FDA.reportPublic FDA data

KELCO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80436313009638066Kelly Connor1N2026-01-01319 E Jenkins Ave. Columbus OH US 43207
96166923002226076Kela Veshi1N2026-01-0111403 Empire ln Rockville MD US 20852
30037338743003733874Kelly Nashawaty1N2026-01-0173 Princeton Street Suite 302 North Chelmsford MA US 01863
30065376993006537699KELLY GEYER-MEDINA1N2026-01-01312 Raleigh St Ste 9 Wilmington NC US 28412
30066504143006650414KELLER LABORATORIES1Y2026-01-01160 Larkin Williams Ind Ct Fenton MO US 63026
30085980383008598038Kela Veshi1N2026-01-017549 Spring Lake Dr Apt C2 Bethesda MD US 20817
30094247963009424796KELYNIAM GLOBAL INC.1N2026-01-0197 RIVER RD STE A COLLINSVILLE CT US 06019
30104622743010462274Kelly Kim1N2026-01-0125401 Cabot Rd Ste 122 Laguna Hills CA US 92653
30108751093010875109Kelly Giles1N2026-01-013470 McPherson Saint Louis MO US 63108
30151935273015193527KELLIDA INC1N2026-01-014035 Whitewater Creek Rd Nw Atlanta GA US 30327
30152523493015252349Kelvi1N2026-01-01413 N Oak Street Inglewood CA US 90302
30214870943021487094KELCOR, LLC1N2026-01-011348 Falmouth Rd Chattanooga TN US 37405
30396419233039641923KELSEY DENTAL LLC1Y2026-01-0132222 Tamina Rd Ste 5-09a The Woodlands TX US 77354
30447364023044736402Kelfred Optical (Thailand) Co., Ltd.1N2026-01-01111 Moo 15, Theparak road Bang Sao Thong Sub-district Bang Sao Thong District Samut Prakan TH 10570
00Kelvin Gao5N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
00Kelvin Gao5N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
00Kelvin Gao5N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
00Kelvin Gao5N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
00Kelvin Gao5N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
30010755863001075586KELLY BAGLA1N2020-04-255857 OWENS AVE STE 300 Carlsbad CA US 92008
30166373283016637328KELL ELECTRONIC USA1Y2020-04-251300 Bay Area Blvd 8150-38 Houston TX US 77062
30166907573016690757Kelvin Gao1N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755
30167105453016710545Kelvin Gao1N2020-04-251846 E. INNOVATION PARK DR., STE 100, ORO VALLEY , AZ 85755 Oro Valley AZ US 85755

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860009651609KC Airway Taping System - Adult Airway Tape and Eye Tape - Short-term901-300-6125info@kelcortape.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1300771861083359K983887UP-GRADE AND UP-GRADE PROFLL1999-02-12
1300771774257106K970211MICROLIFE AUTOMATIC BLOOD PRESSURE MONITORDPW1998-04-30
1300771775294693K970139MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIODPW1998-04-30
125741509269126K913416TETLEY PATIENT ADMINISTRATION SETIYT1991-10-28
1879321780004250K251414Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)NEW2025-10-20
2076891730748902K250334Fusion Craniofacial Implant; Fusion Skull ImplantGWO2025-07-25
1879321772214358K250107V-soft Line™ Barbed Surgical Suture (Various)NEW2025-10-15
1300771854151461K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2023-08-25
1879321076917645K213010FEELject LDV (Low dead volume) syringeQNQ2023-05-31
125741892639271K200916Patient Administration SetIYT2020-09-01
1300771145083755K200802Infrared ThermometerFLL2020-10-07
2076891396110013K182711Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO2019-05-21
1300771810734217K182629Digital ThermometerFLL2019-02-28
1879321094480068K172602MiracuNEW2018-11-14
1300771919897544K163648Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic Blood Pressure Monitor BPM45 SeriesDXN2017-07-07
1300771623919515K163518Digital ThermometerFLL2017-09-19
2017661611140141K162629IQM Integral Quality Monitor (also IQM)IYE2016-10-20
1300771858753978K160019U80 Series Upper Arm Electronic Blood Pressure MonitorDXN2016-04-22
1300771006028004K141924HD BLOOD PRESSURE MONITORDXN2014-09-08
1660211209333077K133390NDX DORSAL APPLIANCELRK2014-10-16
1300771542978596K122810COMPACT DIGITAL BLOOD PRESSURE MONITORDXN2013-02-08
2076891082731479K121755CUSTOM CRANIOFACIAL IMPLANT (CCI)GXN2012-09-25
569041270607705K111246SPIRALE DRUG DELIVERY SYSTEMCAF2012-08-10
2076891370407490K103582KELYNIAM CUSTOM SKULL IMPLANT (CSI)GXN2011-04-14
1300771950175679K103407COTRONIC DIGITAL THERMOMETERFLL2011-05-13
1300771434888764K101253RII INFRARED EAR THERMOMETER, MODEL: TH60NFLL2010-06-29
1879321053749852K092831DISPOSABLE HYPODERMIC NEEDLEFMI2010-01-14
149891080192238K071984MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEMGWM2008-06-27
1300771053458856K061471MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MC1-PCDXN2006-09-11
1300771341565509K051269RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIESFLL2005-09-09
1300771487783892K050083BLOOD-PRESSURE METER, BPW120DXN2005-04-08
1300772030336931K040723MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)BZH2004-06-10
3420731065576975K032498DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)NHA2003-08-27
1300771822350716K032434CLINICAL ELECTRONIC THERMOMETERFLL2004-12-27
1300771958973130K032362UP-GRADE FOREHEAD THERMOMETERFLL2003-12-04
149891105257638K020285CMA CEREBRAL TISSUE MONITORING SYSTEMGWM2002-10-23
1300771185380411K013485MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTIONAL THERMAL PRINTER, MODEL PR 1KA1DXN2002-01-17
1660211134411669K010876NTI TENSION SUPPRESSION SYSTEMOCO2001-06-20
2116931484060327DEN130047PROLONGPIA2015-03-20
1300771020272183
1300771036771203
2536031055302764
2536031110277498
2432321209067695
2431861229078584
1356741276215141
1300771281370931
2536031323326811
2563101389389875
2437951455100385
1300771467035362
1879321487696987
1300771497533305
1356741510920355
1300771511595267
1300771535426446
1660211548284917
1300771601173224
2205821690544290
2536031714736524
1300771721683536
1300771731829565
2531881779486384
1300771803409393
569041811637109
1300771837345083
2536031891595222
2268021969681683
1660211972815384
2517391991307205
1660211994150008
1660212071453800
1300771006081126
1300771037483887
3420731074443071
1300771080335635
1660211082500748
569041175793601
569041176549065
1300771189716283
1300771250983823
1300771252622875
1300771274824616
1300771282422325
3420731308087938
1300771319919668
3420731325391658
3495221332299312
1300771353761421
1300771357695561
1300771376363779
1660211459931564
1300771465816561
3495221477050474
1300771530310605
3012771551317570
1300771553625606
3495221575532656
1300771601884764
3495221621868134
1879321643406924
1300771659593058
1300771689650593
1300771696710055
1300771730154258
3012771748334552
1300771748739320
149891751094958
1300771797489803
1300771801774228
1300771806150252
3420731806259756
1300771809769464
149891838091847

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN92023-08-25
FLL92020-10-07
NEW32025-10-20
GWO22025-07-25
IYT22020-09-01
GXN22012-09-25
GWM22008-06-27
DPW21998-04-30
QNQ12023-05-31
IYE12016-10-20
PIA12015-03-20
LRK12014-10-16
CAF12012-08-10
FMI12010-01-14
BZH12004-06-10
NHA12003-08-27
OCO12001-06-20

NDC#

PMA#

PMN#

PALMA

1988-11-25

KELSO IMPORTS

SAY

1983-01-07

KELLS MEDICAL, INC.

128 records. Showing 1-40. Next

GUDID#