15 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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DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331134036·russian tissue forceps, 10" (25.0 cm)
SIEMENS 1.5T TXRX 15 CH KNEE
FDA Adverse Event
Other
·QUALITY ELECTRODYNAMICS·Product code MOS·October 5, 2011
ZENITH PEDICLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T
FDA 510(k)
FDA Class 2
·Radiology
PRADO™ Lumbar Interbody Fusion System
FDA UDI
Pt. Solutions, LLC·G616RAFS182636110·NON-STERILE PLANAR, PRADO A ASYMMETRIC PEEK IBF...
PRADO™ Lumbar Interbody Fusion System
FDA UDI
Pt. Solutions, LLC·G616RAFS182636120·NON-STERILE PLANAR, PRADO A SYMMETRIC PEEK IBFD...
PRADO™ Lumbar Interbody Fusion System
FDA UDI
Pt. Solutions, LLC·G616RAFS182636060·NON-STERILE PLANAR, PRADO A SYMMETRIC PEEK IBFD...
POLYMOBIL PLUS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHINEERS AG·Product code IZL·February 24, 2026
BD SYRINGE 60ML CATHETER TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·November 7, 2021
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 17, 2014
TERUMO STERNAL SAW
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GFA·July 5, 2011
6000CMS
FDA Adverse Event
Malfunction
·MOOG DEIVCE GROUP·Product code FRN·June 11, 2013
MOBILETT ELARA MAX
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IZL·December 18, 2020
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021