14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
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