8 results
·
16ms
·
Sources: EU EUDAMED, US FDA
CHICK/REISON PATIENT EMERG. TROLLEY
FDA 510(k)
FDA Class 2
·Radiology
HUMPHREY A.D.E. SYSTEM
FDA 510(k)
FDA Class 1
·Anesthesiology
LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN
FDA 510(k)
FDA Class 2
·Hematology
SROM*STM LG 36+8L 20X15X225R
FDA Adverse Event
Malfunction
·DEPUY IRELAND REG. # 9616671·Product code JDI·May 28, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·November 15, 2012
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·September 10, 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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015