10 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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Augment Off-Axis Instrument System
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMARC COAXIAL NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ART ANTERIOR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2024
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 29, 2024
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 6, 2014
MAESTRO STRAIGHT AM ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBB·July 22, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
GOODBABY·Product code INM·July 18, 2013
IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 30, 2024
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025