14 results · 22ms · 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.

TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM

FDA 510(k)
FDA Class 2 ·Neurology

UNIVERSAL THREAD

FDA UDI
FGX INTERNATIONAL INC.·00193033575017·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0100410·Caddie Lid, Curved Rods

UNIVERSAL THREAD

FDA UDI
FGX INTERNATIONAL INC.·00196365849054·

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0140010·T-Handle, T30 Split Tip Cap Starter

NIDO Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07315K0140400·Driver Shaft, T30 Final Cap Driver

Kalitec Disc Prep

FDA UDI
Kalitec Direct LLC·B07319K0160410·Curette, Left Angle, #5

SLT DIFFUSER FIBER

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

FREELITE KAPPA FREE KIT

FDA 510(k)
FDA Class 2 ·Immunology

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

INTEGRITY AFX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2011

SPACEMAKER BLUNT TIP TROCAR 10MM

FDA Adverse Event
Malfunction ·PONCE - USS·Product code GCJ·March 14, 2008

WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

FDA Enforcement
Class II ·Terminated·CooperSurgical, Inc.·April 22, 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