12 results · 21ms · Sources: EU EUDAMED, US FDA

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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