Home › Device types › MGB
Device, Hemostasis, Vascular
FDA product code MGB · Class 3 · Unknown
62
Registered devices
123,916
Adverse events
12
Recalls
0
510(k) clearances
Devices with this code
MANTA — ESSENTIAL MEDICAL, INC.MYNXGRIP — Cordis US Corp.ANGIO-SEAL — TERUMO MEDICAL CORPORATIONCelt ACD PLUS Vascular Closure Device 7F — VASORUM LIMITEDMANTA — TELEFLEX INCORPORATEDMANTA — TELEFLEX INCORPORATEDAngio-Seal™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONMynxGrip Vascular Closure Device (5F) — Access Closure, Inc.MANTA — ESSENTIAL MEDICAL, INC.MYNXGRIP — Cordis US Corp.MANTA — TELEFLEX INCORPORATEDAngio-Seal™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONCardiva VASCADE 6/7F VCS — CARDIVA MEDICAL, INC.Angio-Seal™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONAngio-Seal™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIONMANTA — ESSENTIAL MEDICAL, INC.Cross-Seal — MEDEON BIODESIGN, INC.StarClose SE™ — ABBOTT VASCULAR INC.MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F — Cordis US Corp.Celt ACD PLUS Vascular Closure Device 5F — VASORUM LIMITEDAngio-Seal™ — ST. JUDE MEDICAL CARDIOVASCULAR DIVISIOND-STAT — TELEFLEX INCORPORATEDCelt ACD PLUS Vascular Closure Device 6F — VASORUM LIMITEDCelt ACD Vascular Closure Device 7F — VASORUM LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-28 | Cordis US Corp | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 |
| 2023-11-28 | Cordis US Corp | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 |
| 2023-04-12 | TELEFLEX LLC | The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond |
| 2018-04-09 | Terumo Medical Corp | Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products |
| 2017-02-10 | Abbott Vascular | Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip. |
| 2016-07-13 | AccessClosure, Inc., A Cardinal Health Company | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that |
| 2012-10-29 | Cordis Corporation | Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standar |
| 2009-05-06 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation | Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure. |
| 2006-06-07 | St. Jude Medical / Daig Division | The Angio Seal VIP 6F devices were incorrectly packaged with a 0.038'' guidewire vs. the required 0.035'' guidewire. |
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