15 results
·
28ms
·
Sources: EU EUDAMED, US FDA
MEDI-TRACE EEG CREME
FDA 510(k)
FDA Class 2
·Neurology
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS
FDA 510(k)
FDA Class 2
·General Hospital
G7 54-F PPS LIMITED ACETABULAR SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·October 2, 2017
DELTA CER FEM HD 32/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·October 19, 2017
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 18, 2024
ECHO BI-METRIC 13MMX145MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 2, 2017
DELTA CER FEM HD 32/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·October 5, 2017
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 2, 2024
M2A-MAGNUM PF CUP 56ODX50ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 5, 2014
ENRHYTHM DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DXY·October 15, 2012
OCTRODE PERCUTANEOUS LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·August 4, 2010
ECHO POR FMRL NC 13X145MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·October 16, 2017
DELTA CER FEM HD 32/+3MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JDI·October 5, 2017
Promote, Sterile EO, Model #/ Part #: 3207-30/60010740-207, 60010740-407; 3207-36/60010743-207, 60010743-407; 3213-36/50022126-001, 60013879-307, 60013879-407, 60013879-707; CD3211-36/100006984,100012548, 100012550, 100016680, 100031621, 100035618, 100035619, 100042487, 100047194; CD3211-36Q/100004091, 100004093,100019784, 100035620, 100042486, 100047054; CD3215-36/100006995, 100010246, 100010247, 100010249, 100010250, 100012569, 100012570, 100034981, 100046577, 100046802, 60019065; CD3215-36Q/100004059, 100004060, 100004061, 100023304, 100030590, 100033678, 100042492, 100046803, 100046906
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018