29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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