6,334 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TAUT BALLOON CATHETER, MODEL 50640
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROLLO 110X30X12E.PRINTER.
FDA UDI
AB MEDICA GROUP, S.A.·08428763004691·
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037313701·STABILITY TRIAL CUP Ø32 + 18
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033435519·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033435489·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033435502·
CERES
FDA UDI
SPINAL ELEMENTS, INC.·00840606150330·CERES® DRILL, 18M
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033435496·
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm
NA
FDA UDI
Orthosoft Inc·00889024305281·
NORMED MANDIBULAR FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Dental
LIVESURE MORPHINE SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat Height: 21 1/4"; Seat Size: 14" x 12 3/4"; Handle Height: 31" - 36"; Width Between Handles: 18"; Weight: 19 Lbs; Walking assistance device.
FDA Enforcement
Class II
·Terminated·Briggs Medical Service Company d.b.a. Mabis·November 5, 2014
3D MAX MESH
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·March 11, 2013
OT ULTRAMINI METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·March 8, 2011
IDENTITY ADX DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
FDA Recall
Terminated
·Luminex Corporation·Product code PAM·December 26, 2018
IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 8MM
FDA Adverse Event
Malfunction
·ZIMMER DENTAL·Product code DZE·December 19, 2019
IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·August 7, 2019
IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
FDA Adverse Event
Malfunction
·ZIMVIE US CORP LLC·Product code DZE·May 29, 2026