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#

200 records. Showing 1-40. Next

PMN#

131 records. Showing 1-40. Next

Applications#

90 records. Showing 1-40. Next