FDA.report

Microtek Medical LLC

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30054256203005425620Microtek Medical LLC1N2026-01-012319 E Erwin St TYLER TX US 75702
30061164683006116468Microtek Medical B.V.1N2026-01-01HEKKEHORST 24 Zutphen Gelderland NL 7207 BN
30065810493006581049MICROTEK MEDICAL MALTA LIMITED1N2026-01-01SORBONNE CENTRE F20 MOSTA TECHNOPARK Mosta MT MST 3000
30103898343010389834Microtek Medical B.V. Varsseveld1N2026-01-01GESINKKAMPSTRAAT 19 VARSSEVELD Gelderland NL 7051 HR,
30134017493013401749Microtek Medical LLC1N2026-01-0113000 Deerfield Parkway, Suite 300 Alpharetta GA US 30004
30143426583014342658Microtek Medical LLC1N2026-01-013 Lakes Dr Northfield IL US 60093
30219708683021970868Microtek Medical LLC1N2026-01-01990 Lone Oak Road Suite 130 Eagan MN US 55121
10435821043582MICROTEK MEDICAL, INC.1N2020-04-25602 LEHMBERG RD. COLUMBUS MS US 39702
30054256203005425620MICROTEK MEDICAL, INC.1Y2020-04-252319 E Erwin St TYLER TX US 75702
30061164683006116468Microtek Medical B.V.1N2020-04-25HEKKEHORST 24 Zutphen Gelderland NL 7207 BN
30116998593000206154Microtek Medical, Inc.1Y2020-04-2513500 Tradeport Circle East Jacksonville FL US 32218
30134017493013401749Microtek Medical, Inc.1N2020-04-2513000 Deerfield Parkway, Suite 300 Alpharetta GA US 30004

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00748426264315Medline-Microtek - Patient Drape, Patient Isolation Drape, 244 cm x 330 cm (96 in x 130 in)1(800)633-5463customerservice@medline.com
10748426144577Medline-Microtek - C-ARM & MOBILE X-RAY DRAPE, 104 cm x 188 cm (41 in x 74 in)1(800)633-5463customerservice@medline.com
10748426144638Medline-Microtek - BANDED BAG WITH RUBBERBAND AND TAPE, 38 cm x 38 cm (15 in x 15 in)1(800)633-5463customerservice@medline.com
10748426144645Medline-Microtek - C-ARM DRAPE FOR FLUOROSCAN, 104 cm x 149 cm (41 in x 59 in)1(800)633-5463customerservice@medline.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3333801169448680K990912MTP EXTRACTION BAGGCJ1999-06-09
1621671385638832K990912MTP EXTRACTION BAGGCJ1999-06-09
148061933049576K980915VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEMFYD1998-06-29
3333801795763841K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERSITX1995-02-23
1621671859314413K921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERSITX1995-02-23
3333871185443267K914077REPEL(TM) LITE CUT RESISTANT GLOVE LINERSLYU1991-12-02
148061042256264K910515FREEDOM MARK III SURGICAL HELMET SYSTEMFYA1991-05-06
2018021041394489K890917PHOENIX DRAPES WITH MICROBANKGX1989-08-17
2018021078197607K882724MICROTEK PROBE DRAPEKKX1988-08-03
148062001945766K874512MODIFIED BIOVAC:LFA LASER FUME EVACUATION SYSTEMFYD1988-01-27
1621671160307336K843262TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASOJOP1984-08-23
3319091566163434K811269GLASS VIALSKPE1981-06-16
3333871566163434K811269GLASS VIALSKPE1981-06-16
148062063357705K811269GLASS VIALSKPE1981-06-16
3319091264459990K811268BOTTLE-TO-BOTTLEKPE1981-06-18
3333871264459990K811268BOTTLE-TO-BOTTLEKPE1981-06-18
148061848702867K811268BOTTLE-TO-BOTTLEKPE1981-06-18
148061433822603K811234I.V. BOTTLE (RIDGID)KPE1981-06-18
3319092004281293K811234I.V. BOTTLE (RIDGID)KPE1981-06-18
3333872004281293K811234I.V. BOTTLE (RIDGID)KPE1981-06-18
148061290587465K811233I.V. PLASTIC BAGKPE1981-06-17
3319092047761750K811233I.V. PLASTIC BAGKPE1981-06-17
3333872047761750K811233I.V. PLASTIC BAGKPE1981-06-17
3334051570214792K802146AQUASONIC 100 ULTRASOUND TRANS. GEL,IYO1980-10-10
3319091353436635K251676Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)LHI2025-09-16
3333931198341828K201290Medline DeNovo 4Pro Electrical Stimulation DeviceIPF2020-09-21
1839881339972275K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower WandNHV2019-03-29
1839881002510073K173164Ecolab POU Water FilterNHV2018-06-29
2018021961052744K150190IntraTemp Solution WarmerLHC2015-02-26
2018021133057859K142173NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPELHC2014-12-30
2018021140729346K142080NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTEDLHC2014-08-28
148061817733071K110358VENODYNE V810JOW2011-05-05
148061500336025K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STKFYA2011-02-23
3319091457422638K090308RESTEP DVY SYSTEM, MODEL RSP-101JOW2009-05-01
2018021657006074K083417INTRATEMP SOLUTION WARMERLHC2009-01-13
148061537535014K080291INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZERNAY2008-03-19
3333871657645756K050776AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEMLFL2005-06-06
148061734919876K050369INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000NAY2005-04-29
2018021700420164K0232831075LD HUSH-SLUSHLHC2002-11-13
2018021469806045K023282ORS-3000LDLHC2002-11-13
2018021858276410K021289WARMER 2000LDLHC2002-06-26
3319091167086813K011318VENODYNE DVT ADVANTAGE PLUSJOW2001-10-25
148061462867704K011318VENODYNE DVT ADVANTAGE PLUSJOW2001-10-25
148062042596304K001802VENODYNE DVT ADVANTAGE MODEL 610JOW2001-01-09
148061387602081K001082STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100FYD2000-06-15
148061071399048
148061140571741
1839881140571741
148061156941589
1839881156941589
2018021156941589
148061158993029
148061331208200
1839881384824702
148011688160701
1839881688160701
2018021688160701
148061708026870
148011813470568
1839881813470568
2018021813470568
2018021948524973
148061964298064
2018022065735083

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KPE121981-06-18
LHC72015-02-26
JOW52011-05-05
FYD32000-06-15
NHV22019-03-29
FYA22011-02-23
NAY22008-03-19
GCJ21999-06-09
ITX21995-02-23
LHI12025-09-16
IPF12020-09-21
LFL12005-06-06
LYU11991-12-02
KGX11989-08-17
KKX11988-08-03
JOP11984-08-23
IYO11980-10-10

PMN

GUDID

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