FDA.reportPublic FDA data

Delta

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10518201051820DELTA MEDICAL SYSTEMS, INC.1Y2026-01-011325 Calvary Creek Parkway,SW Gainesville GA US 30507
14224091000143841DELTA TRADING CO OF AMERICA1Y2026-01-01472 Mount Ct NORTH AURORA IL US 60542
17211833001239292DELTA HI-TECH, INC.1Y2026-01-018695 Seward Road Fairfield OH US 45011
25288962528896DELTA MEDICAL SUPPLY GROUP, INC.1Y2026-01-0118 Chestnut Street Pomeroy PA US 19367
10001721271000172127DELTA S.R.L.1N2026-01-01Via Dell'Occhiale 11 DOMEGGE Di CADORE Belluno IT 32040
30027895263002789526DELTAMED GMBH1N2026-01-01RAIFFEISENSTR. 8a FRIEDBERG Hesse DE D-61169
30049677673004967767DELTA MED SPA1N2026-01-01Strada Provinciale per Dubino 10 Delebio Sondrio IT 23014
30072571233007257123DELTA BRANDS INC.1Y2026-01-01580 White Plains Rd Ste 600 Tarrytown NY US 10591
30124409483012440948DELTA INTERNATIONAL SERVICE & LOGISTICS S.R.L.1N2026-01-01Piazza Adriana 4 Roma IT 00193
30176679163017667916DELTA DEVELOPMENT TEAM INC1N2026-01-011635 S. Research Loop Suite 303 Tucson AZ US 85710
30244918943024491894DELTA MOLDING LLC1N2026-01-011237 East Beamer St, STE G Woodland CA US 95776
00DELTA SUPPLY & SERVICES, LLC5Y2020-04-2536075 Parkhurst Ave Livonia MI US 48154
96169843003188686DELTAI MEDICAL & HEALTH ARTICLES (SUZHOU) CO., LTD1N2020-04-25No. 88 Fuda Road, Ludu Town, Taicang, Suzhou Taicang Jiangsu CN 215400
10002505531000250553DELTA ELECTRONICS INC.1N2020-04-253 Tungyuan Road Chungli Industrial Zone Taoyuan TW 32063
30056092093005609209DELTA SURGICAL INSTRUMENTS, INC.1Y2020-04-2595 SCHUNNEMUNK RD. HIGHLAND MILLS NY US 10930
30077675093001130630DELTA AIR LINES, INC.1Y2020-04-251030 Delta Blvd Atlanta GA US 30354
30105209243010520924DELTA MED NORTH AMERICA INC1Y2020-04-25350 5th AVE FL 41 New York NY US 10118
30116709483011670948DELTA GALIL USA INC.1Y2020-04-251 HARMON PLZ FL 5 Secaucus NJ US 07094
30166924593016692459DELTAMED SUPPLY1Y2020-04-25111 OAKHURST DR Clinton MS US 39056

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
164811029474182K993659RENAMEL PACKEBF2000-01-18
164812045748907K980800LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBF1998-11-09
164811481504884K980799HIGH VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIALEBG1998-10-28
164811138946697K980298FLOWABLE HYBRIDEBD1998-03-09
164811216327773K974494RENAMEL FLOWABLE COMPOSITEEBD1998-02-10
164811401233868K921820RENAMEL ESTHETIC RESTORATIVE SYSTEM, MODIFICATIONEBF1992-06-16
164811763965165K894477INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEMEMA1990-01-10
164811876916298K873356INSURE PORCELAIN VENEER BONDING SYSTEMEMA1987-12-29
164811426083801K862912RENAMELIZE POLISHING PASTEEJR1986-08-12
164811974423999K854755RENAMEL ESTHETIC RESTORATIVE SYSTEMEBF1986-03-13
164811195788022K2437203Delta UNlimitedEBF2024-12-18
164811770094624K240714Insure® Universal; Insure® Universal AutomixEMA2024-07-24
164811195115784K230341ACRIFIXEBI2023-04-06
164811605058519K222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF2022-10-11
164811487031068K2125413Delta Denture Base - 3Delta Denture Bond - 3Delta Denture FixEBI2022-01-10
164811322517816K2118043Delta CrownEBF2021-12-06
164811247882162K211259Renamel BulkfillEBF2021-06-24
1873361560498680K201458Scrambler Therapy Technology (Model ST-5A)GZJ2020-12-23
164811093177318K200039P pro Crown & BridgeEBG2020-07-31
329971659391765K181447Safety insulin needle for single useFMI2019-03-12
164811401320358K172707Renamel MicrofillEBF2017-12-05
329971183478960K163578EasyTouch Safety Pen NeedleFMI2018-08-03
164811244552126K163480Renamel NANO +plusEBF2017-02-24
1873361140437703K142666Scrambler Therapy MC-5 A DeviceGZJ2015-05-22
2305211646803494K133892IVUE 500HLI2014-03-19
329971467318700K112789EASY TOUCHFMI2011-12-23
164811003800247K102776EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEMEBG2011-02-18
329971418559857K102178EASY TOUCHFMF2010-09-02
164811897026672K092730COSMEDENT BRUSHABLE COMPOSITEEBF2009-11-20
329971659345301K091474EASY.TOUCH INSULIN SYRINGEFMF2009-07-09
164811314719726K070583NANO COMPOSITEEBF2007-04-16
663191336190817K060654DSI PINS AND WIRESHTY2006-04-28
164811379121155K052501MULTIPLE RESIN TOOTH BONDING AGENTKLE2005-10-21
164811052891778K042823COSMEDENT PIT & FISSURE SEALANTEBC2004-12-01
164811522577897K040994COSMEDENT CORE PASTEEBF2004-06-03
164811569060232K030832PRIMOSPLINT SYSTEMMQC2003-09-17
164811025064013K011239GINDA GUARDEBD2002-02-14
663191045869254
164341047412639
663191063504747
164341072074395
663191078011802
663191086379848
663191096027181
663191129142773
164341130133108
236991147452482
663191151752980
164341161034067
663191163757985
164341170791193
164341186075171
164341210168739
164341211735133
663191216007727
663191244069990
236991270463627
663191279887867
164341287057243
164341301551771
164341312857628
164341320121800
663191340173635
164341340184884
164341345415882
164341389958793
164341406428597
663191411317640
164341416289029
663191426296495
164341454256593
164341478521725
164341499770566
164341504546660
164341524847790
164341534847750
164341550809528
663191575373263
663191596208801
663191620187822
164341620216606
663191659826667
663191688038455
164341689443834
663191690696878
164341699455646
164341730476153
663191745842872
164341776757941
663191785178851
164341790977163
164341800611947
663191806469044
164341822846665
236991828676019
164341835165195
663191847269135
164341869205078
663191914498741
663191914533497
164341917213292
663191919108744
663191920861426
236991930060459
164341941361026
164341951939134
164341957750019
663191994739153
164341997917193
164342015417837
164342042178016
165631030085757
165631315526324
329971358715327
3096491564627784
164811574870014
164811654426222
329971760099166
236991763261208

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EBF132024-12-18
EMA32024-07-24
EBG32020-07-31
FMI32019-03-12
EBD32002-02-14
EBI22023-04-06
GZJ22020-12-23
FMF22010-09-02
HLI12014-03-19
HTY12006-04-28
KLE12005-10-21
EBC12004-12-01
MQC12003-09-17
EJR11986-08-12

NDC#

Chestrub

Delta Brands Inc

Camphor Menthol Eucalyptus Oil

PMN#

SH-1

1977-05-09

DELTA MEDICAL INDUSTRIES

48 records. Showing 41-48. Previous

GUDID#

Lucky Super Soft - First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

DELTA BRANDS INC.

2026-04-10

Lucky Super Soft - First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

DELTA BRANDS INC.

2026-03-27

Lucky Super Soft - First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

DELTA BRANDS INC.

2026-02-13

Lucky Super Soft - First Aid Bandages Wihout Drug (With no drug, Adhesive bandages in a variety of different sizes and shapes )Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

DELTA BRANDS INC.

2025-07-09

80 records. Showing 1-40. Next