510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Xomed, Inc.

Jacksonville, FL, US

Xomed, Inc. appears in FDA device records in Jacksonville, FL. FDA records list 46 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
46
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 46 510(k) clearances for Xomed, Inc. between 1979 and 2000. The busiest year on record is 2000, with 9. The most recent is 2000, with 9.

Clearances by year, as a table
510(k) clearance decisions for Xomed, Inc., by decision year
YearClearances
19791
19865
19872
19884
19892
19901
19962
19977
19987
19996
20009
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K002395MODEL 30 CLASSIC PNEUMATONOMETERHKXSubstantially Equivalent
K002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEGEISubstantially Equivalent
K002828XPS NITRO SYSTEMERLSubstantially Equivalent
K002897TITANIUM MIDDLE EAR PROSTHESESETBSubstantially Equivalent
K993653MICRO-FRANCE TROCARS AND ACCESSORIESHETSubstantially Equivalent
K001148MEROGEL OTOLOGIC PACKKHJSubstantially Equivalent
K994262FRONTAL SINUS TREPHINATION CANNULAKAMSubstantially Equivalent
K992855XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPTQPBSubstantially Equivalent
K993582MODIFICATION TO LASER-SHIELD IIBTRSubstantially Equivalent
K993655MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUSGEISubstantially Equivalent
K993112XOMED ENT RF SYSTEMGEISubstantially Equivalent
K992869XOMED BALL-TIP MONOPOLAR STIMULATOR PROBEETNSubstantially Equivalent
K992282MICRO-FRANCE LIPOSUCTION CANNULASQPBSubstantially Equivalent
K984363XPS TISSUE ASPIRATION SYSTEM, XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEMBTASubstantially Equivalent
K982731MEROGEL NASAL DRESSING AND SINUS STENTEMXSubstantially Equivalent
K983025XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENTHRXSubstantially Equivalent
K982870EPIFILM OTOLOGIC LAMINAKHJSubstantially Equivalent
K983224XPS DRILL SYSTEMERLSubstantially Equivalent
K982294XOMED SILICONE PRE-FORM BLOCKSKHJSubstantially Equivalent
K982595NIM4ETNSubstantially Equivalent
K982594ENDO-SCRUB/ENDO-SCRUB 2EOBSubstantially Equivalent
K973499XPS STRAIGHTSHOT MICROBRIDER SYSTEM OR TREBAY SHAVER SYSTEMHRXSubstantially Equivalent
K973273XOMED T-STENT, FRONTAL SINUS STENTKAMSubstantially Equivalent
K972453XPS STRAIGHTSHOT MICRORESECTORERLSubstantially Equivalent
K971124TM MICRO-CATHETERSETDSubstantially Equivalent
K970910XOMED SILICONE BLOCK/STRIPKHJSubstantially Equivalent
K965233SHARPSITE ACEOBSubstantially Equivalent
K964909ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESISETBSubstantially Equivalent
K964484KARTUSH TM PATCHERKHJSubstantially Equivalent
K961873ACTIVENT ANTIMICROBIAL VENTILATION TUBESETDSubstantially Equivalent
K960853ACE SYSTEMEQJSubstantially Equivalent
K901016LASER-SHIELD II(TM)GEXSubstantially Equivalent
K884631FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)LRCSubstantially Equivalent
K884834XOMED IONESTHETIZER(TM)EGJUnknown
K884056MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTORLXBSubstantially Equivalent
K882689PUNCH MYRINGOTOMY SYSTEMETDSubstantially Equivalent
K881382XOMED AUDIANT BONE CONDUCTORLXBSubstantially Equivalent
K875277ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.LXBSubstantially Equivalent
K872112XOMED PLATINUM WIRE TEFLON PISTIONETBSubstantially Equivalent
K872168XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.LXBSubstantially Equivalent
K861971XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COILLXBSubstantially Equivalent
K855059AUDIANT BONE CONDUCTOR OR A.B.C.LXBSubstantially Equivalent
K860491OSTEO-MESH CRANIAL FAIRINGSubstantially Equivalent
K853641GODDE T-TUBE BLUE SILICONE TYMPANOSTOMY TUBEETDSubstantially Equivalent
K852387GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBEETDSubstantially Equivalent
K791736MEROCEL INSTRUMENT WIPEGECSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

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Data as of , FDA export datePage updated Source: openFDA, public domain