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

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CABS'AIR

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

Focal 44 Sublative iD (200 Pulses), 10 Pack

FDA UDI
Candela Corporation·00817495023762·

AVISTA MRI

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 26, 2024

DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

PRESSURE WIRE SENSOR, MODEL 12003/12303

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD LUER LOK SYRINGE

FDA Adverse Event
Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·March 11, 2020

CD HORIZON LEGACY MINI SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS, INC.·Product code MNI·February 3, 2012

IMF SCREW Ø2 L8 SST

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code DZL·April 23, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORP.·Product code LZG·April 13, 2011

CAPSUREFIX NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

FDA Enforcement
Class II ·Terminated·Exactech, Inc.·October 7, 2020

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

Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158

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