11 results
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18ms
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Sources: EU EUDAMED, US FDA
BARD SHORT RIGID URETEROSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sterile C-Arm / mobile x-ray cover
FDA UDI
Spiggle & Theis Medizintechnik GmbH·04250676712189·for Siemens Arcadis-Avantic, three piecs
4 piec...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526785021·EPICOMED ELB SUPPORT SAND III
Mariner
FDA UDI
Seaspine Orthopedics Corporation·10889981134488·Non-Ratcheting Axial Handle, Cannulated , A/O
QRS CARD S-T SEGMENT ANALYSIS PATIENT MONITORING SYSTEM MODEL: QRS CARD USB
FDA 510(k)
FDA Class 2
·Cardiovascular
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 16, 2020
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 27, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 16, 2010
6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 12, 2012
Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·October 18, 2023