13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OsseOne Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
AVANOS
FDA UDI
Avanos Medical, Inc.·00193493934836·AVANOS* Single-Shot Epidural Trays
Halyard
FDA UDI
Avanos Medical, Inc.·10680651934830·HYH,EP TRY,S-SHOT,-,-,10
SURGVIEW INTEGRATED VISUALIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CALIBER SPACER
FDA 510(k)
FDA Class 2
·Orthopedic
REVERSE SHOULDER SYSTEM GLENOID POLYAXIAL LOCKING SCREW L26
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PHX·March 8, 2019
COBALT G-HV BONE CEMENT 40G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·April 19, 2021
INTELLIVUE MULTI MEASUREMENT SERVER X2
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MHX·June 10, 2013
STRYKER ENDOSCOPY
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY·Product code HRX·July 25, 2011
*
FDA Adverse Event
BOSTON SCIENTIFIC·Product code LWS·September 17, 2008
COBALT G-HV BONE CEMENT 40G
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LOD·October 28, 2020
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
FDA Enforcement
Class II
·Terminated·Kimberly-Clark Corporation·December 25, 2013
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018