FDA.reportPublic FDA data

Ascensia Diabetes Care US Inc.

Matched from indexed company URL: ASC CORP.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18109091810909Ascensia Diabetes Care US Inc.1N2026-01-01100 Summit Lake Drive Valhalla NY US 10595
29549023003243726ASCEND EAGLE, INC.1Y2026-01-01828 San Pablo Avenue Pinole CA US 94564
30044851663004485166Asclepion Laser Technologies GmbH1N2026-01-01Bruesseler Str. 10 Jena Thuringia DE 07747
30086623553008662355Ascend Surgical Sales, LLC1Y2026-01-01574 Highland Colony Pkwy Ste 320L Ridgeland MS US 39157
30088551703008855170ASCOM US, INC.1Y2026-01-01300 Perimeter Park Dr Ste D Morrisville NC US 27560
30095955613009595561ASCENT CONSUMER PRODUCTS, INC.1N2026-01-01105 Baylis Rd Melville NY US 11747
30111217403010700165Ascensia Diabetes Care US Inc.1N2026-01-015 Wood Hollow Road Parsippany NJ US 07054
30112179653011217965ASCENSION TECHNOLOGY CORPORATION1Y2026-01-01120 Graham Way, Suite 130 Shelburne VT US 05482
30121186593012118659ASCENSIA DIABETES CARE HOLDINGS AG1N2026-01-01Peter Merian-Strasse 90 Basel Basel-Stadt CH CH-4052
30125908713012590871ASCEND EXCELLENCE DAILY PRODUCTS JIANGSU CO., LTD1N2026-01-01Room 1010, Block 1, Fengchuang Mansion, West of Runyang Rd & Sou Yangzhou Jiangsu CN 225009
30130695463013069546ASCENTRON, INC.1N2026-01-01994 Antelope Rd. White City OR US 97503
30142072833002788818Ascension Orthopedics, Inc.1N2026-01-0111101 Metric Blvd Austin TX US 78758
30151680973015168097ASCEND CARDIOVASCULAR LLC1N2026-01-012501 Chatham Rd STE 5053 Springfield IL US 62704
30151736343015173634ASCOM UMS SRL1N2026-01-01Via Amilcare Ponchielli 29 Scandicci Firenze IT 50018
30167987743016798774ASCENTCARE DENTAL PRODUCTS1N2026-01-01335 North Griffin Grand Haven MI US 49417
30342880493034288049ASCLEPIUS MEDICAL HOLDINGS LLC1Y2026-01-015160 Parfet St Unit A5 Wheat Ridge CO US 80033
30422705573042270557ASCLEPII INC.1Y2026-01-0111000 Cedar Ave Ste 101ak Cleveland OH US 44106
30430430173043043017ASCEND USA, LLC1Y2026-01-018312 38th St N Lake Elmo MN US 55042
30053345493005334549Ascom (US) Inc.1N2020-04-259024 Town Center Parkway Bradenton FL US 34202
30142072833002788818Ascension Orthopedics, Inc.1N2020-04-2511101 Metric Blvd Austin TX US 78758
30154177583015417758ASC MARKETING LTD.1Y2020-04-257615 Othello Ave. Suite H-I San Diego CA US 92111

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1912631534525097P160017MiniMed 670G SystemOZP2016-09-28
1928481534525097P160017MiniMed 670G SystemOZP2016-09-28
2544691534525097P160017MiniMed 670G SystemOZP2016-09-28
1912631492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
1928481492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
2544691492555049P150001MINIMED 630G SYSTEM WITH SMARTGUARD(TM)OZO2016-08-10
2898961169152067P000057ASCENSION MCPNEG2001-11-19
2135571965663980P000057ASCENSION MCPNEG2001-11-19
2898961703509773K991873KMI WRIST FUSION SYSTEMHRS1999-08-17
2135571403741746K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
2898961906776820K981194FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANTKWH1998-06-30
2898961889910595K960692SUBTALAR MBA SYSTEMHWC1996-07-23
1912631056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
1928481056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
2544691056493549K831600DIASTIX REAGENT STRIPS FOR URINALYSISJIL1983-09-08
1912631337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
1928481337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
2544691337358993K801270TEST FOR KETONE IN URINE(ACETOACETIC ACJIN1980-07-08
764431387227415K261094YellowStarGEX2026-04-29
764431098161542K253100MultiPulse TFLGEX2025-10-23
1912631998431943K241810MICROLET®NEXT LancetQRK2024-08-15
1928481998431943K241810MICROLET®NEXT LancetQRK2024-08-15
2544691998431943K241810MICROLET®NEXT LancetQRK2024-08-15
1912631724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
1928481724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
2544691724761781K241787CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2024-08-27
764431063616102K241600DermablateGEX2024-07-03
764431475565954K240831MultiCut SoloGCJ2024-11-06
764431733696706K240816MeDioStarGEX2024-04-23
2898961131537267K233674Freedom Wrist Arthroplasty SystemJWJ2024-05-30
2898961033450678K233670Ascension Silicone MCP; Ascension Silicone PIPKYJ2023-12-14
764431054862596K231876MultiPulse HoPLUSGEX2024-02-22
1912631129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
1928481129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
2544691129702752K231679CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW2024-02-23
1912631147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
1928481147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
2544691147758777K223293CONTOUR® NEXT GEN Blood Glucose Monitoring SystemNBW2022-11-18
1912631067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
1928481067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
2544691067755245K220633MICROLET NEXT lancing device, MICROLET LancetQRL2022-06-03
764431575799446K213889PicoStarGEX2022-04-22
2898961026132831K213827TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst)KWS2022-03-11
1912631214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
1928481214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
2544691214897858K210687CONTOUR® NEXT ONE Blood Glucose Monitoring SystemNBW2021-08-11
764432064753463K210634MCL 31 Dermablate SystemGEX2022-04-13
2898961758621374K210016Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS SystemHRS2021-07-27
2898961478604026K201507Cadence Total Ankle SystemHSN2020-06-29
1912631598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
1928481598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
2544691598915488K193407Contour® next GEN Blood Glucose Monitoring SystemNBW2021-12-23
764431207196349K192483MeDioStarGEX2020-03-13
2269991197052712K192372ASCEND Image ViewerLLZ2020-02-14
764431087097173K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEX2019-09-17
1912631950158680K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
1928481950158680K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
2544691950158680K191286CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring SystemNBW2019-11-08
2898961186706365K190588Integra TITAN Reverse Shoulder SystemPHX2019-12-02
2135571272811306K190588Integra TITAN Reverse Shoulder SystemPHX2019-12-02
2898961026726090K182878Integra Salto Total Ankle SystemHSN2018-12-18
2135571242311796K182878Integra Salto Total Ankle SystemHSN2018-12-18
2898961493285743K181999Integra TITAN Reverse Shoulder SystemPHX2018-10-12
2135571619888422K181999Integra TITAN Reverse Shoulder SystemPHX2018-10-12
764431157274659K181867Deka Smartxide2 TrioGEX2018-10-02
2898961714795152K181639Panta 2 Arthrodesis Nail SystemHSB2018-11-02
2135571808008842K181639Panta 2 Arthrodesis Nail SystemHSB2018-11-02
2368311132536333K180566Unite Connect for Clinical SystemsMSX2018-04-03
2368311014015252K180430Digistat Smart CentralMSX2018-11-23
2256031270948270K180430Digistat Smart CentralMSX2018-11-23
2898961736726425K173717Integra TITAN Reverse Shoulder SystemPHX2018-06-21
2135572024976445K173717Integra TITAN Reverse Shoulder SystemPHX2018-06-21
764431075765446K163449HyPHo Laser SystemGEX2017-06-23
1912631958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
1928481958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2544691958727235K162336Contour Next EZ Blood Glucose Monitoring SystemNBW2017-01-12
2135571483429082K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemHWC2017-07-14
2898961908485026K162153Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation SystemHWC2017-07-14
764431801529816K161257MultiPulse HoPLUSGEX2017-03-31
2898961349538241K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
2135571585985245K161189Integra TITAN Reverse Shoulder SystemPHX2016-08-25
2135571681628782K160830Integra External Fixation SystemKTT2016-07-06
1912631302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
1928481302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
2544691302816265K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemNBW2016-11-17
1912631446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
1928481446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
2544691446117500K160430Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring SystemNBW2016-06-24
2135571928321842K153452Salto XT, Salto TalarisHSN2016-08-11
2898962034076051K153452Salto XT, Salto TalarisHSN2016-08-11
2135571456028240K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC2015-10-29
2898961486026197K152527Integra DigiFuse Cannulated Intramedullary Fusion SystemHWC2015-10-29
764431825069442K152153MicroSpot HandpieceGEX2015-12-11
2135571848949964K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS2015-12-23
2898962007606994K152047INTEGRA TITAN Modular Total Shoulder System Fin-Lock GlenoidKWS2015-12-23
1912631700819276K151742Contour Next Control SolutionJJX2015-09-23
1928481700819276K151742Contour Next Control SolutionJJX2015-09-23
2544691700819276K151742Contour Next Control SolutionJJX2015-09-23
2135571697995180K151459Integra Total Ankle Replacement SystemHSN2015-08-31
2898961789344703K151459Integra Total Ankle Replacement SystemHSN2015-08-31
764431749953765K150140MCL 31 DermablateGEX2015-06-05
764431622499396K143519The MeDioStar NeXT FamilyGEX2015-03-10
2898961651855583K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
2135571865193679K142413TITAN Modular Total Shoulder SystemKWS2014-11-14
2135571982722991K140463INTEGRA EXTERNAL FIXATION SYSTEMKTT2014-10-10
764431013192635K133891MULTIPULSE TM+1470GEX2015-01-30
764431554180845K133297QUADROSTARPROGREEN, QUADROSTARPROYELLOWGEX2014-06-10
2898961895283587K132250INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEMJWJ2014-03-24
764431387285377K131987MULTIPULSE HOPLUSGEX2014-10-15
764432042770161K131757TATTOOSTAR EFFECT COMBOGEX2014-07-17
2135571795845811K131360INTEGRA TITANIUM BONE WEDGEHRS2013-08-07
2135572041718596K130533SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSHSN2013-05-17
2898962049422236K130533SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHSHSN2013-05-17
1912631211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
1928481211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
2544691211802849K130265CONTOUR NEXT EZ BLOOD GLUCOSE METERNBW2014-06-23
2898961372522585K130050TITAN REVERSE SHOULDER SYSTEMKWS2013-06-18
2135572048917324K130050TITAN REVERSE SHOULDER SYSTEMKWS2013-06-18
2135571771705513K123926METASURG NITINOL STAPLE IMPLANTJDR2013-05-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NBW452024-08-27
GEX212026-04-29
HWC162017-07-14
HRS152021-07-27
HSN132020-06-29
KWS112022-03-11
LFR92012-07-26
PHX82019-12-02
KWH82003-01-17
KYJ52023-12-14
MSX52018-11-23
KYI52011-11-04
KWD52010-01-14
KXE42012-04-09
HSD42007-06-22
QRK32024-08-15
JWJ32024-05-30
QRL32022-06-03
OZP32016-09-28
OZO32016-08-10
JJX32015-09-23
KWI32004-04-16
JIL31983-09-08
JIN31980-07-08
HSB22018-11-02
KTT22016-07-06
JDR22013-05-03
LZJ22010-12-21
LZA22010-10-15
KWN22008-06-17
NEG22001-11-19
GCJ12024-11-06
LLZ12020-02-14
LYY12006-01-25

NDC#

AndroGel

ASCEND Therapeutics U.S., LLC

Testosterone

AndroGel

ASCEND Therapeutics U.S., LLC

Testosterone

AndroGel

ASCEND Therapeutics U.S., LLC

Testosterone

AndroGel

ASCEND Therapeutics U.S., LLC

Testosterone

EstroGel

ASCEND Therapeutics US, LLC

estradiol

SinuCleanse

ASCENT CONSUMER PRODUCTS, INC.

SODIUM BICARBONATE, SODIUM CHLORIDE

SinuCleanse

ASCENT CONSUMER PRODUCTS, INC.

SODIUM BICARBONATE, SODIUM CHLORIDE

SinuCleanse

ASCENT CONSUMER PRODUCTS, INC.

SODIUM BICARBONATE, SODIUM CHLORIDE

Zilactin

ASCENT CONSUMER PRODUCTS, INC

benzyl alcohol

Oxygen

Ascension Via Christi Home Medical Wichita, LLC

Oxygen

200 records. Showing 1-40. Next

PMN#

Dermablate

2024-07-03

Asclepion Laser Technologies GmbH

MeDioStar

2024-04-23

Asclepion Laser Technologies GmbH

PicoStar

2022-04-22

Asclepion Laser Technologies GmbH

MeDioStar

2020-03-13

ASCLEPION LASER TECHNOLOGIES GMBH

131 records. Showing 1-40. Next

Applications#

220025

ASCENT PHARMACEUTICALS INC.

218722

ASCEND LABORATORIES, LTD

213613

ASCEND LABORATORIES, LTD

90 records. Showing 1-40. Next