16 results
·
20ms
·
Sources: EU EUDAMED, US FDA
ACTH RADIOIMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Arx
FDA UDI
Life Spine, Inc.·00190837190392·
Arx
FDA UDI
Life Spine, Inc.·00190837131722·
Arx
FDA UDI
Life Spine, Inc.·00190837188924·
Arx
FDA UDI
Life Spine, Inc.·00190837175795·
Arx
FDA UDI
Life Spine, Inc.·00190837131746·
Arx
FDA UDI
Life Spine, Inc.·00190837172855·
Arx
FDA UDI
Life Spine, Inc.·00190837131715·
Arx
FDA UDI
Life Spine, Inc.·00190837131739·
INFANT OXYGEN TREATMENT HOOD
FDA 510(k)
FDA Class 2
·Anesthesiology
Aquarius 8600 Digital Radiography Sensor
FDA 510(k)
FDA Class 2
·Radiology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
CAPSURE EPI
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·October 31, 2012
CELL-DYN SAPPHIRE VENT HEAD ASSEMBLY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·August 23, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018