FDA 510(k) clearances — page 277
clearances on record, most recent first.
Clearances — page 277
27,601–27,700 of 175,699- K170498 — Gems Oocyte Retrieval Buffer ORB-20, ORB-50
- K170802 — TRAUMACEM V+ Injectable Bone Cement
- K171212 — AirFit N20
- K171633 — NuVasive TLX Interbody System
- K171728 — MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm
- K171894 — NuVasive® Precept Spinal System
- K171922 — Anatotemp Anatomic Dental Implant Healing Abutment
- K171965 — Resection Electrodes with HF cable
- K172595 — CUSA Excel+ Ultrasonic Surgical Aspirator System
- K172612 — FiberTak DX
- K172659 — MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST - Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture
- K170183 — Cetus system, Cetus probe
- K170482 — Spider Frame External Fixation System
- K170810 — CRYOFOS
- K171211 — OIC External Fixation System
- K171215 — QiF Blood and Fluid Warmer
- K171661 — Scopis Extended Instrument Set EM
- K171936 — Peerbridge Cor(TM) System
- K171941 — FreeStyle Precision Neo Blood Glucose Test Strips
- K172109 — Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL
- K172275 — Vitality® Spinal Fixation System, Vitality®+ Power Instrument System
- K170162 — Vesco Medical Nasoenteric Feeding Tubes
- K170816 — Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
- K171107 — CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
- K171963 — Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
- K171992 — SculpSure
- K172015 — POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED)
- K172101 — ROMEO® 2 Posterior Osteosynthesis System
- K172581 — CareView 1800Cw X-ray Flat Panel Detectors
- K163270 — ISEN-Goggles with Data Viewer
- K163577 — Ecofit® Hip System
- K170157 — INDEPENDENCE® Spacers
- K170985 — Urbanek Device
- K171161 — Dimensional Bioceramics Calcium Sulfate Device (DB-CSD)
- K171442 — Exofin Fusion Skin Closure System
- K171726 — LapBag
- K171862 — GALAXY G3 Mini Microcoil Delivery System
- K171943 — Electrocardiograph
- K172126 — Xpert Xpress Strep A
- K172628 — PRECICE System
- K171460 — Powder-free Clear Vinyl Patient Examination Gloves
- K162848 — Straumann CARES Golden Ti/TiN Abutments
- K162956 — NOWCARDIO SYSTEM
- K163674 — Exsens Personal Lubricant - Pure Aqua, Exsens Personal Lubricant - Aloe Vera, Exsens Personal Lubricant - Fresh Mint, Exsens Personal Lubricant - Candy Apple, Exsens Personal Lubricant - Raspberry
- K170758 — Thermage FLX System and Accessories
- K170956 — SYSTEM 1E Liquid Chemical Sterilant Processing System
- K171262 — TempSure
- K171303 — Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
- K171499 — Occlusion Detection Dressing Kit
- K171599 — WiTouch Pro, WiTouch, Neubac
- K171986 — Sterling Supreme Diode Laser
- K172086 — Matira Anterior Cervical System
- K172544 — IV Fat Emulsion Administration Sets
- K172545 — SERI Contour
- K172571 — ULTRASCORE Focused Force PTA Balloon
- K161719 — Salter Labs Bubble Humidifier
- K163462 — AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX
- K170013 — Eztetic BellaTek Encode Healing Abutments
- K170118 — Scanostics UTI Check Application Test System
- K170641 — da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes
- K170705 — ARIX Wrist System
- K170879 — IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories
- K171184 — Persyst Mobile App
- K171232 — PeriView FLEX
- K171804 — Zap-X Radiosurgery System
- K171829 — EndoNaut
- K171852 — DARCO Locking Bone Plate System
- K171891 — ZS3 Ultrasound System, z.one pro Ultrasound System
- K172082 — S60 Series Digital Color Doppler Ultrasound System
- K172219 — Mako Total Knee Application
- K172486 — Anexa Wound Flush, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 120 mL cup, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 100mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 250mL bottle, USP Sterile Water, and USP Sterile Normal Saline (0.9% sodium chloride) 500mL bottle
- K172501 — iNSitu Total Hip System
- K163283 — HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
- K163614 — PENTAX Medical ED34-i10T, Video Duodenoscope
- K170292 — Tri-Ex Extraction Balloon With Multiple Sizing
- K171541 — Powder Free Nitrile Examination Gloves (Orange)
- K171822 — NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
- K171876 — Ceramill Zolid HT+ white
- K172247 — Magic3 Go Intermittent Urinary Catheter
- K172279 — PMT Posterior Fixation System
- K172314 — Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)
- K172521 — PICO Single Use Negative Pressure Wound Therapy System
- K172566 — Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices
- K163135 — Finger Pulse Oximeter
- K163518 — Digital Thermometer
- K163611 — Pain Therapy Device
- K170002 — Medline Blood Collection Set
- K171632 — da Vinci Xi Surgical System
- K171964 — LigaMetrics Suture Anchors
- K172196 — ECOM Cardiac Output Monitoring System
- K172199 — ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
- K172299 — Accordion Piccolo Stone Management Device
- K162828 — Winback Back 3SE
- K163422 — Shanghai Sanyou PEEK Cage System
- K163433 — VITROS Chemistry Products GLU Slides
- K163664 — Health-e-Connect System with IDA
- K170179 — LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
- K170286 — Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
- K172587 — Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers
- K170640 — Endoscope Sterilization Tray
Data sourced from openFDA. This site is unofficial and independent of the FDA.