22 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MEDIPALM-20
FDA 510(k)
FDA Class 2
·Neurology
IMPACT-20
FDA UDI
Denplus Inc·D8451031202·IMPACT-20, LPL, 2.3 kg
Q-RAD System
FDA UDI
CARESTREAM HEALTH, INC.·60889971031204·Q-RAD SYSTEM/QG-8000-3-R10-T920V
Life Instruments
FDA UDI
Life Instrument Corporation·M930703120200·Optical Holder
CEKA & PRECI-LINE ATTACHMENTS
FDA UDI
Alphadent NV·14260576942118·REVAX M2 SPEC. SPR. PIN 2.02 MM 2 PCS
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0112020·Tap, 4.75mm
MODIFICATION TO BRAIDED GUIDING INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
MSI BIPOLAR SHEATH
FDA 510(k)
FDA Class 2
·Orthopedic
MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017
TRULIANT TIB IMP PSC INSERT SZ 3, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 17, 2024
MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017
UNKNOWN DEPUY BONE CEMENT
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·April 2, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code NIQ·March 22, 2011
HI-TORQUE WHISPER MS GUIDE WIRE
FDA Adverse Event
Injury
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·April 17, 2008
MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017
MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
FDA Adverse Event
Malfunction
·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTL·January 26, 2012
MEDEX¿ CLEAR-CUFF PRESSURE INFUSOR
FDA Adverse Event
Death
·SMITHS MEDICAL ASD, INC.·Product code KZD·June 14, 2017
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
Spirit Plus Bed, A-C Powered Hospital Bed
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·August 10, 2016