27 results · 21ms · Sources: EU EUDAMED, US FDA

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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