Product code ERL— Ear, Nose, Throat
XPS 3000 SYSTEM
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 91
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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 ERL
- K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- K233958 — hekaDrill
- K221184 — ORiGO System
- K213221 — AMADEO, M-UK1015 (incl. attachments and accessories)
- K212650 — Celeris, Disposable Sinus Debrider
- K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
- K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
- K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
- K180063 — OCM-G1 Attachment
- K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console
- K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
- K161376 — DragonFly Surgical Drill System
- K161101 — PolypVac Microdebrider (3.3mm and 4.0mm)
- K152744 — DIEGO ELITE DRILL
- K150969 — Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
- K152641 — Pi Drive Plus Motor, Extender
- K150728 — XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
- K143492 — OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
- K141935 — STRYKER S2 DRILL
- K131053 — ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
- K133133 — LAURIMED POLYPVAC MICRODEBRIDER
- K121678 — DTAD
- K112593 — STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K083720 — OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
- K081814 — REPROCESSED ENT SHAVERS
- K080052 — STRYKER ESSX WITH NAVIGATION MOUNT
- K080722 — PRIMADO SURGICAL DRILL
- K081277 — XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
- K073633 — STRYKER ESSX MICRODEBRIDER SYSTEM
- K073255 — XPS 3000 SYSTEM
- K053262 — KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
- K041523 — XPS 3000 SYSTEM
- K041413 — XPS 3000 SYSTEM
- K034004 — DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
- K040300 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
- K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC)
- K021098 — DAUM-LECTRIC MRI DRILLING MACHINE
- K021811 — UNIDRIVE II PLUS DISPOSABLE TUBING SET
- K020594 — DIEGO POWERED DISSECTOR AND DRILL SYSTEM
- K012456 — SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
- K011321 — MODIFICATION TO XPS 3000 SYSTEM
- K011381 — HUMMER IV MICRODEBRIDER SYSTEM
- K003994 — KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
- K002224 — XPS 3000 SYSTEM
- K002828 — XPS NITRO SYSTEM
- K992994 — TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
- K990038 — HUMMER TRAK SYSTEM
- K983050 — PNEUMATIC CUTTER SYSTEM
- K983224 — XPS DRILL SYSTEM
- K981041 — SLT BIPOLAR SHEATH
- K981637 — INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
- K974174 — ULTRABUR
- K972057 — POWERTREK INSTRUMENTS
- K972584 — STRYKER HUMMER II MICRODEBRIDER SYSTEM
- K972865 — PROMEX ENT TISSUE REMOVAL SYSTEM
- K973286 — ENT IRRIGATING PUMP (70327700)
- K972453 — XPS STRAIGHTSHOT MICRORESECTOR
- K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
- K964548 — APEX UNIVERSAL DRIVE SYSTEM
- K965080 — ANSPACH MICROMAX SYSTEM
- K963246 — TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
- K962163 — MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
- K961192 — IRRIGATION SYSTEM
- K954989 — DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
- K954796 — MICRO-INGRESSOR HANDIPIECE
- K954715 — MICRO-PLANER HANDPIECE
- K952681 — STRYKER HUMMER II MICRODEBRIDER SYSTEM
- K951263 — INTRAARC DRIVE SYSTEM
- K950964 — KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
- K943569 — STRYKER TOTAL PERFORMANCE SYSTEM
- K945659 — BLACKSTAR(TM) STAR SYSTEM
- K940016 — ELECTRIC SURGICAL DRILL
- K945438 — EDI-BUR MICRODRILL SYSTEMS
- K944476 — APEX UNIVERSAL DRIVE SYSTEM
- K943108 — MEDNEXT MICRO-DRILL
- K940710 — STRYKER MICRODEBRIDER SYSTEM
- K914346 — DRILL MODULES MODELS 2116/2117
- K905800 — X-T AIR DRILL
- K873154 — TREACE MAGNUM OTO-TOOL SYSTEM
- K862807 — TREACE DRILL SYSTEM
- K854331 — MICRO-AIRE OTO/NEURO DRILL SYSTEM
- K854332 — MICRO-AIRE STAPES DRILL SYSTEM
- K841813 — TISSUE INTEGRATED PROSTHESIS DRILL
- K833874 — SHEA MIDDLE EAR MICRODRILL
- K833875 — SHEA FOOTPLATE MICRODRILL
- K831946 — SURGICAL DRILL-ELECTRIC-HANDPIECE
- K822008 — TORX OR TYPE MICRO MOTOR HANDPIECE
- K802463 — MICRO-SURGICAL POWER INSTRUMENT SYSTEM
- K792159 — FISCH DRILL SYSTEM
- K791407 — WOMED NICRO-CRAFT POWER SYSTEM
- K781418 — XOMED TRANSSPHENOIDAL HANDPIECE
Data sourced from openFDA. This site is unofficial and independent of the FDA.