29 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
FDA 510(k)
FDA Class 2
·Anesthesiology
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810756·Iris Scissors, Straight, Ribbon Handle, 11.5cm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450405536·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450139899·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450397374·
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345024045·Paddle Shaver, 9mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0103090·Shaver, Closed, 9mm
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018
BLASTOCYST FREEZE MEDIUM, BLASTOCYST THAW MEDIUM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR
FDA 510(k)
FDA Unclassified
·Unknown
CAPSTONE SPINAL SYSTEM
FDA Adverse Event
Injury
·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Recall
Terminated
·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017
CONCERTO CRT-D DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·April 10, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
ZENITH AAA ILIAC LEG GRAFT
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·May 22, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·September 7, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code NQP·July 6, 2012
Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.
FDA Enforcement
Class II
·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code NQP·July 6, 2012