HRX
ARTHROSCOPE
- Advisory panel
- Orthopedic
- Total cleared
- 679
Adverse events under product code HRX
product code HRX- Injury
- 623
- Malfunction
- 11,257
- Total
- 11,880
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code HRX
1–100 of 679- K252546 — VantageTM Lumbar Decompression Kit
- K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
- K250795 — PUREVUE FMS
- K252666 — Articulator Arthroscopic Bur
- K252458 — Kyphoplasty Balloon Dilatation Catheters
- K252020 — TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
- K252594 — UltraGuideCTR® image guided soft tissue release system
- K243774 — ELID (Endoscopic Less Invasive Decompression) System
- K241990 — SpineSite Endoscope System
- K243602 — Arthrex Spine Endoscope
- K242417 — VECTR Video Endoscopic Carpal Tunnel Release System
- K243020 — MIDASVu
- K233800 — Vertos mild Device Kit (MDK-0002)
- K240535 — Digital ClarusScope System; Digital NeuroPEN System
- K233675 — FMS VUE Fluid Management and Tissue Debridement System
- K233115 — Hawkeye Control Unit with Eyas Endoscope
- K223709 — Kyphoplasty Balloon Catheter
- K221142 — Kyphoplasty Balloon System
- K221919 — DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets
- K223406 — SmartRelease Endoscopic Soft Tissue Release System
- K223244 — Pristine Arthroscopic Visualization System
- K222490 — HBL Blade Assembly
- K213978 — TELIGEN System
- K212636 — CORUS Spinal System-X
- K212556 — mi-eye 3 needlescope with cannula, mi-tablet 3
- K211297 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K203480 — DOUBLEFLO system
- K202027 — Balex bone Expander System
- K193608 — EBERLE Shaver System C3 and Accessories
- K203526 — C Scope Visualization System
- K201113 — Resascope RS-01/B
- K202659 — Stryker Arthroscope
- K192921 — Zeos Aqua Vision Pump and tube
- K200067 — MectaScope System
- K200763 — Osteo-site Vertebral Balloon
- K201349 — Smith+Nephew Arthroscopes
- K200729 — HydroCision SpineJet System
- K191596 — Arcadia Balloon Catheter
- K192155 — Smith & Nephew DYONICS 25 Fluid Management System
- K191345 — Pegasus System
- K191259 — Stryker CrossFlow Integrated Arthroscopy Pump
- K191579 — Voyant System
- K191594 — Nuvis Battery Arthroscope
- K190804 — HydroCision TenJet Device
- K182287 — MEDINAUT Plus
- K190598 — CROSSWAY Spinal Access System
- K190201 — CORUS Spinal System
- K183165 — Pristine Scope
- K183470 — Precision Ideal Eyes Arthroscopes
- K181752 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K182882 — CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
- K181819 — SMARTRELEASE Endoscopic Soft Tissue Release System
- K181885 — Voyant System
- K181982 — MIDAScope and Introducer Kit, and MIDASystem
- K180766 — Endiscope, Endiscope Cervical
- K170703 — Single Use Arthroscopic Electrode (with Pencil)
- K180876 — DTRAX Spinal System
- K173311 — ARTHRO-Pump PA304
- K180315 — DISKOM
- K172116 — Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)
- K171237 — FMS VUE II Fluid Management and Tissue Debridement System
- K172092 — Reprocessed Shavers/Burs
- K171794 — Smith & Nephew 25 Fluid Management System
- K162070 — JOINIX CANNULAR SYSTEM
- K163037 — Intra medullary endo-transilluminating device (iMET device)
- K162062 — AVAmax Vertebral Balloon, AVAflex Vertebral Balloon
- K161878 — PORTAGE System
- K162475 — mi-eye 2, mi-eye 2 monitor
- K152511 — Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
- K160249 — ULTRA Telescopes
- K151932 — Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing
- K151268 — SPINAUT-V, SPINAUT-S, SPINAUT-I
- K153548 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K151125 — AVAflex Vertebral Balloon System
- K150523 — AVAmax Vertebral Balloon
- K151532 — KYPHON ELEMENT Inflatable Bone Tamp
- K143705 — NeedleCam HD Visualization System
- K141557 — HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR
- K141326 — NEEDLE VIEW CH SCOPE KITS
- K141119 — CAMERA ENABLED PROBE
- K140903 — NUVIS ARTHROSCOPE
- K141002 — VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM
- K133682 — SCHOELLY ARTHROSCOPE
- K133941 — MITEK ARTHROSCOPES
- K130778 — DISCOSCOPES, CERVICAL ENDOSCOPES
- K133018 — OSI Q SYSTEM ARTHROSCOPES
- K133061 — ESPIN SYSTEM
- K132883 — HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS)
- K131820 — AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11G
- K131824 — AVAFLEX VERTEBRAL BALLOON SYSTEM
- K131191 — 4MM & 5MM FULL RADIUS BLADE PLUS, 4MM & 5MM BARREL BUR PLUS/4MM BARREL TORNADO BUR PLUS, 4MM & 5MM AGGRESSIVE BLADE PLUS
- K130912 — OMNICUT RESECTION BLADE
- K130430 — IVAS 10MM AND 15MM BALLOON CATHETER
- K130169 — FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE
- K122411 — J-SCOPE SYSTEM
- K130057 — ESPIN
- K123441 — STRYKER CROSSFLOW ARTHROSCOPY PUMP
- K121261 — ASAP MUITISCOPE
- K122134 — FLEXLITE CAMERA
- K123771 — KYPHON EXPRESS II INFLATABLE BONE TAMPS
Data sourced from openFDA. This site is unofficial and independent of the FDA.