14 results
·
19ms
·
Sources: EU EUDAMED, US FDA
PSYCHEMEDICS METHAMPHETAMINE EIA
FDA 510(k)
FDA Class 2
·Clinical Toxicology
SureFISH MALT1 BA P200
FDA UDI
AGILENT TECHNOLOGIES, INC.·05700574008932·SureFISH MALT1 BA P200
MAXCUT CARBIDE BUR (100/pk) FG 169L
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811119271·MAXCUT CARBIDE BUR (100/pk) Shape: Plain Taper ...
MECTALIF
FDA 510(k)
FDA Class 2
·Orthopedic
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ACCUJECT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDICEL AG·Product code HQL·November 30, 2012
ENVISTA INTRAOCULAR LENS
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code HQL·November 30, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 8, 2025
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·May 14, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 2, 2011
CONTOUR TEST STRIPS (50)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·August 8, 2008
ADVANTA V12 COVERED STENT
FDA Adverse Event
Malfunction
·ATRIUM MEDICAL CORPORATION·Product code NIO·March 11, 2021
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014