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 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 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 Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594
Gyrus Ent LLC
Ear, Nose, Throat · 14d
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 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
Cleared Oct 21, 1998
XPS DRILL SYSTEM
K983224
Xomed, Inc.
Ear, Nose, Throat · 37d
Cleared Aug 27, 1998
SLT BIPOLAR SHEATH
K981041
Surgical Laser Technologies, Inc.
Ear, Nose, Throat · 160d
Cleared Jul 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637
Linvatec Corp.
Ear, Nose, Throat · 73d
Cleared Mar 10, 1998
ULTRABUR
K974174
Mednet Locator, Inc.
Ear, Nose, Throat · 124d
Cleared Nov 05, 1997
POWERTREK INSTRUMENTS
K972057
Medtrek Corp.
Ear, Nose, Throat · 156d
Cleared Oct 01, 1997
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K972584
Stryker Endoscopy
Ear, Nose, Throat · 83d
Cleared Sep 29, 1997
PROMEX ENT TISSUE REMOVAL SYSTEM
K972865
Promex, Inc.
Ear, Nose, Throat · 56d