MEDTRONIC XOMED, INC.

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1045254	1045254	MEDTRONIC XOMED, INC.	1	N	2026-01-01	6743 SOUTHPOINT DR. NORTH Jacksonville FL US 32216
1219071	1000159144	MEDTRONIC XOMED, INC.	1	N	2026-01-01	950 Flanders Rd Mystic CT US 06355

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
5759	1230296185	P820075	LAMICEL(TM)	LOB	1983-06-21
5760	1328856170	K994262	FRONTAL SINUS TREPHINATION CANNULA	KAM	2000-02-08
5760	1062976338	K993021	METRX SYSTEM	HRX	1999-11-10
5760	1062976338	K993021	METRX SYSTEM	HRX	1999-11-10
5760	1397726877	K992869	XOMED BALL-TIP MONOPOLAR STIMULATOR PROBE	ETN	1999-10-07
5760	1503347285	K992855	XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT	QPB	2000-01-21
5760	1459382288	K991560	NASO-LARYNGO-PHARYNGOSCOPE	EOB	1999-07-13
5760	1800596642	K990793	ACCUGUIDE MUSCLE INJECTION MONITOR	GXZ	1999-10-22
5760	1150667316	K983224	XPS DRILL SYSTEM	ERL	1998-10-21
5760	1398418079	K983025	XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT	HRX	1998-11-06
5760	1220465798	K982595	NIM4	ETN	1998-09-04
5760	1853204947	K982594	ENDO-SCRUB/ENDO-SCRUB 2	EOB	1998-08-27
5760	1518194036	K981677	REPOSE BONE SCREW SYSTEM	LRK	1999-08-27
5760	1985956407	K974187	STEALTHSTATION SYSTEM	HAW	1998-01-21
5760	1874109202	K973499	XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEM	HRX	1998-01-30
5760	1113290151	K972398	STEALTHSTATION PASSIVE INSTRUMENT OPTION	HAW	1997-09-16
5760	1381244291	K970910	XOMED SILICONE BLOCK/STRIP	KHJ	1997-05-02
5760	1389091070	K965233	SHARPSITE AC	EOB	1997-04-04
5760	1211614213	K964484	KARTUSH TM PATCHER	KHJ	1997-01-24
5760	1694596679	K963246	TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT	ERL	1996-09-23
5760	1293659564	K961873	ACTIVENT ANTIMICROBIAL VENTILATION TUBES	ETD	1996-07-01
5760	1537758234	K960853	ACE SYSTEM	EQJ	1996-04-03
5760	1847555675	K941407	TYMPANOSTOMY (VENTILATION) TUBE	ETD	1995-03-14
5760	1091938364	K940028	ENDOSCOPE SHEATH	EOB	1995-03-24
5760	1348316892	K934426	NERVE INTEGRITY MONITOR-2 (NIM-2 XL)	ETN	1994-05-13
5760	1821878454	K925640	XOMED-TREACE EMG ENDOTRACHEAL TUBEEN	ETN	1993-08-17
5759	1524360672	K923027	NEURAY SURGICAL PATTIES AND STRIPS	HBA	1992-08-28
5760	1524360672	K923027	NEURAY SURGICAL PATTIES AND STRIPS	HBA	1992-08-28
5760	1505103750	K922880	XOMED TREACE JET VENTILATION TUBE	BTR	1993-04-15
5760	1088917372	K905035	AXOSTIM NERVE STIMULATOR, MODIFICATION	ETN	1991-04-19
5760	1381527794	K904239	SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES	ETA	1991-06-21
5760	1123230857	K902683	SCOPESCRUBBER(TM)	EOB	1990-10-31
5760	1610076387	K901016	LASER-SHIELD II(TM)	GEX	1990-08-29
5760	1171402674	K893491	MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300	FST	1989-06-22
5760	1017462617	K885201	OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT	ETA	1989-04-19
5760	1748122795	K883727	BUCKET PROSTHESIS PORP	ETB	1989-01-13
5760	1306333684	K873964	NICOLET DISPOSABLE PRASS PROBE	ETN	1987-11-20
5760	1615534199	K872112	XOMED PLATINUM WIRE TEFLON PISTION	ETB	1987-07-02
5760	1167792455	K864408	EMG-1, MOTOR NERVE MONITOR	IKN	1987-01-30
5760	1104438664	K852387	GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE	ETD	1986-01-06
5760	1477893542	K850108	EMG SURFACE, DIGITAL RING, BAR, GROUNDING, EEG	GXY	1985-04-11
5760	1296417806	K850107	CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE	GXZ	1985-04-11
5760	1142708686	K844377	SILICONE		1985-03-18
5760	1905094321	K843490	TUBE-STAT	BSR	1984-10-04
5760	1359970956	K834094	AUSTIN ENDOLYMPH DISPERSMENT SHUNT	ESZ	1984-09-20
5760	1359970956	K834094	AUSTIN ENDOLYMPH DISPERSMENT SHUNT	ESZ	1984-09-20
5760	1017533297	K833874	SHEA MIDDLE EAR MICRODRILL	ERL	1984-06-22
5760	1492711029	K833646	PULSATRON NERVE LOCATOR/STIMULATOR	ETN	1984-02-10
5760	1923769795	K823919	TOTAL OSSICULAR REPLACEMENT	ETA	1983-06-24
5760	1792895921	K823917	PARTIAL OSSICULAR REPLACEMENT	ETA	1983-06-24
5760	1478193813	K823912	AUSTIN MODIFIED TOTAL OSSICULAR REPLACE	ETA	1983-06-24
5760	1152509608	K823442	FISCH MODIFIED TOTAL OSSICULAR PROSTHES	LBM	1982-12-03
5760	1276350166	K823441	AUSTIN MODIFIED TOTAL OSSICULAR REPLACE	LBM	1982-12-03
5760	1640889324	K823440	MCGEE MODIFIED STAINLESS STEEL PISTON	ETB	1982-12-03
5760	1537864939	K823429	FISCH MODIFIED TEF-WIRE PISTON	ETB	1982-12-03
5760	1464101632	K822376	TYTAN REUTER BOBBIN VENT TUBE	ETD	1982-09-09
5760	1540164155	K822367	TOTAL	LBN	1982-09-07
5760	1654220784	K810707	CERAVITAL CERAMIC OSSICULAR REPL. PROS.	ETA	1981-06-16
5760	1677538072	K791407	WOMED NICRO-CRAFT POWER SYSTEM	ERL	1979-08-22
5760	1522164796	K790915	JUHN TYM-TAP	FMH	1979-06-27
5760	1029690077	K781529	SEPTAL BUTTON	LFB	1978-10-17
5760	1807958532	K253391	Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)	ONO	2026-03-13
5760	1202799071	K251672	NIM Essence EMG Endotracheal Tube (NIMEID060); NIM Essence EMG Endotracheal Tube (NIMEID065); NIM Essence EMG Endotracheal Tube (NIMEID070); NIM Essence EMG Endotracheal Tube (NIMEID075); NIM Essence EMG Endotracheal Tube (NIMEID080)	ETN	2026-02-10
5760	2015388058	K231580	NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)	ETN	2023-08-30
5760	1800945874	K230320	NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube	ETN	2023-10-26
5760	2002541960	K213246	NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long	ETN	2022-03-21
5760	1116876765	K211269	Visualase MRI-Guided Laser Ablation System (SW 3.4)	ONO	2022-01-07
5760	1354716653	K210841	NuVent Eustachian Tube Dilation Balloon	PNZ	2021-08-16
5760	1260343512	K202623	Novapak Nasal Sinus Packing and Stent	LYA	2020-12-08
5760	1793499444	K200759	NIM Vital, Nerve Integrity Monitor	GWF	2020-10-28
5760	1197060885	K183515	MR8 Drill System, Midas Rex MR8 ClearView Tools	HBC	2019-05-12
5760	1989444160	K182928	CD Horizon Spinal System	NQP	2019-01-11
5760	1989444160	K182928	CD Horizon Spinal System	NQP	2019-01-11
5760	2063811376	K181859	Visualase Thermal Therapy System	LLZ	2019-03-06
5760	1619906160	K173855	Sharpsite AC Rigid Endsocope	EOB	2018-04-20
5760	1797154304	K173249	CD HORIZON Spinal System	NKB	2018-03-08
5760	1797154304	K173249	CD HORIZON Spinal System	NKB	2018-03-08
5760	1937221191	K170312	IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools	HBC	2017-05-15
5760	1360283193	K153391	Sophono Bone Conduction Systems (S) Configuration and (M) Configuration	LXB	2016-06-16
5760	1445476501	K152121	NuVent EM Sinus Dilation System	LRC	2015-12-01
5760	1976775967	K151758	ALAR Nasal Valve Stent	GAT	2015-10-29
5760	1933532402	K151067	Ventilation (Tympanostomy) Tubes	ETD	2015-07-22
5760	1388736099	K150728	XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole	ERL	2015-08-14
5760	1316796612	K132297	EM SINUS DILATION SYSTEM	LRC	2013-11-05
5760	1247290699	K132189	OTOMAG BONE CONDUCATION HEARING SYSTEM	LXB	2013-11-22
5760	1818418474	K130608	QUADCUT	HAW	2013-08-07
5760	1546539000	K123962	OTOMAG BONE CONDUCTION HEARING SYSTEM	LXB	2013-04-08
5760	1936139721	K122391	MEDTRONIC XOMED, INC.	LRK	2013-01-10
5760	1165557419	K121264	TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE	HBE	2012-08-27
5760	1996375831	K112686	NEXT GEN EMG ENDOTRACHEAL TUBE	ETN	2012-06-27
5760	1152260365	K111520	IPC POWEREASE SYSTEM	HBE	2011-10-26
5760	1051079731	K102199	OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)	LXB	2011-05-23
5760	1660330589	K100193	OTOMAG BONE CONDUCTION HEARING SYSTEM	LXB	2010-05-18
5760	1714445851	K090838	STIMULUS/DISSECTION INSTRUMENTS	ETN	2009-07-20
5760	1088880921	K083124	NIM 3.0	GWF	2009-02-27
5760	1372254487	K081475	ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]	HBE	2008-10-17
5760	1890859695	K081277	XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)	ERL	2008-09-05
5760	1304185078	K072315	MIDAS REX CURVED BUR	HBE	2007-09-18
5760	1421127440	K072088	FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS	EOX	2007-08-29
5760	1956694614	K071903	ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE	EOX	2007-08-02
5760	1583975983	K063305	STIMULATING BUR GUARD	ETN	2006-11-29
5760	1580020441	K062996	DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES	GXZ	2007-01-12
5760	1760297151	K062606	CD HORIZON SPINAL SYSTEM	MNI	2006-09-25
5760	1967857740	K062198	SUNSPOTS PRE-GELLED SURFACE ELECTRODES	GXY	2006-12-19
5760	1718478997	K061639	ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON	GWF	2006-11-01
5760	1815593758	K061113	ORTHOMON	GWF	2006-05-23
5760	2045563349	K053087	VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM	GEX	2006-03-01
5760	1526529570	K050798	ECLIPSE NEUROLOGICAL WORKSTATION	GWF	2005-08-15
5760	1903181624	K050194	AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES	GXZ	2005-04-26
5760	1022014563	K050162	CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE	ETN	2005-03-03
5760	1839865637	K043602	QUADRANT RETRACTOR SYSTEM	GAD	2005-02-23
5760	1839865637	K043602	QUADRANT RETRACTOR SYSTEM	GAD	2005-02-23
5760	1835420599	K041985	XPS CURVED BUR	EQJ	2004-08-12
5760	1822596598	K041523	XPS 3000 SYSTEM	ERL	2004-07-23
5760	1538338562	K041413	XPS 3000 SYSTEM	ERL	2004-07-12
5760	1640215753	K041381	MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT	LYA	2004-09-10
5760	1944101131	K031790	SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING	EOB	2003-07-02
5760	1223634052	K031786	TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM	EOX	2003-08-05
5760	1805458508	K031510	NIM-SPINE	ETN	2003-06-18
5760	1087290898	K031003	STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES	ETN	2003-04-11

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
ETN	18	2026-02-10
ERL	10	2015-08-14
EOB	9	2018-04-20
ETA	6	1991-06-21
GWF	5	2020-10-28
LXB	5	2016-06-16
ETD	5	2015-07-22
ETB	5	2000-10-11
HBE	4	2012-08-27
GXZ	4	2007-01-12
HRX	4	1999-11-10
HAW	3	2013-08-07
EOX	3	2007-08-29
ONO	2	2026-03-13
LYA	2	2020-12-08
HBC	2	2019-05-12
NQP	2	2019-01-11
NKB	2	2018-03-08
LRC	2	2015-12-01
LRK	2	2013-01-10
GXY	2	2006-12-19
GEX	2	2006-03-01
GAD	2	2005-02-23
EQJ	2	2004-08-12
IKN	2	2003-01-06
KHJ	2	1997-05-02
HBA	2	1992-08-28
ESZ	2	1984-09-20
LBM	2	1982-12-03
PNZ	1	2021-08-16
LLZ	1	2019-03-06
QDF	1	2018-11-02
GAT	1	2015-10-29
MNI	1	2006-09-25
IKT	1	2001-08-15
KAM	1	2000-02-08
QPB	1	2000-01-21
BTR	1	1993-04-15
FST	1	1989-06-22
BSR	1	1984-10-04