| Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (K243280) | W&H Dentalwerk Buermoos GmbH | 2025-07-03 |
| hekaDrill (K233958) | Zethon, Ltd. | 2024-03-14 |
| ORiGO System (K221184) | Bien-Air Surgery SA | 2022-11-02 |
| AMADEO, M-UK1015 (incl. attachments and accessories) (K213221) | W&H Dentalwerk Buermoss GmbH | 2022-05-26 |
| Celeris, Disposable Sinus Debrider (K212650) | Gyrus Acmi, Inc. | 2022-01-19 |
| Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 (K211490) | Stryker Corporation | 2021-06-09 |
| UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece (K200318) | KARL STORZ Endoscopy-America, Inc. | 2020-10-22 |
| EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand (K190715) | Interscope, Inc. | 2019-12-13 |
| OCM-G1 Attachment (K180063) | The Anspach Effort, Inc. | 2018-03-27 |
| Stryker Consolidated Operating Room Equipment (CORE) 2 Console (K171840) | Stryker Corporation | 2017-09-15 |
| 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (K163247) | Laurimed, LLC | 2017-03-09 |
| DragonFly Surgical Drill System (K161376) | Grace Medical, Inc. | 2016-08-25 |
| PolypVac Microdebrider (3.3mm and 4.0mm) (K161101) | Laurimed, LLC | 2016-06-22 |
| DIEGO ELITE DRILL (K152744) | Gyrus Acmi, Inc. | 2016-06-10 |
| 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 (K150969) | Karl Storz Endoscopy America, Inc. | 2016-01-08 |
| Pi Drive Plus Motor, Extender (K152641) | Stryker Corporation | 2015-11-20 |
| XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole (K150728) | Medtronic Xomed, Inc. | 2015-08-14 |
| OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece (K143492) | Bien-Air Surgery SA | 2015-03-04 |
| STRYKER S2 DRILL (K141935) | Stryker Corporation | 2014-09-26 |
| ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM (K131053) | The Anspach Effort, Inc. | 2013-12-31 |
| LAURIMED POLYPVAC MICRODEBRIDER (K133133) | Laurimed, LLC | 2013-12-23 |
| DTAD (K121678) | Gyrus Acmi, Inc. | 2012-08-30 |
| STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM (K112593) | Stryker Corporation | 2012-05-01 |
| OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K (K083720) | Bien-Air Surgery SA | 2009-03-20 |
| REPROCESSED ENT SHAVERS (K081814) | Sterilmed, Inc. | 2008-12-17 |
| STRYKER ESSX WITH NAVIGATION MOUNT (K080052) | Stryker Corp. | 2008-10-02 |
| PRIMADO SURGICAL DRILL (K080722) | Nakanishi, Inc. | 2008-09-17 |
| XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) (K081277) | Medtronic Xomed, Inc. | 2008-09-05 |
| STRYKER ESSX MICRODEBRIDER SYSTEM (K073633) | Stryker Ireland Ltd., Instruments Division | 2008-08-26 |
| XPS 3000 SYSTEM (K073255) | Medtronic Xomed, Inc. | 2008-03-24 |
| KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES (K053262) | KARL STORZ Endoscopy-America, Inc. | 2005-12-19 |
| XPS 3000 SYSTEM (K041523) | Medtronic Xomed, Inc. | 2004-07-23 |
| XPS 3000 SYSTEM (K041413) | Medtronic Xomed, Inc. | 2004-07-12 |
| STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) (K040300) | Stryker Instruments | 2004-03-03 |
| DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE (K034004) | Gyrus Ent LLC | 2004-03-03 |
| SODEM HIGH SPEED SYSTEM (PNEUMATIC) (K023070) | Sodemsystems | 2003-01-28 |
| DAUM-LECTRIC MRI DRILLING MACHINE (K021098) | Mri Devices Daum GmbH | 2002-12-03 |
| UNIDRIVE II PLUS DISPOSABLE TUBING SET (K021811) | Mtp Medical Technical Promotion GmbH | 2002-06-19 |
| DIEGO POWERED DISSECTOR AND DRILL SYSTEM (K020594) | Gyrus Ent LLC | 2002-03-08 |
| SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) (K012456) | Sodemsystems | 2001-09-21 |
| MODIFICATION TO XPS 3000 SYSTEM (K011321) | Medtronic Xomed, Inc. | 2001-06-26 |
| HUMMER IV MICRODEBRIDER SYSTEM (K011381) | Stryker Instruments | 2001-05-25 |
| KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES (K003994) | KARL STORZ Endoscopy-America, Inc. | 2001-04-13 |
| XPS 3000 SYSTEM (K002224) | Medtronic Xomed | 2000-12-04 |
| XPS NITRO SYSTEM (K002828) | Xomed, Inc. | 2000-10-17 |
| TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS; (K992994) | Gyrus Ent LLC | 1999-11-23 |
| HUMMER TRAK SYSTEM (K990038) | Stryker Endoscopy | 1999-02-19 |
| PNEUMATIC CUTTER SYSTEM (K983050) | Surgical Laser Technologies, Inc. | 1998-11-25 |
| XPS DRILL SYSTEM (K983224) | Xomed, Inc. | 1998-10-21 |
| SLT BIPOLAR SHEATH (K981041) | Surgical Laser Technologies, Inc. | 1998-08-27 |
| INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY (K981637) | Linvatec Corp. | 1998-07-20 |
| ULTRABUR (K974174) | Mednet Locator, Inc. | 1998-03-10 |
| POWERTREK INSTRUMENTS (K972057) | Medtrek Corp. | 1997-11-05 |
| STRYKER HUMMER II MICRODEBRIDER SYSTEM (K972584) | Stryker Endoscopy | 1997-10-01 |
| PROMEX ENT TISSUE REMOVAL SYSTEM (K972865) | Promex, Inc. | 1997-09-29 |
| ENT IRRIGATING PUMP (70327700) (K973286) | Gyrus Ent LLC | 1997-09-29 |
| XPS STRAIGHTSHOT MICRORESECTOR (K972453) | Xomed, Inc. | 1997-09-05 |
| MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (K970965) | Midas Rex Pneumatic Tools, Inc. | 1997-04-09 |
| APEX UNIVERSAL DRIVE SYSTEM (K964548) | Linvatec Corp. | 1997-01-17 |
| ANSPACH MICROMAX SYSTEM (K965080) | The Anspach Effort, Inc. | 1997-01-10 |
| TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT (K963246) | Medtronic Xomed | 1996-09-23 |
| MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL (K962163) | Misten Medical Corp. | 1996-07-25 |
| IRRIGATION SYSTEM (K961192) | Linvatec Corp. | 1996-04-26 |
| DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES (K954989) | Smith & Nephew Dyonics, Inc. | 1995-11-27 |
| MICRO-INGRESSOR HANDIPIECE (K954796) | Trebay Medical Corp. | 1995-11-06 |
| MICRO-PLANER HANDPIECE (K954715) | Trebay Medical Corp. | 1995-10-27 |
| STRYKER HUMMER II MICRODEBRIDER SYSTEM (K952681) | Stryker Endoscopy | 1995-07-20 |
| INTRAARC DRIVE SYSTEM (K951263) | Linvatec Corp. | 1995-04-17 |
| KARL STORZ INTRA-HANDPIECES AND ACCESSORIES (K950964) | KARL STORZ Endoscopy-America, Inc. | 1995-03-24 |
| BLACKSTAR(TM) STAR SYSTEM (K945659) | Xomed-Treace, Inc. | 1995-01-09 |
| STRYKER TOTAL PERFORMANCE SYSTEM (K943569) | Stryker Corp. | 1995-01-09 |
| EDI-BUR MICRODRILL SYSTEMS (K945438) | Micromed Development Corp. | 1994-11-22 |
| ELECTRIC SURGICAL DRILL (K940016) | Alamo City Dental Supply Co. | 1994-11-22 |
| APEX UNIVERSAL DRIVE SYSTEM (K944476) | Linvatec Corp. | 1994-11-18 |
| MEDNEXT MICRO-DRILL (K943108) | Mednext, Inc. | 1994-08-17 |
| STRYKER MICRODEBRIDER SYSTEM (K940710) | Stryker Corp. | 1994-05-16 |
| DRILL MODULES MODELS 2116/2117 (K914346) | Micro Surgical Instruments Corp. | 1991-11-27 |
| X-T AIR DRILL (K905800) | Xomed-Treace, Inc. | 1991-04-22 |
| TREACE MAGNUM OTO-TOOL SYSTEM (K873154) | Treace Medical, Inc. | 1987-09-04 |
| TREACE DRILL SYSTEM (K862807) | Treace Medical, Inc. | 1986-08-15 |
| MICRO-AIRE OTO/NEURO DRILL SYSTEM (K854331) | Micro-Aire Surgical Instruments, Inc. | 1986-01-21 |
| MICRO-AIRE STAPES DRILL SYSTEM (K854332) | Micro-Aire Surgical Instruments, Inc. | 1986-01-21 |
| TISSUE INTEGRATED PROSTHESIS DRILL (K841813) | Bofors Nobelpharma, Inc. | 1984-08-10 |
| SHEA FOOTPLATE MICRODRILL (K833875) | Applied Research Corp. | 1984-06-22 |
| SHEA MIDDLE EAR MICRODRILL (K833874) | Applied Research Corp. | 1984-06-22 |
| SURGICAL DRILL-ELECTRIC-HANDPIECE (K831946) | Entronics | 1983-11-03 |
| TORX OR TYPE MICRO MOTOR HANDPIECE (K822008) | Kelleher Corp. | 1982-08-12 |
| MICRO-SURGICAL POWER INSTRUMENT SYSTEM (K802463) | Spire Medical, Inc. | 1980-10-31 |
| FISCH DRILL SYSTEM (K792159) | Jedmed Instrument Co. | 1979-11-27 |
| WOMED NICRO-CRAFT POWER SYSTEM (K791407) | Xomed, Inc. | 1979-08-22 |
| XOMED TRANSSPHENOIDAL HANDPIECE (K781418) | Xomed, Inc. | 1978-08-31 |