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Merit Medical Systems, Inc.

263 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-8-038, 8.5 F, Sterile EO, Mer recall (Z-0611-2009)Merit Medical Systems, Inc.2009-01-13
ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit recall (Z-0612-2009)Merit Medical Systems, Inc.2009-01-13
ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Meri recall (Z-0613-2009)Merit Medical Systems, Inc.2009-01-13
ReSolve Hydrophilic Coated Locking Biliary Catheter, REF RBC-14-038, 14F, Sterile EO, Meri recall (Z-0614-2009)Merit Medical Systems, Inc.2009-01-13
10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO, Merit Medical Systems, In recall (Z-2366-2008)Merit Medical Systems, Inc.2008-09-21
12ml Control Syringe, REF/CAT No.: CCS601 Version B, Sterile R, Merit Medical Systems, Inc recall (Z-2367-2008)Merit Medical Systems, Inc.2008-09-21
12ml Control Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO, Merit Medical Systems, I recall (Z-2368-2008)Merit Medical Systems, Inc.2008-09-21
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile, Merit Medical Systems, Inc., 1600 recall (Z-1808-2008)Merit Medical Systems, Inc.2008-09-19
Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02159A, Sterile, Merit Medical Systems, Inc., 1600 recall (Z-1809-2008)Merit Medical Systems, Inc.2008-09-19
Fluid Administration Set, Custom Kit, REF: K09-05336DP, Caution: For manufacturing, proces recall (Z-1800-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-05785FP, Caution: For manufacturing, proces recall (Z-1801-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-05971AP, Caution: For manufacturing, proces recall (Z-1802-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-02842CP, Caution: For manufacturing, proces recall (Z-1803-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-09938P, Caution: For manufacturing, process recall (Z-1804-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-09051P, Caution: For manufacturing, process recall (Z-1805-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K09-01280JP, Caution: For manufacturing, proces recall (Z-1806-2008)Merit Medical Systems, Inc.2008-09-11
Fluid Administration Set, Custom Kit, REF: K10-01795DP, Caution: For manufacturing, proces recall (Z-1807-2008)Merit Medical Systems, Inc.2008-09-11
Fountain Infusion System, 4F, REF IS4-90-50, Sterile, Merit Medical Systems, Inc., South J recall (Z-2107-2008)Merit Medical Systems, Inc.2008-09-11
CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K12T-02449B, Merit Medical Systems recall (Z-2197-2008)Merit Medical Systems, Inc.2008-09-11
Custom Kit, Custom Angiographic Kit, REF: K05-YS1025, Sterile, Merit Medical Systems, Inc. recall (Z-1699-2008)Merit Medical Systems, Inc.2008-09-04
Custom Kit, Custom Angiographic Kit, REF: K05-YS1032, Revision A, Sterile, Merit Medical S recall (Z-1700-2008)Merit Medical Systems, Inc.2008-09-04
Custom Kit, REF: K05-00843, Revision L, Sterile, Merit Medical Systems, Inc., South Jordan recall (Z-1701-2008)Merit Medical Systems, Inc.2008-09-04
Merit Medical Surgical Convenience Kits, Custom and SPPT, Merit Medical, South Jordan, UT recall (Z-1262-2007)Merit Medical Systems, Inc2007-09-25
Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP, Merit Medical Systems, recall (Z-0843-2007)Merit Medical Systems, Inc.2007-05-31
Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid administration sets, 40000. recall (Z-0844-2007)Merit Medical Systems, Inc.2007-05-31
Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, M recall (Z-0845-2007)Merit Medical Systems, Inc.2007-05-31
Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP, Merit Medical Systems, So recall (Z-0846-2007)Merit Medical Systems, Inc.2007-05-31
Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., recall (Z-0847-2007)Merit Medical Systems, Inc.2007-05-31
StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Med recall (Z-0627-2007)Merit Medical Systems, Inc2007-03-15
StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Me recall (Z-0628-2007)Merit Medical Systems, Inc2007-03-15
EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain. recall (Z-0629-2007)Merit Medical Systems, Inc2007-03-15
IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface recall (Z-0348-06)Merit Medical Systems, Inc2006-01-06
IntelliSystem II Thermal Dot Matrix printer 110 V adapter and fiber optic serial interface recall (Z-0349-06)Merit Medical Systems, Inc2006-01-06
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial int recall (Z-0350-06)Merit Medical Systems, Inc2006-01-06
IntelliSystem II Thermal Dot Matrix printer 220 V 50 Hz adapter and fiber optic serial int recall (Z-0351-06)Merit Medical Systems, Inc2006-01-06
Viceroy Inflation Syringe, 60mL, Sterile, Rx only. recall (Z-0290-06)Merit Medical Systems, Inc2005-12-17
Viceroy Inflation Syringe, 60mL, without gauge. recall (Z-0291-06)Merit Medical Systems, Inc2005-12-17
Merit Custom Procedure Kit recall (Z-0077-06)Merit Medical Systems, Inc2005-10-21
Merit Custom Procedure Kit recall (Z-0078-06)Merit Medical Systems, Inc2005-10-21
Merit Custom Procedure Kit recall (Z-0079-06)Merit Medical Systems, Inc2005-10-21
Merit Custom Procedure Kit recall (Z-0080-06)Merit Medical Systems, Inc2005-10-21
Merit Custom Procedure Kit recall (Z-0081-06)Merit Medical Systems, Inc2005-10-21
Safety Paracentesis Procedure Tray recall (Z-0190-05)Merit Medical Systems, Inc2004-11-11
Custom Convenience Kit recall (Z-0191-05)Merit Medical Systems, Inc2004-11-11
8 ml Inject8 Coronary Control Syringe, sterile. recall (Z-0048-05)Merit Medical Systems, Inc2004-10-28
10 ml Inject 10 Palm Pad, sterile recall (Z-0049-05)Merit Medical Systems, Inc2004-10-28
Convenience Kits containing Inject8 or Inject10 syringes. recall (Z-0050-05)Merit Medical Systems, Inc2004-10-28
Merit MAK Mini Access Kit, 4 French (1.3mm) recall (Z-1309-04)Merit Medical Systems, Inc2004-08-04
Merit MAK Mini Access Kit, 4 French (1.3mm) recall (Z-1310-04)Merit Medical Systems, Inc2004-08-04
Merit MAK Mini Access Kit, 4 French (1.3mm) recall (Z-1311-04)Merit Medical Systems, Inc2004-08-04
UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medic recall (Z-0158-04)Merit Medical Systems, Inc2003-11-27
UHF Grollman Pigtail Long Tip Non-wirebraid, 7FG, 110 cm, Angiographic Catheter, Sterile, recall (Z-0159-04)Merit Medical Systems, Inc2003-11-27
Monarch Inflation Device and Fluid Dispensing Syringe - Latex Free MERIT MEDICAL. Sterile recall (Z-0137-04)Merit Medical Systems, Inc2003-11-19
IntelliSystem25 Inflation Device and Fluid Dispensing Syringe - Label on package reads in recall (Z-0138-04)Merit Medical Systems, Inc2003-11-19
VacLok Syringe. Label reads in part: ''VACLOC SYRINGE 60 ml VACLOF SYRINGE-FIXED MALE LUER recall (Z-0139-04)Merit Medical Systems, Inc2003-11-19
Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if recall (Z-0140-04)Merit Medical Systems, Inc2003-11-19
Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Ster recall (Z-0141-04)Merit Medical Systems, Inc2003-11-19
Waste Collection Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Ste recall (Z-0142-04)Merit Medical Systems, Inc2003-11-19
Inject 10 Coronary Control Syringe (CCS), 10ml recall (Z-0912-03)Merit Medical Systems, Inc2003-06-05
Custom Kit recall (Z-0913-03)Merit Medical Systems, Inc2003-06-05
Custom Angiographic Kit. recall (Z-0620-03)Merit Medical Systems, Inc2003-03-06
Custom Angiographic Kit recall (Z-0621-03)Merit Medical Systems, Inc2003-03-06
Custom Angiographic Kit recall (Z-0622-03)Merit Medical Systems, Inc2003-03-06
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Every clearance here is in the API, with alerts when new ones post.