FDA.reportPublic FDA data

SUMMIT MEDICAL, INC.

Matched from indexed company URL: SUMMIT MEDICAL LIMITED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12226371000120904SUMMIT MEDICAL, INC.1N2026-01-0120 ADDISON AVE. FRANKLIN MA US 02038
30087190173008719017SUMMIT MEDICAL LLC1Y2026-01-01815 Vikings Pkwy Ste 100 Saint Paul MN US 55121
17222141000117099Summit Medical Products, inc1Y2020-04-25504 West 8360 South Sandy UT US 84070
30151802273015180227SUMMIT MEDICAL LLC1N2020-04-252945 Lone Oak Drive, Suite 160 Eagan MN US 55121

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1219041336832519K991670SILVERSTEIN MICROWICKETD1999-08-26
1068611065256950K99136330 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDUFRN1999-05-13
1219041001436748K982667MICROMEDICS NASAL SEPTAL BUTTONLFB1998-11-24
436171827827229K921450NON-INVASIVE TUBINGFPK1993-02-05
1219041667166113K911785RHINO-GUARDCAF1991-10-07
1219041283355114K854359LM2000A SURGICAL SUCTION MONITORKDQ1986-03-03
1219041214293818K832680MICRO-EDGE DISPOSABLE BLADESKDC1983-10-14
1219041014245372K830228OTOLOGICAL VENTILATION TUBES-VARIOUSETD1983-03-07
1219041738577851K210836InstruSafe Instrument Protection SystemKCT2021-11-30
2363521163949489K180528InstruSafe(R) Sterilization ContainerKCT2018-11-16
1219041163949489K180528InstruSafe(R) Sterilization ContainerKCT2018-11-16
1068611357658354K162165ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent PumpMEA2017-08-29
2363521459868801K151166Instru-Safe Instrument Protection SystemKCT2015-08-18
1219041459868801K151166Instru-Safe Instrument Protection SystemKCT2015-08-18
1219041740926789K150540Instru-Safe Instrument Protection SystemKCT2015-06-22
2363521740926789K150540Instru-Safe Instrument Protection SystemKCT2015-06-22
2363521131558715K142768Instru-Safe Instrument Protection SystemKCT2015-05-29
1219041131558715K142768Instru-Safe Instrument Protection SystemKCT2015-05-29
1219041035122406K142630Instru-Safe Instrument Protection SystemKCT2014-12-23
2363521035122406K142630Instru-Safe Instrument Protection SystemKCT2014-12-23
1219041962257268K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-12-15
2363521962257268K141513INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-12-15
1219041233223452K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-06-27
2363521233223452K140289INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-06-27
1219041072324845K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-03-13
2363521072324845K133015INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMKCT2014-03-13
1068611989272467K110814AMBIT TUNNELERBSO2011-04-08
1068611980857242K102460AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATHBSO2011-01-13
1219041990888119K092482TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500MUU2009-12-04
1219042033482137K092284LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200MUU2009-09-01
1219041451187400K081593POWER ASPIRATOR, MODEL LS2 OR LS2DPQPB2008-07-23
1219041163659671K073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000MJV2008-03-14
1068611773460339K052221AMBIT PUSH & PLAY AMBULATORY INFUSION PUMPFRN2005-12-08
1219041373427033K051157INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSKCT2005-09-01
2363521373427033K051157INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMSKCT2005-09-01
1068611455169108K033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMPFRN2003-11-06
1068611511208339K033325AMBIT CONTINUOUS AMBULATORY INFUSION PUMPFRN2003-11-06
1219041806597526K030300OPAQUE HERRICK LACRIMAL PLUGLZU2003-05-09
1068611394553184K024190FENESTRATED INFUSION CATHETERFRN2003-03-17
1219041455594127K012044BI-PHASIC INFILTRATORFRN2001-08-28
1068611363357237K002434PALM PUMPMEA2000-08-23
1068611319585570K001287EMPTY RESERVOIR BAG, 50 ML,100 ML,250 ML,500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 MLKPE2000-06-09
1219041132800350BK220688
1068611211229749
1068611445489263
1219041477514727
1068611820121749
1219041919247258
1068612001891222
1068612036816402
1219041098144664
1219041106979282
1219041123409797
1219041134558337
1219041160006847
1219041178742359
1219041180753662
1219041267170661
1219041277067206
1219041298350654
1219041311491362
1219041315937045
1219041413490670
1219041422710362
1219041447727475
1219041452542035
1219041464919978
1219041504315185
1219041513684274
1219041543292412
1219041554785219
1219041614225720
1219041653044085
1219041699855263
1219041715581827
1219041752563901
1219041846086790
1219041863910925
1219041941913485
1219041984809897
1219041995414084
1219041999004205

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KCT192021-11-30
FRN62005-12-08
MEA22017-08-29
BSO22011-04-08
MUU22009-12-04
ETD21999-08-26
KDQ21986-03-03
QPB12008-07-23
MJV12008-03-14
LZU12003-05-09
KPE12000-06-09
LFB11998-11-24
FPK11993-02-05
CAF11991-10-07
KDC11983-10-14

PMN#

GUDID#

200 records. Showing 1-40. Next