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

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Prase PEEK Anterior Cervical Interbody Spacer

FDA 510(k)
FDA Class 2 ·Orthopedic

NA

FDA UDI
Synthes GmbH·10886982145055·2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112571·BARRON CORNEAL PUNCH 6.5MM

GE ROAD WARRIOR PET CT IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

R&D PROJECT DW271#11A

FDA 510(k)
FDA Class 2 ·Dental

PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·October 17, 2008

JUGGERKNOT SINGLE LOADED SZ. 1

FDA Adverse Event
Injury ·BIOMET SPORTS MEDICINE, INC.·Product code MBI·August 11, 2011

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·July 2, 2013

Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

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