14 results · 29ms · Sources: EU EUDAMED, US FDA

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FIRMM

FDA 510(k)
FDA Class 2 ·Radiology

Power Pin

FDA UDI
TP ORTHODONTICS INC·00192029028087·Tooth Colored

Power Pin

FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746056314·LONG LEG POWER PIN 50/PKG

AQUACEL FOAM

FDA Adverse Event
Malfunction ·CONVATEC LTD·Product code NAC·December 29, 2023

AQUACEL FOAM

FDA Adverse Event
Malfunction ·CONVATEC LTD·Product code NAC·December 29, 2023

POWDER FREE STERILE LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

MILLENNIUM 5000 MEUROVASCULAR COIL

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·November 24, 2015

ENDURANT ABDOMINAL STENT GRAFT

FDA Adverse Event
Malfunction ·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·July 29, 2011

ENTERAL SAFE FEEDING TUBE, 5 FR X 36" POLYURET

FDA Adverse Event
Malfunction ·DEROYAL INDUSTRIES·Product code FPD·September 16, 2014

TI NUT 11MM WIDTH ACROSS FLATS

FDA Adverse Event
Injury ·SYNTHES USA·Product code KWQ·July 2, 2013

BD PHASEAL¿ PROTECTOR P55

FDA Adverse Event
Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code ONB·March 23, 2023

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

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