Panels › Ear, Nose, Throat › Product code ERL · Class 2
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Regulation 874.4250
0510(k)s in 12 months (91 all time)
0recalls in 12 months (29 all time)
26recalls that name a 510(k)
Top companies in ERL
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2025 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessori W&H Dentalwerk Buermoos GmbH, AT | ERL |
| Mar 14, 2024 | K233958 | hekaDrill Zethon, Ltd., GB | ERL |
| Nov 2, 2022 | K221184 | ORiGO System Bien-Air Surgery SA, CH | ERL |
| May 26, 2022 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) W&H Dentalwerk Buermoss GmbH, AT | ERL |
| Jan 19, 2022 | K212650 | Celeris, Disposable Sinus Debrider Gyrus Acmi, Inc. | ERL |
| Jun 9, 2021 | K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 Stryker Corporation | ERL |
| Oct 22, 2020 | K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece KARL STORZ Endoscopy-America, Inc. | ERL |
| Dec 13, 2019 | K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand Interscope, Inc. | ERL |
| Mar 27, 2018 | K180063 | OCM-G1 Attachment The Anspach Effort, Inc. | ERL |
| Sep 15, 2017 | K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 Console Stryker Corporation | ERL |
| Mar 9, 2017 | K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider Laurimed, LLC | ERL |
| Aug 25, 2016 | K161376 | DragonFly Surgical Drill System Grace Medical, Inc. | ERL |
| Jun 22, 2016 | K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) Laurimed, LLC | ERL |
| Jun 10, 2016 | K152744 | DIEGO ELITE DRILL Gyrus Acmi, Inc. | ERL |
| Jan 8, 2016 | K150969 | Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use w Karl Storz Endoscopy America, Inc. | ERL |
| Nov 20, 2015 | K152641 | Pi Drive Plus Motor, Extender Stryker Corporation | ERL |
| Aug 14, 2015 | K150728 | XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole Medtronic Xomed, Inc. | ERL |
| Mar 4, 2015 | K143492 | OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece Bien-Air Surgery SA, CH | ERL |
| Sep 26, 2014 | K141935 | STRYKER S2 DRILL Stryker Corporation | ERL |
| Dec 31, 2013 | K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM The Anspach Effort, Inc. | ERL |
| Dec 23, 2013 | K133133 | LAURIMED POLYPVAC MICRODEBRIDER Laurimed, LLC | ERL |
| Aug 30, 2012 | K121678 | DTAD Gyrus Acmi, Inc. | ERL |
| May 1, 2012 | K112593 | STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM Stryker Corporation | ERL |
| Mar 20, 2009 | K083720 | OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K Bien-Air Surgery SA, CH | ERL |
| Dec 17, 2008 | K081814 | REPROCESSED ENT SHAVERS Sterilmed, Inc. | ERL |
| Oct 2, 2008 | K080052 | STRYKER ESSX WITH NAVIGATION MOUNT Stryker Corp. | ERL |
| Sep 17, 2008 | K080722 | PRIMADO SURGICAL DRILL Nakanishi, Inc. | ERL |
| Sep 5, 2008 | K081277 | XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) Medtronic Xomed, Inc. | ERL |
| Aug 26, 2008 | K073633 | STRYKER ESSX MICRODEBRIDER SYSTEM Stryker Ireland Ltd., Instruments Division, IE | ERL |
| Mar 24, 2008 | K073255 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Dec 19, 2005 | K053262 | KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES KARL STORZ Endoscopy-America, Inc. | ERL |
| Jul 23, 2004 | K041523 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Jul 12, 2004 | K041413 | XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| Mar 3, 2004 | K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) Stryker Instruments | ERL |
| Mar 3, 2004 | K034004 | DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE Gyrus Ent LLC | ERL |
| Jan 28, 2003 | K023070 | SODEM HIGH SPEED SYSTEM (PNEUMATIC) Sodemsystems, CH | ERL |
| Dec 3, 2002 | K021098 | DAUM-LECTRIC MRI DRILLING MACHINE Mri Devices Daum GmbH | ERL |
| Jun 19, 2002 | K021811 | UNIDRIVE II PLUS DISPOSABLE TUBING SET Mtp Medical Technical Promotion GmbH | ERL |
| Mar 8, 2002 | K020594 | DIEGO POWERED DISSECTOR AND DRILL SYSTEM Gyrus Ent LLC | ERL |
| Sep 21, 2001 | K012456 | SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) Sodemsystems, CH | ERL |
| Jun 26, 2001 | K011321 | MODIFICATION TO XPS 3000 SYSTEM Medtronic Xomed, Inc. | ERL |
| May 25, 2001 | K011381 | HUMMER IV MICRODEBRIDER SYSTEM Stryker Instruments | ERL |
| Apr 13, 2001 | K003994 | KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES KARL STORZ Endoscopy-America, Inc. | ERL |
| Dec 4, 2000 | K002224 | XPS 3000 SYSTEM Medtronic Xomed | ERL |
| Oct 17, 2000 | K002828 | XPS NITRO SYSTEM Xomed, Inc. | ERL |
| Nov 23, 1999 | K992994 | TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; Gyrus Ent LLC | ERL |
| Feb 19, 1999 | K990038 | HUMMER TRAK SYSTEM Stryker Endoscopy | ERL |
| Nov 25, 1998 | K983050 | PNEUMATIC CUTTER SYSTEM Surgical Laser Technologies, Inc. | ERL |
| Oct 21, 1998 | K983224 | XPS DRILL SYSTEM Xomed, Inc. | ERL |
| Aug 27, 1998 | K981041 | SLT BIPOLAR SHEATH Surgical Laser Technologies, Inc. | ERL |
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