8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
THIOGLYCOLLATE MED. W/VITAMIN K-1
FDA 510(k)
FDA Class 1
·Microbiology
PERKINELMER 226 SAMPLE COLLECTION DEVICES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
2.0MM IMF SCREW SELF-DRILLING 8MM
FDA Adverse Event
Malfunction
·SYNTHES MEZZOVICO·Product code DZL·April 12, 2016
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2014
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·November 6, 2012
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Injury
·OBTECH MEDICAL SARL_·Product code LTI·August 31, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022