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

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BLADE ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450363096·

MICASEPT DEBAKEY ORGAN GRASPER

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011007·MICASEPT DEBAKEY ORGAN GRASPER WITH RATCHET CURVED

MOIST PUNCTAL PLUG SYSTEM

FDA 510(k)
FDA Unclassified ·Unknown

ARTHROCARE CONTROLLER, ARTHROCARE CABLE, FOOTSWITCH, POWERCORD

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code NVY·January 13, 2014

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·8010379 DEPUY INTL., LTD.·Product code KWA·May 3, 2013

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011

cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

FDA Enforcement
Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 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