8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
FDA 510(k)
FDA Class 1
·General Hospital
U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118
FDA 510(k)
FDA Class 2
·General Hospital
PICA WHOLE-BODY MRI SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 26, 2013
PRIMA ESTH CON ZI ABUT SD 4.0X2MM
FDA Adverse Event
Malfunction
·KEYSTONE DENTAL·Product code NHA·July 19, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 21, 2014
Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Number 6290-00-704. Per the Natural-Knee II Primary System Surgical Technique, the patellar bushing is placed on the cut surface of the patella and used as a guide for the matching size patella cutter
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·September 10, 2014
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018