19 results
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33ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RAPID FERMENTATION AGAR (RFA)
FDA 510(k)
FDA Class 1
·Microbiology
DSQ Alert Internal Control set IC1
FDA UDI
Elitechgroup Mdx LLC·03661540952791·The DSQ Alert Internal Control Set IC1 contains...
MGB Alert® Internal Control set IC1 DSQ
FDA UDI
Elitechgroup Mdx LLC·03661540952333·The MGB Alert Internal Control Set IC1 DSQ cont...
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013400·Adjustable Elbow Brace, Right
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013394·Adjustable Elbow Brace, Left
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221109972·3M™ Unitek™ Pliers/Cutter Combo, 800-705, 1/Ea
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
FDA 510(k)
FDA Class 2
·Orthopedic
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 8, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·October 22, 2012
LAMITRODE TRIPOLE 16C LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 12, 2010
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
PFNA BLADE PERF L115 TAN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code KTW·November 10, 2017
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021