ERL · Class II · 21 CFR 874.4250

FDA Product Code ERL: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

Leading manufacturers include Medtronic Xomed, Inc., Stryker Corporation and Xomed, Inc..

91
Total
91
Cleared
100d
Avg days
1978
Since
91 devices
25–48 of 91
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814
Sterilmed, Inc.
Ear, Nose, Throat · 174d
Cleared Oct 02, 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052
Stryker Corp.
Ear, Nose, Throat · 268d
Cleared Sep 17, 2008
PRIMADO SURGICAL DRILL
K080722
Nakanishi, Inc.
Ear, Nose, Throat · 188d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277
Medtronic Xomed, Inc.
Ear, Nose, Throat · 123d
Cleared Aug 26, 2008
STRYKER ESSX MICRODEBRIDER SYSTEM
K073633
Stryker Ireland Ltd., Instruments Division
Ear, Nose, Throat · 244d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255
Medtronic Xomed, Inc.
Ear, Nose, Throat · 126d
Cleared Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 27d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523
Medtronic Xomed, Inc.
Ear, Nose, Throat · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413
Medtronic Xomed, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004
Gyrus Ent LLC
Ear, Nose, Throat · 70d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300
Stryker Instruments
Ear, Nose, Throat · 23d
Cleared Jan 28, 2003
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070
Sodemsystems
Ear, Nose, Throat · 134d
Cleared Dec 03, 2002
DAUM-LECTRIC MRI DRILLING MACHINE
K021098
Mri Devices Daum GmbH
Ear, Nose, Throat · 243d
Cleared Jun 19, 2002
UNIDRIVE II PLUS DISPOSABLE TUBING SET
K021811
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 16d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594
Gyrus Ent LLC
Ear, Nose, Throat · 14d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456
Sodemsystems
Ear, Nose, Throat · 51d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 108d
Cleared Dec 04, 2000
XPS 3000 SYSTEM
K002224
Medtronic Xomed
Ear, Nose, Throat · 133d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828
Xomed, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 23, 1999
TURBO 7000 SHAVER AND DRILL CONSOLE
K992994
Gyrus Ent LLC
Ear, Nose, Throat · 77d
Cleared Feb 19, 1999
HUMMER TRAK SYSTEM
K990038
Stryker Endoscopy
Ear, Nose, Throat · 44d
Cleared Nov 25, 1998
PNEUMATIC CUTTER SYSTEM
K983050
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 85d