| Revitive Medic Plus, Revitive Advanced 2 (K190924) | Actegy , Ltd. | 2019-07-05 |
| Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask (K190254) | Sleepnet Corporation | 2019-07-05 |
| BTL 799-2L (K190456) | BTL Industries, Inc. | 2019-07-05 |
| Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) (K190950) | Medline Industries, Inc. | 2019-07-04 |
| Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim (K183149) | Central Medicare Sdn Bhd | 2019-07-04 |
| CMDR 2CW (Multiple models) (K191451) | Minxray, Inc. | 2019-07-03 |
| NuVasive® Camber Laminoplasty System (K191169) | Nu Vasive, Incorporated | 2019-07-03 |
| Novidia Flowable Composite (K182580) | Nobio , Ltd. | 2019-07-03 |
| Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors (K191018) | Surgical Instrument Service and Savings, Inc. | 2019-07-03 |
| XP Composite (K182780) | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | 2019-07-03 |
| Koios DS for Breast (K190442) | Koios Medical, Inc. | 2019-07-03 |
| OsteoFab Suture Anchors (K190915) | Oxford Performance Materials, Inc. | 2019-07-03 |
| Bluephase PowerCure (K190272) | Ivoclar Vivadent, AG | 2019-07-03 |
| syngo.CT Dual Energy (K191468) | Siemens Medical Solutions USA, Inc. | 2019-07-03 |
| Infinity Fixation System (K191204) | Conmed Corporation | 2019-07-03 |
| AlphaDent Implants Dental Implants System (K180968) | Alphadent Implants, Ltd. | 2019-07-03 |
| Arm-type Electronic Blood Pressure Monitor (K183058) | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019-07-03 |
| Biopsy Positioner (K191495) | Fujifilm Corporation | 2019-07-03 |
| Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments (K190589) | Cochlear Americas | 2019-07-03 |
| ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology (K190959) | Medtronic Sofamor Danek USA, Inc. | 2019-07-03 |
| MD-Temp Plus (K190724) | Meta Biomed Co., Ltd. | 2019-07-03 |
| Wrap accessory electrodes (K190617) | Hi-Dow International, Inc. | 2019-07-02 |
| Twilite Appliance (K190687) | Stephen J Harkins, Dds, PC | 2019-07-02 |
| iLab Polaris Multi-Modality Guidance System (K191008) | Boston Scientific Corporation | 2019-07-02 |
| Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System (K190634) | Cardiovascular Systems, Inc. | 2019-07-02 |
| Site Seal SV (K190351) | Ensite Vascular | 2019-07-02 |
| Uro-N Cystoscope (K182876) | Uroviu Corporation | 2019-07-02 |
| PWD Platform Wound Dressing 3” x 5” Oblong (K191460) | Applied Tissue Technologies, LLC | 2019-07-02 |
| Certain BellaTek Express and BellaTek Flex Abutments (K183138) | Biomet 3i | 2019-07-02 |
| 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (K191137) | Jvckenwood Corporation | 2019-07-02 |
| Hudson RCI Voldyne Volumetric Exerciser (K182847) | Teleflexmedical, Inc. | 2019-07-01 |
| Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter (K190980) | Innovative Health, LLC | 2019-07-01 |
| ASAHI Silverway (K183062) | Asahi Intecc Co., Ltd. | 2019-07-01 |
| IKON 40 Manual Wheelchair (K190550) | Broda Seating (Broda Lp) | 2019-07-01 |
| BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) (K190905) | Becton, Dickinson and Company | 2019-07-01 |
| MRopen 0.5 T (K190524) | Asg Superconductors S.P.A. | 2019-07-01 |
| TriMed Nitinol Staple System (K190166) | TriMed, Inc. | 2019-07-01 |
| LIGHTMED Ultrasound System (K183173) | Lightmed USA, Inc. | 2019-07-01 |
| Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System (K191450) | Dexcom, Inc. | 2019-06-28 |
| TxTi IBF System (K183064) | Innovasis, Inc. | 2019-06-28 |
| ClearEndoclip (K183021) | Finemedix Co., Ltd. | 2019-06-28 |
| RecoveryRx (K190251) | Bioelectronics Corporation | 2019-06-28 |
| iC-GN iC-Cassette for use on the iC-System (K190341) | Icubate, Inc. | 2019-06-28 |
| Stryker Surgeon iD Mandible Recon Plate (K190696) | Stryker | 2019-06-28 |
| NAVIO (K191223) | Blue Belt Technologies, Inc. | 2019-06-28 |
| Straumann CI RD Ceramic Healing Caps (K190654) | Institut Straumann AG | 2019-06-28 |
| Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (K190475) | Centerpoint Systems | 2019-06-28 |
| UltraFlex IAB (K190101) | Arrow International, Inc. | 2019-06-28 |
| MicroLink All-Suture Button Fixation System (Radiopaque) (K190582) | Conmed Corporation | 2019-06-28 |
| MicroLink All-Suture Button Fixation System (Radiolucent) (K190516) | Conmed Corporation | 2019-06-28 |
| SureTouch Mobile Pressure Mapping System (K181672) | Sure, Inc. | 2019-06-28 |
| HEALIX ADVANCE Anchor with DYNA+TAPE Sutures (K191483) | Medos International SARL | 2019-06-28 |
| Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove (K183389) | Hartalega NGC Sdn. Bhd. | 2019-06-28 |
| FlexGard Cut-Resistant Glove Liners (K190782) | Ldi Corporation | 2019-06-27 |
| ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (K191175) | Acist Medical Systems, Inc. | 2019-06-27 |
| Z-Robot Patient Positioning System (K182683) | Chinan Biomedical Technology, Inc. | 2019-06-27 |
| SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence (K190578) | Siemens Medical Solutions USA, Inc. | 2019-06-27 |
| Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) (K190080) | Comfort Rubber Gloves Industries Sdn. Bhd. | 2019-06-27 |
| LiverMultiScan (LMSv3) (K190017) | Perspectum Diagnostics, Ltd. | 2019-06-27 |
| VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture (K183183) | ETHICON, Inc. | 2019-06-27 |
| Rochal Bioshield Silicone Film (K182733) | Rochal Industries, LLC | 2019-06-27 |
| DynaFlex (K190583) | Dyna Flex | 2019-06-27 |
| Human IgM Kit for use on SPAPlus (K191465) | The Binding Site Group , Ltd. | 2019-06-27 |
| SwimCount Sperm Quality Test (K183602) | Motilitycount Aps | 2019-06-27 |
| ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector (K191438) | Erbe USA, Inc. | 2019-06-27 |
| Vantage Titan 3T, MRT-3010, V2.5 (K191128) | Canon Medical Systems Corporation | 2019-06-26 |
| Elos Accurate® Customized Abutment (K190299) | Elos Medtech Pinol A/S | 2019-06-26 |
| Deflectable Brush Biopsy Set (K191485) | Cook Incorporated | 2019-06-26 |
| SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (K182851) | O&M Halyard, Inc. | 2019-06-26 |
| Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set (K182832) | Cook Incorporated | 2019-06-26 |
| DigniCap Delta (K191166) | Dignitana, Inc. | 2019-06-26 |
| Phototherapy System (K190938) | Shanghai Apolo Medical Technology Co., Ltd. | 2019-06-26 |
| R2GATE (K190096) | Megagen Implant Co., Ltd. | 2019-06-26 |
| Straumann CARES Screw-Retained Bridges and Bars (K190097) | Institut Straumann AG | 2019-06-26 |
| Reprocessed PentaRay Nav eco High-Density Mapping Catheter (K190785) | Innovative Health, LLC | 2019-06-25 |
| CLARUS (K191194) | Carl Zeiss Meditec, Inc. | 2019-06-25 |
| Radio Frequency Ablation System (K190052) | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019-06-25 |
| WishBone Guided Growth System (K182704) | Wishbone Medical | 2019-06-25 |
| BUHLMANN fCAL turbo (K190784) | Buhlmann Laboratories AG | 2019-06-25 |
| Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System (K191207) | Taiwan Aulisa Medical Devices Technologies, Inc. | 2019-06-25 |
| Venus Bliss (K190743) | Venus Concept USA, Inc. | 2019-06-25 |
| Trevo XP ProVue Retriever (K190779) | Stryker | 2019-06-25 |
| Cepheid Xpert SA Nasal Complete Control Panel (K191168) | Microbiologics, Inc. | 2019-06-25 |
| Maxxi Rip Sensor (K171304) | Neurovirtual USA, Inc. | 2019-06-24 |
| Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire ; Tracking Pad ; Guidewire Handle (K190106) | Centerline Biomedical, Inc. | 2019-06-24 |
| Scooter, Model: R-100 (K182411) | Yongkang Dingchang Industry & Trade Co., Ltd. | 2019-06-24 |
| FUJIFILM Double Balloon Endoscope EI580BT (K183032) | Fujifilm Corporation | 2019-06-24 |
| MMSphere (K190443) | Galactic Beauty, LLC | 2019-06-24 |
| Oscillometric Blood Pressure Monitor (K190927) | Rudolf Riester GmbH | 2019-06-24 |
| uWS-CT (K183170) | Shanghai United Imaging Healthcare Co., Ltd. | 2019-06-24 |
| Orthoss(R) (K190754) | Geistlich Pharma AG | 2019-06-23 |
| ASAHI SASUKE (K182844) | Asahi Intecc Co., Ltd. | 2019-06-22 |
| The ClearSight finger cuffs (K190130) | Edwards Lifesciences, LLC | 2019-06-21 |
| AXTi Titanium Stand-Alone ALIF System (K182139) | Innovasis, Inc. | 2019-06-21 |
| JKH Stimulator Plus (K191151) | Jkh USA, LLC | 2019-06-21 |
| FloPatch (FP110) (K191388) | Flosonics Medical (R/A 1929803 Ontario Corp.) | 2019-06-21 |
| emFieldPro (K182963) | Zimmer Medizinsysteme GmbH | 2019-06-21 |
| MiiS Horus Scope DPT 100 (K181260) | Medimaging Integrated Solution, Inc (Miis) | 2019-06-21 |
| DePuy Synthes Plates and Screws Portfolio (K190750) | DePuy Synthes | 2019-06-21 |
| LineSider™ Spinal System (K190360) | Integrity Implants, Inc. | 2019-06-21 |