11 results · 20ms · Sources: EU EUDAMED, US FDA

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ORTHOFIX VOLAR DISTAL RADIAL PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

HairCheck-DT (PCP)

FDA UDI
Quest Diagnostics·00868586000254·HairCheck-DT (PCP) is an ELISA test kit used fo...

JOBST forMen

FDA UDI
BSN MEDICAL, INC.·04042809869804·FOR MEN 30-40 MM HG THIGH MICRO DOT BAND CLOSED...

PORTABLE INTENSIVE CARE UNIT

FDA 510(k)
FDA Class 3 ·Cardiovascular

NICOLET VASOGUARD

FDA 510(k)
FDA Class 2 ·Cardiovascular

EMAX 2 PLUS MOTOR

FDA Adverse Event
Malfunction ·THE ANSPACH EFFORT, INC.·Product code HBC·April 2, 2013

CONTAK RENEWAL 3 RF HE

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

SYNCHRON® LX20 PRO ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 7, 2011

REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).

FDA Enforcement
Class II ·Ongoing·ICU Medical, Inc.·May 19, 2021

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

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024