FDA.reportPublic FDA data

MICROTEK DOMINICANA, S.A.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80438173003094575MICROTEK DOMINICANA, S.A.1N2020-04-25ZONA FRANCA No. 2 LA ROMANA La Romana DO --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
148112027575748K980066CPR FILTERSHIELDBTM1998-07-16
148111696976035K953414CPR MICROMASK WITH OXYGEN INLETCBP1996-03-20
148111453035214K950770CPR MICROSHIELD IICBP1995-03-10
148112009633928K950769CPR MICROMASK PLUS CATALOG NO 73-402CBP1995-03-10
148111497838786K914702STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTSFXP1993-01-29
148111627908112K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYU1991-12-02
148111892800211K910941LIFELINER SURGICAL GLOVEFYE1991-05-09
148111199435394K900310REPEL SURGICAL GLOVE LINERSLYU1990-03-01
148111041394489K890917PHOENIX DRAPES WITH MICROBANKGX1989-08-17
148111078197607K882724MICROTEK PROBE DRAPEKKX1988-08-03
148111365596595K854613SURGICAL DRAPES, OPHTHALMINHMT1986-02-13
148111160307336K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASOJOP1984-08-23
148111133057859K142173NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPELHC2014-12-30
148111140729346K142080NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTEDLHC2014-08-28
148111661819487K132386TOTALSHIELD SURGICAL HELMET SYSTEMFYA2013-12-23
148111937312442K123108TVC IMAGING SYSTEM MODEL NIRS-MC7-70OGZ2013-03-15
148111817733071K110358VENODYNE V810JOW2011-05-05
148111078236401K091343MRI NEURO DRAPEKKX2009-09-22
148111281224933K090308RESTEP DVY SYSTEM, MODEL RSP-101JOW2009-05-01
148112040305607K070406ENDODRAPEKKX2007-07-30
148111521812253K052395STERILE EQUIPMENT COVERSKKX2005-12-01
148111142586968K051979ORS MODEL 6000 ENDOSCOPE HOLDEROCT2005-08-30
148111970189013K050776AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2005-06-06
148111927077926K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXT2005-06-17
148111469806045K023282ORS-3000LDLHC2002-11-13
148111120838343K003194STACKHOUSE LENS HOOD, MODEL SA-700/FSFYA2000-10-26
148112042596304K001802VENODYNE DVT ADVANTAGE MODEL 610JOW2001-01-09
148111071399048
148111140571741
148111156941589
148111158993029
148111214649626
148111222133313
148111397011255
148111601710499
148111688160701
148111721873459
148111729767254
148111781331645
148111813470568
148111948524973
148111964298064
148112050197679
148112062623284
148112065735083

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KKX42009-09-22
LHC32014-12-30
JOW32011-05-05
CBP31996-03-20
FYA22013-12-23
LYU21991-12-02
OGZ12013-03-15
OCT12005-08-30
DXT12005-06-17
LFL12005-06-06
BTM11998-07-16
FXP11993-01-29
FYE11991-05-09
KGX11989-08-17
HMT11986-02-13
JOP11984-08-23