14 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PMMA disc
FDA UDI
Dentsply International Inc.·D00180710160·
Imola-Silverstone
FDA UDI
Altus Spine, LLC·00843210133980·SS Paddle Distractor 16mm
BioQuick®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70710161·BioQuick-Bracket FACE Evolution II System .018"...
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193110226·HA PEEK EVOS Curved, , 16mmx10mmx 30mm , BICONV...
General Instrument
FDA UDI
ORTHOPEDIATRICS CORP.·00841132127155·Large Holding Sleeve
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 10, 2024
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DCA VANTAGE ANALYZER
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CGX·April 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·July 2, 2008
ACCOLADE TMZF HIP STEM #4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·April 20, 2011
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012