FDA.reportPublic FDA data

LEO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96135583003215851LEONEL MARTINEZ Leonel Martinez, Jr.1N2026-01-0110 Finegan Rd DEL RIO TX US 78840
96174883003741742Leon Tseng1N2026-01-011509 NW 82nd Ave. Doral FL US 33126
30015619233001561923LEONE SPA1N2026-01-0150, VIA P. A QUARACCHI Sesto Fiorentino Firenze IT I-50019
30041814783004181478Leonard Rollins1N2026-01-011815 14th St. NW Suite D Rochester MN US 55901
30055956873005595687LEONHARDT MANUFACTURING CO, INC.1N2026-01-01800 High Street Hanover PA US 17331
30094924093009492409Leo Chan1N2026-01-01815 Oakwood Road, Unit I Lake Zurich IL US 60047
30100928183010092818Leonard Krause1N2026-01-01353 Mary Ln Eugene OR US 97405
30113473003011347300LEO MEDICAL CO., LTD.1N2026-01-01No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA Changzhou Jiangsu CN 213022
30134260403013426040LEONEAMERICA DENTAL PRODUCTS, INC.1Y2026-01-011400 GRAVES AVE UNIT A Oxnard CA US 93030
30175000613017500061LEO CANCER CARE INCORPORATED1N2026-01-017921 UW Health Court Middleton WI US 53562
30226330753022633075Leo Cancer Care Ltd.1N2026-01-01Arrow Point Unit 2 Churchill Court; Manor Royal Crawley West Sussex GB RH10 9BT
30299442863029944286Leona Liu1N2026-01-01202 Canal Street, Suite 303 New York NY US 10013
30436574203043657420Leona Liu1N2026-01-01202 Canal Street, Suite 303 New York NY US 10013
00LEO5N2020-04-251384 Broadway,Suite 1206 New York NY US 10018
10004791821000479182LEONARD A. FEINBERG INC.1Y2020-04-251824 Byberry Road Bensalem PA US 19020
30073363853007336385LEONI Fiber Optics Inc.1N2020-04-25209 Bulifants Blvd Williamsburg VA US 23188
30113570223011357022Leonard Leibman1N2020-04-253 Dutch Court Sinking Spring PA US 19608

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2208352042240876K9730363M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRESMGP1997-11-12
2208351117242714K960653MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)GAN1996-03-28
2208351844016000K952861ANGIOCATH & INSYTE AUTOGUARD CATHETERSFOZ1995-07-31
2795201353025133K250970MarieJAK2025-07-25
3369311446233164K241888Single-use Balloon Dilatation CatheterFGE2024-12-20
228021594355162K220016Viramed Borrela All-In-One ViraChip Test KitLSR2022-08-19
3369311158773842K172985Ligation DeviceFHN2018-06-14
228021946955117K163695Borrelia B31 ViraChip IgM Test KitLSR2017-08-22
228021488619405K163504Borrelia B31 ViraChip IgG Test KitLSR2017-07-12
2208351389636657K121607TERUMO(R) NEEDLEFMI2012-11-08
2208351789337431K121275AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBERFRO2012-07-25
228021061851144K092693VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUSLSR2009-11-25
209601493635360K091702CDB FLIP-SIDE-CLIP BRACKETNJM2009-08-07
228021181537207K082329VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPELSR2009-08-05
209601287187715K071490LEONE ORTHODONTIC MINI IMPLANTOAT2008-02-22
209601793767070K060732MBCP GELLYC2006-06-02
228021632030078K051169BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOTLSR2005-08-11
228021057274864K051071VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOTLSR2005-08-11
1246072005811954K050738FT FIBER OPTIC DELIVERY SYSTEMSGEX2005-06-02
209601283042704K050586LEONE IMPLANT SYSTEMDZE2006-02-27
2208351170143873K023271TERUMO SYRINGE WITH/WITHOUT NEEDLEFMF2002-12-18
1711841041492985
209601053530159
324221175371691
2465501775984680
209601846861430
1711841903760002
2465501954720015
1711841052276210
324221077553843
324221078633709
3475711111188552
209601139075110
209601148465640
324221183807895
3440741229788981
324221262883535
209601306649028
228021335058185
1711841371601662
209601379572609
3365031384219081
209601392555067
3275591395720745
324221409269814
324221414953857
209601431614523
324221437228225
209601442369075
209601458943159
3244301475693118
2795201475693118
3365031492955338
209601494128893
209601505379498
209601511644276
324221547463358
324221549026160
209601594415513
209601612683062
3275591622967554
3275591641386803
209601677256891
209601681545660
3440741697654200
209601699923837
209601767274951
3275591791762138
209601798365417
209601798767360
324221828220869
324221837486744
555581842243391
209601848680590
3275591878482515
209601880424094
228021906418082
324221956875271
3275592019760110
209602030480782
324222031710693
324222037976349
3275592044109966
324222047060186
324222048320589

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LSR72022-08-19
JAK12025-07-25
FGE12024-12-20
FHN12018-06-14
FMI12012-11-08
FRO12012-07-25
NJM12009-08-07
OAT12008-02-22
LYC12006-06-02
DZE12006-02-27
GEX12005-06-02
FMF12002-12-18
MGP11997-11-12
GAN11996-03-28
FOZ11995-07-31

NDC#

ENSTILAR

LEO Pharma Inc.

calcipotriene and betamethasone dipropionate

Adbry

LEO Pharma Inc.

tralokinumab-ldrm

Adbry

LEO Pharma Inc.

tralokinumab-ldrm

TACLONEX

LEO Pharma Inc.

calcipotriene and betamethasone dipropionate

CHOOZ

Leosons Overseas Corp.

Calcium Carbonate

Relief

Leosons Overseas Corp

SODIUM PHOSPHATE, MONOBASIC and SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE

Gas-Aid

Leosons Overseas Corp

simethicone

PMA#

PMN#

51 records. Showing 1-40. Next

Applications#