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

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ESOPHAGEAL TTS STENT

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772813858·GENUMEDI PRO SILVER SIZE V

DeRoyal

FDA UDI
DEROYAL INDUSTRIES, INC.·00749756612630·Wrist Splint

TAPERLOC HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304282216·

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

UniTip High Resolution Catheter

FDA UDI
Unisensor AG·07640172970577·

K2M General Instruments

FDA UDI
VB Spine LLC·10888857552036·Rotation Wrench

CLYDESDALE PTC SPINAL SYSTEM

FDA Adverse Event
Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

FDA 510(k)
FDA Class 3 ·Cardiovascular

BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE1/10 MM R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 11, 2019

MECHANICAL WALKER, ROLLATOR

FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·May 21, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 20, 2008

CAPSUREFIX NOVUS MRI

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·June 14, 2011

FITMORE®, HIP STEM, UNCEMENTED, B/7, TAPER 12/14

FDA Adverse Event
Injury ·ZIMMER GMBH·Product code KWY·December 21, 2023

M2A-MAGNUM MOD HD SZ 54MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 11, 2018

M2A-MAGNUM PF CUP 60ODX54ID

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWA·June 11, 2018

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 5, 30.0 mm; Ref 96-0557.

FDA Recall
Terminated ·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020