106 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SYPMHONY OCT System
FDA 510(k)
FDA Class 2
·Orthopedic
Echo® Bi-Metric® Hip System
FDA UDI
Biomet Orthopedics, LLC·00887868260452·
ECHO BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304463158·
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193110912·HA PEEK EVOS Rotate, , 14mmx11mmx 26mm , FLAT 1...
OsteoMed
FDA UDI
OSTEOMED LLC·00845694009607·2.0mm x 14mm Cannulated Lag Screw
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776199852·LLETZ PEDS SPEC MD ET
OsteoMed
FDA UDI
OSTEOMED LLC·00845694070201·Cannulated 2.0 x 14mm Lag Screw Sterile Qty 5
SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
TENS STIMULATOR, MODELS 2800 AND 3000
FDA 510(k)
FDA Class 2
·Neurology
SMARTSTITCH PP CONNECTOR
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code NBH·February 7, 2018
SMARTSTITCH PP CONNECTOR
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code NBH·February 8, 2018
SMARTSTITCH PP CONNECTOR
FDA Adverse Event
Malfunction
·ARTHROCARE CORP.·Product code NBH·February 7, 2018
HYLAMER NEUT 48OD X 28ID
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWY·October 6, 2008
DUROM US ACETABULAR COMPONENT 50/44 J
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code KWA·June 20, 2013
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·August 4, 2011
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
M2A-MAGNUM MOD HD SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 9, 2017
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·June 17, 2015
C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016