19 results · 23ms · Sources: EU EUDAMED, US FDA

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DRIED GRAM NEGATIVE MIC/COMBO PANELS

FDA 510(k)
FDA Class 2 ·Microbiology

Affiniti™

FDA UDI
TORNIER, INC.·00846832001958·

Promolux Polymer H-pink

FDA UDI
Merz Dental GmbH·D7091020037·Promolux Polymer H-pink, 1000g

AOS SMALL BONE REAMER Ø3.7 x 328mm

FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665028867·

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

ROSA POLYAXIAL REFERENCE SIZE 3

FDA UDI
Orthosoft Inc·00889024674776·

LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS

FDA 510(k)
FDA Class 2 ·Dental

MONOFILAMENT BIOSYN SUTURE

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

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval
FDA Class 2 ·FX MINIRAIL RX PTCA CATHETER

ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code FGE·February 24, 2017

ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

FDA Adverse Event
Malfunction ·COOK INC·Product code NIO·July 25, 2017

VALIANT CAPTIVIA THORACIC STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·March 25, 2013

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·March 12, 2014

IN TOUCH ZU

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FNL·March 9, 2011

VNGD ANT STBLZD BRG 10X79

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 14, 2020

1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

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

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012