11 results · 27ms · Sources: EU EUDAMED, US FDA

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Prase-AP Anterior Cervical Plate System

FDA 510(k)
FDA Class 2 ·Orthopedic

Blade Scalpel

FDA UDI
KATENA PRODUCTS, INC.·00841668113547·SLIT BLADE 3.2MM ANGLED (BX/5)

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112991·CORNEAL TREPHINE BLADE16MM

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112632·BARRON CORNEAL PUNCH 8.0MM

BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)

FDA 510(k)
FDA Class 1 ·General Hospital

DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER

FDA 510(k)
FDA Class 2 ·Anesthesiology

CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

FDA Adverse Event
Death ·EDWARDS LIFESCIENCES·Product code LWR·October 16, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

RELIANCE SYNERGY WASHER

FDA Adverse Event
STERIS CANADA CORPORATION·Product code MEC·July 2, 2013

Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). 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