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
73–91 of 91
Cleared Nov 22, 1994
EDI-BUR MICRODRILL SYSTEMS
K945438
Micromed Development Corp.
Ear, Nose, Throat · 33d
Cleared Nov 18, 1994
APEX UNIVERSAL DRIVE SYSTEM
K944476
Linvatec Corp.
Ear, Nose, Throat · 67d
Cleared Aug 17, 1994
MEDNEXT MICRO-DRILL
K943108
Mednext, Inc.
Ear, Nose, Throat · 49d
Cleared May 16, 1994
STRYKER MICRODEBRIDER SYSTEM
K940710
Stryker Corp.
Ear, Nose, Throat · 88d
Cleared Nov 27, 1991
DRILL MODULES MODELS 2116/2117
K914346
Micro Surgical Instruments Corp.
Ear, Nose, Throat · 61d
Cleared Apr 22, 1991
X-T AIR DRILL
K905800
Xomed-Treace, Inc.
Ear, Nose, Throat · 115d
Cleared Sep 04, 1987
TREACE MAGNUM OTO-TOOL SYSTEM
K873154
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Aug 15, 1986
TREACE DRILL SYSTEM
K862807
Treace Medical, Inc.
Ear, Nose, Throat · 23d
Cleared Jan 21, 1986
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K854331
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 21, 1986
MICRO-AIRE STAPES DRILL SYSTEM
K854332
Micro-Aire Surgical Instruments, Inc.
Ear, Nose, Throat · 85d
Cleared Aug 10, 1984
TISSUE INTEGRATED PROSTHESIS DRILL
K841813
Bofors Nobelpharma, Inc.
Ear, Nose, Throat · 101d
Cleared Jun 22, 1984
SHEA MIDDLE EAR MICRODRILL
K833874
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
SHEA FOOTPLATE MICRODRILL
K833875
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Nov 03, 1983
SURGICAL DRILL-ELECTRIC-HANDPIECE
K831946
Entronics
Ear, Nose, Throat · 140d
Cleared Aug 12, 1982
TORX OR TYPE MICRO MOTOR HANDPIECE
K822008
Kelleher Corp.
Ear, Nose, Throat · 35d
Cleared Nov 27, 1979
FISCH DRILL SYSTEM
K792159
Jedmed Instrument Co.
Ear, Nose, Throat · 29d
Cleared Aug 22, 1979
WOMED NICRO-CRAFT POWER SYSTEM
K791407
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 31, 1978
XOMED TRANSSPHENOIDAL HANDPIECE
K781418
Xomed, Inc.
Ear, Nose, Throat · 15d