22 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BEACON STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450639931·
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012740·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012917·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012900·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012757·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012733·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012726·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012887·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012894·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012870·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
PINNACLE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295012764·PINNACLE HIP SOLUTIONS MARATHON BANTAM POLYETHY...
VOCARE MYHEALTH TABLET
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO PARA 5X
FDA 510(k)
FDA Class 2
·Hematology
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
FDA Recall
Open, Classified
·Ortho-Clinical Diagnostics, Inc.·Product code JJE·August 9, 2023
INTEGRITY RX
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MAF·May 21, 2013
VISION HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Other
·GISH BIOMEDICAL, INC.·Product code DTZ·June 1, 2011
HARMONIC ACE 23 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 13, 2008
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
FDA Enforcement
Class II
·Ongoing·Ortho-Clinical Diagnostics, Inc.·October 11, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015