FDA.reportPublic FDA data

BioSkin LLC

Matched from indexed company URL: BIOS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20242353000210483BioSkin LLC1N2026-01-01240 E Hersey St Ste 2 ASHLAND OR US 97520
20270622027062BIOSEAL1N2026-01-01167 WEST ORANGETHORPE AVE. PLACENTIA CA US 92870
20854021000519735BIOSYS LABORATORIES, INC.1Y2026-01-01526 Mission Street S Pasadena CA US 91030
22425472242547BIOSEARCH MEDICAL PRODUCTS, INC.1N2026-01-014715 CORPORATE DR. NW SUITE 200 Concord NC US 28027
96157283002808761BIOSPHERE MEDICAL, S.A.1N2026-01-01Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile 95700 ROISSY-EN-FRANCE, FRANCE Roissy Val-d'Oise FR 95700
96732413003248396BIOSENSE WEBSTER, INC.1N2026-01-01CIRCUITO INTERIOR NORTE, No. 1820 PARQUE INDUSTRIAL SALVARCAR JUAREZ Chihuahua MX 32574
10005607721000560772BIOSCULPTOR CORPORATION1N2026-01-012480 W 82nd St Unit 1 Hialeah FL US 33016
30029454993002945499BIOSIGMA SPA1N2026-01-01Via Valletta, 6 Cantarana di Cona (VE) Veneto IT 30010
30031939333003193933BIOSPACE INC.1Y2026-01-0113850 CERRITOS CORPORATE DR STE C Cerritos CA US 90703
30082030033008203003Biosense Webster (Israel), Ltd.1N2026-01-014 Hatnufa Street Yokneam Northern IL 2066717
30103317703010331770BIOSENSICS1N2026-01-0157 Chapel Street, Suite 200 Newton MA US 02458
30108722903010872290Biosonic Technologies, LLC1N2026-01-016370 Annie Oakley Drive Las Vegas NV US 89120
30133000263013300026BIOSENSE WEBSTER, INC.1Y2026-01-0131 Technology Drive, Suite 200 -- Irvine CA US 92618
30140277383014027738BIOSERENITY MEDICAL DEVICES GROUP1N2026-01-016/8 rue Jean Antoine de Baif PARIS CEDEX 13 Ile-de-France FR 75013
30146543603014654360BIOSAFE SUPPLIES, LLC1N2026-01-01230 Sunport Ln Ste 100 Orlando FL US 32809
30160577993016057799BIOSCI INC.1Y2026-01-0123 Orchard Rd Ste 202 Skillman NJ US 08558
30181870173018187017BIOSYNCHRONICITY CORPORATION1N2026-01-01325 118th Avenue SE, Ste 210 Bellevue WA US 98005
30224510733022451073BIOSENSE WEBSTER, INC.1N2026-01-0123 Hubble Drive Irvine CA US 92618
30272418283027241828BIOSERVO AB1N2026-01-01Torshamnsgatan 35 Kista Stockholm SE 16440
30299062263029906226BIOSTAR LABORATORIOS SLU1N2026-01-01CALLE LAGUNA DEL MARQUESADO, 19, PLANTA 2 28021 MADRID (Spain) CALLE GARZAS N 18, 28320 PINTO - MADRID (Spain) madrid ES 28021
30299276763029927676BIOSKIN AESTHETICS INC.1Y2026-01-013100 Nw 2nd Ave Ste 407 Boca Raton FL US 33431
30332732303033273230BIOS1N2026-01-011295 Nesbit Drive Nesbit MS US 38651
30342462053034246205BIOSQUARE Inc.1N2026-01-0115, Samsung 1-ro 4-gil Hwaseong-si Gyeonggi KR 18449
30436204143043620414Bioseal1N2026-01-01801 Industrial Blvd Ste 100 Grapevine TX US 76051
14193001419300BIOSYNERGY, INC.1N2020-04-251940 E Devon Ave ELK GROVE VILLAGE IL US 60007

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
587451452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
3083481452071458P990071STOCKERT 70 RADIOFREQUENCY ABLATION GENERATORLPB2000-05-31
587451419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
3083481419020728P990025NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERDRF2000-06-15
587451559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
3083481559194504P950005WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETERLPB1997-09-30
587451163060217P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)QZI2024-11-06
3083481163060217P240006VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)QZI2024-11-06
587451316897506P210027QDOT MICRO™ SystemOAE2022-11-23
3083481316897506P210027QDOT MICRO™ SystemOAE2022-11-23
587451165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
3083481165329946P040036NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETERLPB2006-08-11
587451612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
3083481612366345P030031BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERSOAD2004-11-05
587451366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
3083481366746373P010068NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETEROAD2002-09-27
587451148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
3083481148648591K992965CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085DRF1999-11-26
587451367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
3083481367532919K991531CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078DRF1999-10-04
587451780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
3083481780546532K982740CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813SDYB1998-08-28
2228171310024945K982541VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608FMI1998-10-28
587451063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
3083481063935976K982415CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210DRF1998-08-10
587451078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
3083481078027235K980961CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.DRF1998-05-28
587451942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
3083481942304381K970264CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEMDYB1997-10-28
2228171362394313K960250VACUTAINER BRAND PLUS SERUM & SST TUBESJKA1996-03-29
587451425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
3083481425029505K955817CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETERDRF1996-03-25
587451816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
3083481816500739K954390CORDIS WESTER STAR CATHETERDRF1995-12-21
587451079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
3083481079815869K953768CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1995-11-22
587451700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
3083481700098476K953663CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETERDRF1996-09-18
347421117764780K893814SURGICAL INSTRUMENT KIT, DISPOSABLELRO1989-08-10
587451306939737K892265
3083481306939737K892265
347421309471349K882712STICK SPONGEEFQ1988-08-03
347421957424290K882708GAUZE SPONGE, X-RAY DETECTABLEGDY1988-08-03
347421205351986K882707GAUZE PACKING, X-RAY DETECTABLEGDY1988-08-03
347421529164951K882696DERMICEL, MONTGOMERY STRAPNAD1988-08-26
347421332126698K882695RUBBER BAND, STERILEECI1988-10-13
347421059067784K882694FIXATION DEVICE, TRACH TUBECBH1988-08-15
587451718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
3083481718281991K853383CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SINDYG1985-12-03
587451373562806K841802ELECTRODE CATHETER, ORTHOGONAL TYPELDF1984-10-18
587451836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
3083481836872792K834602SWITCHING UNIT ELECTRODE CATHETERDRF1984-05-09
311951043478316K833904TEMPTREND IIKPD1983-12-27
311951144676174K821312TEMPTREND TEMPERATURE TREND INDICATORKPD1982-05-28
311951525547432K802319HEMOTEMP TMKSE1980-10-10
1128591526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
3083481526307804K254085CARTO™ 3 EP Navigation System V9.0 with PIU PlusDQK2026-01-18
1128591196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3083481196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
3140191196703283K252972CARTO™ 3 EP Navigation System V8.4DQK2026-02-20
1128591889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3083481889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3140191889108606K252302CARTO™ 3 EP Navigation System V8.1DQK2025-08-22
3240111491525407K243788IceCap product lineGXY2025-03-13
587451999568673K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28
3083481999568673K241540NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound CatheterOBJ2024-06-28
3083482045780395K240050SOUNDSTAR™ CRYSTAL Ultrasound CatheterOBJ2024-06-12
587451570366164K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDMTD2023-07-10
3083481570366164K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDMTD2023-07-10
1128591259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3083481259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
3140191259048607K231207CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)DQK2023-09-07
587451838273211K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02
3083481838273211K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyMTD2023-03-02
587452007244677K223766NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16
3083482007244677K223766NUVISION™ NAV Ultrasound CatheterOBJ2023-02-16
1128591886013154K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4DQK2023-02-16
3083481886013154K223733CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4DQK2023-02-16
1128591298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
3083481298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
3140191298566348K221112CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)DQK2022-08-17
1128591446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
3083481446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
3140191446518845K213264CARTO 3 EP Navigation System Version 7.2DQK2021-10-29
587451626964321K211438OPTRELL Mapping Catheter with TRUEref TechnologyMTD2022-03-18
3083481626964321K211438OPTRELL Mapping Catheter with TRUEref TechnologyMTD2022-03-18
587451795239315K211219LASSOSTAR NAV Circular Mapping CatheterDRF2022-01-26
3083481795239315K211219LASSOSTAR NAV Circular Mapping CatheterDRF2022-01-26
587451396086927K201775NuVision ICE CatheterOBJ2021-03-05
3083481396086927K201775NuVision ICE CatheterOBJ2021-03-05
587451457602595K201750Pentaray Nav eco High-Density Mapping CatheterMTD2020-08-06
3083481457602595K201750Pentaray Nav eco High-Density Mapping CatheterMTD2020-08-06
1128591079351507K200484CARTO® 3 EP Navigation System with Signal Processing UnitDQK2020-11-25
3083481079351507K200484CARTO® 3 EP Navigation System with Signal Processing UnitDQK2020-11-25
587451271511203K193632LassoStar Circular Mapping CatheterDRF2020-06-30
3083481271511203K193632LassoStar Circular Mapping CatheterDRF2020-06-30
587451124588025K193237Carto Octaray Mapping Catheter with Trueref TechnologyMTD2020-07-31
3083481124588025K193237Carto Octaray Mapping Catheter with Trueref TechnologyMTD2020-07-31
2042341971021489K192480Torpedo Gelatin FoamKRD2019-11-21
1128591724992981K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK2019-07-20
3083481724992981K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesDQK2019-07-20
2042341785192182K183578Torpedo Gelatin FoamKRD2019-06-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRF812022-01-26
DQK492026-02-20
MTD182023-07-10
OBJ132024-06-28
DYB92017-07-25
KRD82019-11-21
LPB82006-08-11
OAD62004-11-05
DSA32000-07-21
DYG31985-12-03
FMF22018-05-10
MNW22014-09-23
GDY21988-08-03
LDF21984-10-18
KPD21983-12-27
GXY12025-03-13
NOY12017-06-21
PGW12016-10-24
NFO12014-04-30
DXN12013-09-04
OAN12009-01-27
DQO12006-08-09
DQX12006-06-02
NAJ12002-11-22
HCG12001-06-21
FMI11998-10-28
JKA11996-03-29
LRO11989-08-10
ECI11988-10-13
NAD11988-08-26
CBH11988-08-15
EFQ11988-08-03
KSE11980-10-10

NDC#

PMA#

QDOT MICRO™ System

2022-11-23

Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE  Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No

Biosense Webster Cables

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS056 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

Celsius FLTRR, EZ Steer Nav DS Catheter

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,

2022-09-30

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

NAVISTAR

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

CELSIUS

2022-09-09

Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS084 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reas...

8mm Dual Sensor (DS) Catheters

2022-09-09

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...

SmartAblate Irrigation Tubing Set and nGEN Pump

2022-06-08

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

BioFreedom Drug Coated Coronary Stent System

2022-04-14

Biosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No

SmartAblate Irrigation Tubing Set

2022-03-15

BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...

200 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

WINSIX Implant System: Extreme Abutment System - The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). ABUTMENTS are used for creation of screwed temporary or fixed elements. They have different features to allow the physician to adapt to the different anatomical situation.Healing screws are used to cover the fixtures and to model the mucosa during her healing.

BIOSAF IN SRL

2016-09-20

80 records. Showing 1-40. Next