13 results · 18ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION

FDA 510(k)
FDA Class 2 ·Anesthesiology

MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

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

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

PROFILE BIABUT 4.0 -Ø5.5

FDA Adverse Event
Injury ·DENTSPLY IMPLANTS MANUFACTURING GMBH·Product code DZE·February 24, 2026

TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code DZL·September 6, 2017

COULTER® LH780 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·April 11, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

CONTOUR TEST STRIPS (50)

FDA Adverse Event
Malfunction ·BAYER HEALTHCARE, LLC·Product code NBW·May 22, 2008

ARTERIAL CANNULA 20G/45MM

FDA Adverse Event
Malfunction ·Product code FOZ·July 15, 2021

TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code JEY·March 3, 2017

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

Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018