co., Ltd. | 2022-04-21 |
| Venus Bulk Flow ONE (K220605) | Kulzer, LLC | 2022-04-21 |
| MESI mTABLET TBI diagnostic system, MESI mTABLET TBI (K213730) | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2022-04-21 |
| Tempo Tampon (K212277) | Dong-A Pharmaceutical Co., Ltd. | 2022-04-21 |
| Ivory Glove Powder-Free Nitrile Examination Gloves (K213681) | Ivory Gloves Sdn. Bhd. | 2022-04-21 |
| INHANCE™ Reverse Shoulder System (K212737) | Depuy Ireland UC | 2022-04-21 |
| Videa Caries Assist (K213795) | Videahealth, Inc. | 2022-04-21 |
| GEMS-H (K213452) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| GM85 (K220175) | Samsung Electronics Co., Ltd. | 2022-04-21 |
| HydroMARK Breast Biopsy Site Marker (K212158) | Devicor Medical Products, Inc. | 2022-04-21 |
| FEMTO LDV Z8 Femtosecond Surgical Laser (K213559) | Sie Ag,Surgical Instrument Engineering | 2022-04-21 |
| EKOS+ Endovascular Device (K220866) | Boston Scientific | 2022-04-20 |
| SmoothCool HR System (K213484) | Jeisys Medical, Inc. | 2022-04-20 |
| Auxo A300, A150 and APod (K220543) | Auxo Hair, LLC | 2022-04-20 |
| GEM FLOW COUPLER Monitor (GEM1020M-2) (K213974) | Synovis Micro Companies Alliance, Inc. | 2022-04-20 |
| 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (K212022) | 3M Company | 2022-04-20 |
| Saberscope5 Laparoscope (K220872) | Xenocor, Inc. | 2022-04-20 |
| QUATERA 700 (K212241) | Carl Zeiss Meditec, AG | 2022-04-19 |
| Infinity™ OCT System and PASS OCT Spinal System (K220810) | Medicrea International | 2022-04-19 |
| Spartan Center Wire (K220075) | Spartan Micro, Inc. | 2022-04-19 |
| Altus Spine Interbody Standalone Fusion System (K211837) | Altus Partners, LLC | 2022-04-19 |
| V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (K192931) | Helena Laboratories, Corp. | 2022-04-19 |
| Brainlab Elements Guide XT, Guide 3.0 (K213930) | Brainlab AG | 2022-04-19 |
| TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) (K220152) | Hong Qiangxing (Shenzhen) Electronics Limited | 2022-04-19 |
| General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) (K220149) | Xera Medical Systems & Technology , Ltd. | 2022-04-19 |
| KYPHON VuE Bone Cement (K220131) | Tecres S.P.A. | 2022-04-18 |
| Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair (K212952) | Psychemedics Corporation | 2022-04-18 |
| Nautilus (K220871) | Dornier Medtech America, Inc. | 2022-04-18 |
| BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free (K213408) | Meditech Gloves Sdn Bhd | 2022-04-17 |
| Lilliput APD System (K212522) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-04-15 |
| XD (K220779) | Mirada Medical, Ltd. | 2022-04-15 |
| FootHold System (K220797) | Crossroads Extremity Systems, LLC | 2022-04-15 |
| aboNT SYRINGE (K212677) | Nipro Medical Corporation | 2022-04-15 |
| mJOULE System and Accessories (K213350) | Sciton, Inc | 2022-04-15 |
| SURGIVISIO Device (K220946) | Ecential Robotics | 2022-04-15 |
| ARDO Alyssa (K212773) | Ardo Medical AG | 2022-04-15 |
| Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 (K212377) | Ningbo Medkinetic Medical Device Co., Ltd. | 2022-04-15 |
| AI-Rad Companion Brain MR (K213706) | Siemens Healthcare GmbH | 2022-04-15 |
| Mako Total Knee Application (K220459) | Mako Surgical Corp. | 2022-04-15 |
| RayStation 11B (K220141) | RaySearch Laboratories AB (PUBL) | 2022-04-15 |
| TeleScan (K220767) | Bb Imaging | 2022-04-14 |
| MagnetOs Flex Matrix (K213959) | Kuros Biosciences B.V | 2022-04-14 |
| VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) (K214023) | bioMerieux, Inc. | 2022-04-14 |
| Yushan X-Ray Flat Panel Detector with DROC (K220510) | Innocare Optoelectronics Corp. | 2022-04-14 |
| Disposable Medical Nitrile Examination Gloves (K220561) | Nanjing Universal Medical Equipment Co., Ltd. | 2022-04-14 |
| High Retention Attachment System (K220252) | Zest Anchors, LLC | 2022-04-14 |
| Coala Heart Monitor (K212163) | Coala Life AB | 2022-04-14 |
| Amputee Garment for use with Lympha Press Optimal Plus (K214053) | Mego Afek AC , Ltd. | 2022-04-14 |
| WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System (K212202) | OTU Medical, Inc. | 2022-04-13 |
| OpenSensorX Series (K220556) | Dentimax, Inc. | 2022-04-13 |
| CARESCAPE B450, E-musb (K213363) | GE Healthcare Finland Oy | 2022-04-13 |
| ZENEX Implant System (K211090) | Izenimplant Co., Ltd. | 2022-04-13 |
| MCL 31 Dermablate System (K210634) | Asclepion Laser Technologies GmbH | 2022-04-13 |
| Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220373) | Summit Glove, Inc. | 2022-04-13 |
| Neodent Implant System-Helix NGM Compact Surgical Kit Cases (K214051) | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2022-04-13 |
| Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) (K220375) | Summit Glove, Inc. | 2022-04-13 |
| Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning (K212245) | Brainlab AG | 2022-04-13 |
| Keffort (MC-100, MC-100A) (K213133) | Oriental Inspiration Limited | 2022-04-13 |
| Carescape B850, E-musb (K213336) | GE Healthcare Finland Oy | 2022-04-13 |
| Bendit21 Microcatheter (K203842) | Bend IT Technologies, Ltd. | 2022-04-13 |
| CARESCAPE B650, E-musb (K213181) | GE Healthcare Finland Oy | 2022-04-13 |
| BIOTEQ Drainage Catheter BT-PDS-series (K210419) | Bioteque Corporation | 2022-04-13 |
| Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) (K210148) | Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. | 2022-04-13 |
| Cannulated Compression Device System (K210146) | Orthopedic Designs North America, Inc. | 2022-04-13 |
| Sensuva Premium Silicone Personal Lubricant (K212260) | Valencia Naturals, Inc. | 2022-04-13 |
| Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) (K220773) | Medtronic Vascular | 2022-04-13 |
| Disposable Surgical Gown (K214088) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2022-04-12 |
| EMBOLD Fibered Detachable Coil System (K213398) | Boston Scientific Corporation | 2022-04-12 |
| LED Therapy Device (Planar LED/Planar LED mini) (K220103) | Shenzhen Leaflife Technology Co., Ltd. | 2022-04-12 |
| Anprolene SteriTest RRBI (K213296) | Andersen Sterilizers, Inc. | 2022-04-12 |
| Anteralign Spinal System with Titan nanoLOCK Surface Technology (K214010) | Medtronic Sofamor Danek USA | 2022-04-12 |
| CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 (K213234) | Ge Medical Systems Information Technologies, Inc. | 2022-04-12 |
| Ti3Z Lumbar Interbody System (K212811) | Zavation Medical Products, LLC | 2022-04-12 |
| Audion ET dilation system (K220027) | Entellus Medical, Inc. | 2022-04-12 |
| Amis K Long (K220405) | Medacta International S.A. | 2022-04-12 |
| ThermPix Thermovisual Camera (K213650) | Usa Therm, Inc. | 2022-04-12 |
| ClearPoint Array System (version 1.1) (K214040) | ClearPoint Neuro, Inc. | 2022-04-12 |
| PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter (K214025) | Medos International SARL | 2022-04-12 |
| Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) (K214075) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-04-12 |
| Finexel (K213557) | SNJ Co., Ltd. | 2022-04-12 |
| CARESCAPE CO2 Microstream parameter (K213518) | Covidien, LLC | 2022-04-12 |
| Intense Pulsed Light (IPL) System (K212881) | Shenzhen Fansizhe Science and Technology Co., Ltd. | 2022-04-11 |
| XO CROSS CORONARY Support Catheter (K214107) | Transit Scientific, LLC | 2022-04-11 |
| G-EYE System (K220158) | Smart Medical Systems , Ltd. | 2022-04-11 |
| TRELLIS™ SI Joint Fusion System (K212962) | Orthofundamentals, LLC | 2022-04-11 |
| Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims (K213437) | Central Medicare Sdn Bhd | 2022-04-11 |
| Powder Free Nitrile Examination Glove, Non-sterile (Blue) (K220209) | Ksg Medicare Sdn. Bhd. | 2022-04-11 |
| Micro Catheter and Guidewire System (K212719) | Suzhou Hengrui Hongyuan Medical Co., Ltd. | 2022-04-11 |
| Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black (K220121) | Aamedix Glove Sdn Bhd | 2022-04-11 |
| World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) (K220737) | Signature Orthopaedics Pty, Ltd. | 2022-04-11 |
| Cellvizio 100 series system with confocal Miniprobes (K220477) | Mauna Kea Technologies | 2022-04-11 |
| MP Reconstruction System (K213675) | Waldemar Link GmbH & Co. KG | 2022-04-11 |