12 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PolyLock Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112946·CORNEAL TREPHINE BLADE8.25MM
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112526·BARRON VACUUM TREPHINE 8.25MM
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COCR HEAD 28/+4 'L' 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code MEH·January 26, 2026
UNICEL ¿ DXI 800 ACCESS ® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·August 11, 2011
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·October 27, 2014
PROMUS ELEMENT? PLUS
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·July 2, 2013
PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code LPH·October 17, 2025
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code QJR·September 8, 2020
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012