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Guidant Corporation

42 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Guidant CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219 recall (Z-0269-2007)Guidant Corporation2006-12-16
Guidant Zoom Latitude Programming System, Model 3120, Programmer/Recorder/Monitor (PRM). A recall (Z-0002-2007)Guidant Corporation2006-10-12
Guidant CONTAK RENEWAL 3 (models H170, H173, H175), CONTAK RENEWAL 3 HE (models H177, H179 recall (Z-1192-06)Guidant Corporation2006-07-04
VITALITY HE (model T180) Implantable Cardioverter Defibrillator (ICD). Sterile EO. Guidant recall (Z-1193-06)Guidant Corporation2006-07-04
Guidant CONTAK RENEWAL 3 AVT (models M150, M155), CONTAK RENEWAL 3 AVT HE (models M157, M1 recall (Z-1194-06)Guidant Corporation2006-07-04
CONTAK RENEWAL 3 CRT-D (model no. H170, H175, H177, H179). Cardiac Resynchronization Thera recall (Z-0890-06)Guidant Corporation2006-05-23
CONTAK RENEWAL 4 CRT-D (model no. H190, H195, H199). Cardiac Resynchronization Therapy Def recall (Z-0891-06)Guidant Corporation2006-05-23
VITALITY DS (model T125) and VITALITY 2 (models T165, 175) ICD (implantable cardiac defibr recall (Z-0892-06)Guidant Corporation2006-05-23
CONTAK RENEWAL 3 RF (models H210, H215), CONTAK RENEWAL 3 RF HE (models H217, H219), CONTA recall (Z-0863-06)Guidant Corporation2006-05-16
Guidant CONTAK RENEWAL 3 (models H170,H175) CONTAK RENEWAL 3 HE (models H177, H179) Cardia recall (Z-0825-06)Guidant Corporation2006-05-02
Guidant CONTAK RENEWAL 4 (models H190, H195) CONTAK RENEWAL; 4 HE (model H197). Cardiac Re recall (Z-0826-06)Guidant Corporation2006-05-02
Guidant CONTAK RENEWAL 4 AVT (model M170). Cardiac Resynchronization Therapy Defibrillator recall (Z-0827-06)Guidant Corporation2006-05-02
Guidant VITALITY HE Implantable Cardioverter Defibrillator (model T180). Sterile EO. Guida recall (Z-0828-06)Guidant Corporation2006-05-02
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0 recall (Z-0191-06)Guidant Corporation2005-11-23
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and recall (Z-0192-06)Guidant Corporation2005-11-23
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (model 1194); and recall (Z-0193-06)Guidant Corporation2005-11-23
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD ( recall (Z-0194-05)Guidant Corporation2005-11-23
Guidant INSIGNIA I Entra family of pacemakers includes the following: SSI (model numbers 0 recall (Z-0187-06)Guidant Corporation2005-09-24
Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and recall (Z-0188-06)Guidant Corporation2005-09-24
Guidant INSIGNIA I Plus family of pacemakers includes the following: SR (models1194); and recall (Z-0189-06)Guidant Corporation2005-09-24
Guidant INSIGNIA I AVT family of pacemakers includes the following: SSI (model 482), VDD ( recall (Z-0190-06)Guidant Corporation2005-09-24
Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/D recall (Z-1441-05)Guidant Corporation2005-08-30
Guidant Lead Tunneler Kit model 6927. Accessory Kit for use with the Endotak SQ Lead Array recall (Z-1442-05)Guidant Corporation2005-08-30
Oscor Introducer Kits Model LLP series. Luer-Lock Peel-Away Introducer Set. Each set conta recall (Z-1443-05)Guidant Corporation2005-08-30
PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have bee recall (Z-1064-05)Guidant Corporation2005-08-03
CONTAK RENEWAL 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy Defibrillator. recall (Z-1065-05)Guidant Corporation2005-08-03
DISCOVERY (model nos. 1174, 1175, 1273, 1274 and 1275) pacemaker. Sterilized with gaseous recall (Z-1032-05)Guidant Corporation2005-07-28
MERIDIAN (model nos. 476, 976, 1176 and 1276) pacemaker. Sterilized with gaseous ethylene recall (Z-1033-05)Guidant Corporation2005-07-28
PULSAR and PULSAR MAX (model nos. 470, 870, 970, 972, 1170, 1171, 1172, 1270 and 1272) pac recall (Z-1034-05)Guidant Corporation2005-07-28
PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene recall (Z-1035-05)Guidant Corporation2005-07-28
DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and 1286) pacemaker. recall (Z-1036-05)Guidant Corporation2005-07-28
VIRTUS PLUS II (model nos. 1380 and 1480) pacemaker. Sterilized with gaseous ethylene oxid recall (Z-1037-05)Guidant Corporation2005-07-28
INTELIS II (model nos. 1349, 1384, 1385, 1483, 1484, 1485 and 1499) pacemaker. Sterilized recall (Z-1038-05)Guidant Corporation2005-07-28
CONTAK TR (Model no. 1241) pacemaker. Sterilized with gaseous ethylene oxide. Guidant Corp recall (Z-1039-05)Guidant Corporation2005-07-28
Ventak PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator (AICD), Dua recall (Z-0906-05)Guidant Corporation2005-06-30
CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibri recall (Z-0907-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 2 (model H155) Heart Failure Device. Sterilized with gaseous ethylene oxide recall (Z-0908-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 3 CRT-D (model no. H170, H173, H175) and CONTAK RENEWAL 3 HE CRT-D(model no recall (Z-0949-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 4 CRT-D (model no. H190 and H195) and CONTAK RENEWAL 4 HE CRT-D (model no. recall (Z-0950-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 3 AVT CRT-D (model no. M150 and M155) and CONTAK RENEWAL 3 AVT HE CRT-D(mod recall (Z-0951-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 4 AVT CRT-D (model no. M170 and M175) and CONTAK RENEWAL 4 AVT HE CRT-D (mo recall (Z-0952-05)Guidant Corporation2005-06-30
CONTAK RENEWAL 4 RF (model no. H230 and H235) and CONTAK RENEWAL 4 RF HE (model no. H239). recall (Z-0953-05)Guidant Corporation2005-06-30

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Every clearance here is in the API, with alerts when new ones post.