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