27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
3D KNEE
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65820201141·Channels Hedstrom Files 21mm
Channels
FDA UDI
HENRY SCHEIN, INC.·10304040037765·Channels Hedstrom Files 21mm, #25
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717101670·Burs FG 1158, Pkg/100
Asnis
FDA UDI
Stryker GmbH·07613154577842·CANNULATED SCREW
Premium Study Kit
FDA UDI
Cleveland Medical Devices Inc.·B14360201141·Single use, premium study kit extra extra large.
VELOX
FDA UDI
SPINECRAFT, LLC·00193082077401·VELOX Four Level Plate Caddy
Novel
FDA UDI
ALPHATEC SPINE, INC.·00811801035487·Bullet-nosed Disc Shavers - 14mm
ITOTAL IDENTITY CR KRS
FDA Adverse Event
Injury
·CONFORMIS·Product code JWH·March 28, 2024
RUBBERCARE GUARDIAN POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVES: CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER
FDA 510(k)
FDA Class 1
·General Hospital
RS-4M+MUSCLE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROATION KNEE
FDA Adverse Event
Injury
·MATORHTO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Malfunction
·MATORTHO LIMITED·Product code JWH·January 22, 2016
MEDIAL ROTATION KNEE
FDA Adverse Event
Injury
·MATORTHO LIMITED·Product code JWH·January 22, 2016
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code LFR·May 25, 2007
FLOGARD
FDA Adverse Event
Malfunction
·SHARP CORPORATION OSAKA JAPAN·Product code FRN·March 25, 2013
ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·March 10, 2011
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·December 24, 2014