ClearanceBrief
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)
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Top companies in ERL

Decided510(k)Device and applicantCode
Jul 20, 1998K981637INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
Linvatec Corp.
ERL
Mar 10, 1998K974174ULTRABUR
Mednet Locator, Inc.
ERL
Nov 5, 1997K972057POWERTREK INSTRUMENTS
Medtrek Corp.
ERL
Oct 1, 1997K972584STRYKER HUMMER II MICRODEBRIDER SYSTEM
Stryker Endoscopy
ERL
Sep 29, 1997K973286ENT IRRIGATING PUMP (70327700)
Gyrus Ent LLC
ERL
Sep 29, 1997K972865PROMEX ENT TISSUE REMOVAL SYSTEM
Promex, Inc.
ERL
Sep 5, 1997K972453XPS STRAIGHTSHOT MICRORESECTOR
Xomed, Inc.
ERL
Apr 9, 1997K970965MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
Midas Rex Pneumatic Tools, Inc.
ERL
Jan 17, 1997K964548APEX UNIVERSAL DRIVE SYSTEM
Linvatec Corp.
ERL
Jan 10, 1997K965080ANSPACH MICROMAX SYSTEM
The Anspach Effort, Inc.
ERL
Sep 23, 1996K963246TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
Medtronic Xomed
ERL
Jul 25, 1996K962163MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
Misten Medical Corp.
ERL
Apr 26, 1996K961192IRRIGATION SYSTEM
Linvatec Corp.
ERL
Nov 27, 1995K954989DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
Smith & Nephew Dyonics, Inc.
ERL
Nov 6, 1995K954796MICRO-INGRESSOR HANDIPIECE
Trebay Medical Corp.
ERL
Oct 27, 1995K954715MICRO-PLANER HANDPIECE
Trebay Medical Corp.
ERL
Jul 20, 1995K952681STRYKER HUMMER II MICRODEBRIDER SYSTEM
Stryker Endoscopy
ERL
Apr 17, 1995K951263INTRAARC DRIVE SYSTEM
Linvatec Corp.
ERL
Mar 24, 1995K950964KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
KARL STORZ Endoscopy-America, Inc.
ERL
Jan 9, 1995K945659BLACKSTAR(TM) STAR SYSTEM
Xomed-Treace, Inc.
ERL
Jan 9, 1995K943569STRYKER TOTAL PERFORMANCE SYSTEM
Stryker Corp.
ERL
Nov 22, 1994K945438EDI-BUR MICRODRILL SYSTEMS
Micromed Development Corp.
ERL
Nov 22, 1994K940016ELECTRIC SURGICAL DRILL
Alamo City Dental Supply Co.
ERL
Nov 18, 1994K944476APEX UNIVERSAL DRIVE SYSTEM
Linvatec Corp.
ERL
Aug 17, 1994K943108MEDNEXT MICRO-DRILL
Mednext, Inc.
ERL
May 16, 1994K940710STRYKER MICRODEBRIDER SYSTEM
Stryker Corp.
ERL
Nov 27, 1991K914346DRILL MODULES MODELS 2116/2117
Micro Surgical Instruments Corp.
ERL
Apr 22, 1991K905800X-T AIR DRILL
Xomed-Treace, Inc.
ERL
Sep 4, 1987K873154TREACE MAGNUM OTO-TOOL SYSTEM
Treace Medical, Inc.
ERL
Aug 15, 1986K862807TREACE DRILL SYSTEM
Treace Medical, Inc.
ERL
Jan 21, 1986K854332MICRO-AIRE STAPES DRILL SYSTEM
Micro-Aire Surgical Instruments, Inc.
ERL
Jan 21, 1986K854331MICRO-AIRE OTO/NEURO DRILL SYSTEM
Micro-Aire Surgical Instruments, Inc.
ERL
Aug 10, 1984K841813TISSUE INTEGRATED PROSTHESIS DRILL
Bofors Nobelpharma, Inc.
ERL
Jun 22, 1984K833875SHEA FOOTPLATE MICRODRILL
Applied Research Corp.
ERL
Jun 22, 1984K833874SHEA MIDDLE EAR MICRODRILL
Applied Research Corp.
ERL
Nov 3, 1983K831946SURGICAL DRILL-ELECTRIC-HANDPIECE
Entronics
ERL
Aug 12, 1982K822008TORX OR TYPE MICRO MOTOR HANDPIECE
Kelleher Corp.
ERL
Oct 31, 1980K802463MICRO-SURGICAL POWER INSTRUMENT SYSTEM
Spire Medical, Inc.
ERL
Nov 27, 1979K792159FISCH DRILL SYSTEM
Jedmed Instrument Co.
ERL
Aug 22, 1979K791407WOMED NICRO-CRAFT POWER SYSTEM
Xomed, Inc.
ERL
Aug 31, 1978K781418XOMED TRANSSPHENOIDAL HANDPIECE
Xomed, Inc.
ERL

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