9 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Polysmith Sleep System
FDA 510(k)
FDA Class 2
·Neurology
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
FDA 510(k)
FDA Class 2
·Orthopedic
VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 6, 2025
PLUM A+ DRIVER ED 2
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 24, 2013
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·June 20, 2011
PUMP MMT-522PNAL PRDGM INS CL EN PW
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 27, 2008
VARIABLE SELF-DRILLING SCREW DIAM. 4X14MM (2X)
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWQ·October 4, 2017
Surgical Table Cushion (HybriGel Pads) HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
FDA Enforcement
Class II
·Terminated·Berchtold Corp.·June 15, 2016