FDA 510(k) clearances — page 219
clearances on record, most recent first.
Clearances — page 219
21,801–21,900 of 176,542- K192442 — FFRangio
- K192522 — TSV BellaTek Express and BellaTek Flex Abutments
- K192885 — C.T.M. Mobility Scooter HS-268
- K190273 — T3 Platform software
- K192279 — PhantomMSK Trauma
- K183052 — ID-Cap System
- K190382 — Intraocular Pressure Tonometer EASYTON
- K190552 — JJ Implant System
- K190612 — EQUINOX Balloon Dilatation Catheter
- K190656 — Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings
- K191239 — Smart Peak Flow Meter
- K191279 — Disposable SpO2 Sensor
- K191861 — Aurora Surgiscope System
- K192324 — Sheridan Spiral-Flex Endotracheal Tubes
- K192443 — Dextile Anatomical Mesh
- K192521 — Intense Pulsed Light Treatment System
- K192773 — ALLIVE
- K193030 — Avenir Muller Stem, Avenir Cemented Hip Stem
- DEN190016 — cobas vivoDx MRSA
- K182758 — MCI - CMF System
- K190660 — G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene
- K191191 — Neodent Implant System - Temporary Abutments
- K191250 — Southern Implants PEEK Abutments
- K191760 — PICO 14 Single Use Negative Pressure Wound Therapy System
- K191804 — TOMi Scope
- K191864 — 21HK512D
- K191962 — Vitra 2
- K191996 — BC Reflex Uni Knee System
- K192224 — BTL-899
- K192482 — Elekta Unity
- K192766 — Digital Intraoral Imaging Plate System
- K193028 — MEDRAD Mark 7 Arterion Injection System
- K191371 — MolecuLight i:X
- K191379 — RELiZORB
- K191759 — Medline Quick Switch Valve with ENFit Connector
- K192335 — TRACKER Kyphoplasty System
- K192348 — SICAT Implant V2.0
- K192430 — Epic 980
- K193020 — VenaPro Vascular Therapy System
- K193068 — AIROS 8 Sequential Compression Device
- K193069 — AIROS 6 Sequential Compression Device
- K183371 — Deka Tiac 1
- K191522 — Straumann Modular Cassette
- K192132 — SeaSpine Beachside System
- K192473 — Exsomed Wrist Plating System
- K192528 — CO2 Laser Therapy System
- K193009 — Promisemed Heel Blood Lancet
- K193083 — M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System
- K193107 — TriSalus Infusion System
- K193160 — Glidesheath Slender Tibial Pedal Kit
- DEN180014 — WOUNDCHEK Bacterial Status
- K182819 — Decanting Device
- K183622 — NasalCEASE and BleedCEASE
- K190009 — Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
- K190588 — Integra TITAN Reverse Shoulder System
- K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
- K190876 — mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed
- K190987 — Uroject12 Syringe Lever
- K191088 — Checkme O2 Pulse Oximeter
- K191656 — Zipbond
- K191722 — Vital Navigation System
- K192038 — Emprint Visualization Application
- K192374 — Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip
- K192394 — Hi-Fatigue Bone Cement
- K192666 — Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
- K193040 — Resorbable Mesh Device
- K190710 — EliA SymphonyS Immunoassay
- K192105 — Innonix Antiviral Child's Face Mask
- K192186 — I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph
- K192365 — Shoulder Innovations Total Shoulder System
- K192782 — ASAHI CROSSWALK Peripheral Support Catheter
- K193034 — AXS Infinity LS Plus Long Sheath
- K190577 — World Knee Total Knee Systems
- K190811 — Optimus NEURO System - Sterile Kit
- K190955 — Hypotension Decision Assist
- K191032 — fMRI Hardware System
- K191428 — ECG Cable
- K191673 — Upper Arm Blood Pressure Monitor
- K191911 — 3Shape Splint Design
- K191987 — Orapeutic
- K192079 — EOSedge
- K192379 — Hi-Fatigue G Bone Cement
- K192438 — Rhythmia HDxTM Mapping System
- K192468 — Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter +4 more
- K192519 — Multi-modality workstation
- K192791 — Diagnostic Ultrasound System
- K192945 — 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
- K182892 — TRAUS Dental Handpieces
- K190911 — Physica KR Liner and SMR Reverse Humeral Liner
- K191426 — FiberTak Button
- K191502 — Heraeus Peripheral Guidewire
- K191961 — OrthoGold
- K192026 — Peridot Intervertebral body fusion System
- K192271 — Access PCT, Access PCT Calibrators
- K192320 — HealthCXR
- K192367 — Ion Endoluminal System
- K192376 — Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
- K192396 — Streamline MIS Spinal Fixation System
- K192417 — ARIX Cannulated Screw System
- K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
Data sourced from openFDA. This site is unofficial and independent of the FDA.