66 results
·
27ms
·
Sources: EU EUDAMED, US FDA
FOCUS RADIATION TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·00843717100065·Temporary Crown & Bridge Material Shade A3
Needle Guide
FDA UDI
QUANTUM SURGICAL·03760305400062·The Needle Guide is an instrument of the EPIONE...
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036018764·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776363239·Jeter Pharyngeal Dissector
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100270·Assembly, Caddie, Large Cervical Implants, Hinged
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100270·Tray Insert Iliac Screws 12 x 12 Assembly
Kalitec Disc Prep
FDA UDI
Kalitec Direct LLC·BO73DRK0100270·Rasp, Angled Lumbar
A8 INTEGR8® Porous Pedicle Screw System
FDA UDI
ALLUMIN8, INC.·00850080774014·Tulip Alignment Tool
PC
FDA UDI
Allied Medical, LLC·00026072012314·COUPLER CMPD SAFETY KEYED
WIRE DRIVER & FIXATION DRILL
FDA Adverse Event
Malfunction
·LINVATEC CORP.·Product code HTW·December 22, 2005
MAXIM KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
INSUFFLATION NEEDLE, MODEL R65-933
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS
DELTA CERAMIC FEM HD 36/-3MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·July 31, 2017
TPRLC 133 FP TYPE1 BM SO 10.0
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 31, 2017
G7 BONEMASTER LTD ACET SHL 52E
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·July 31, 2017
GOBED II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·March 25, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·March 9, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NEK·March 27, 2008