11 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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Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
FDA 510(k)
FDA Class 2
·Clinical Chemistry
24PW - Piedmont Natural Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130736·24PW - Piedmont Natural Gas - Poly White
SUPER CHAIR FOR KIDS BY ORION
FDA 510(k)
FDA Class 1
·Physical Medicine
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 4/12 MM RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 8, 2017
Widex
FDA UDI
Widex A/S·05706069792836·Widex UNIQUE U-PA (Titan grey ) 50, RC coil
Widex
FDA UDI
Widex A/S·05706069819533·Widex UNIQUE U-FS (Titan grey ) 50, Telecoil, R...
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 15, 2011
MULTISTIX 8 SG
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JIO·May 10, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·September 15, 2008
RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014