20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
FDA 510(k)
FDA Class 2
·Neurology
HELICAL BLADE INSERTER
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·October 3, 2018
LAGUNA PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
SLIDING MECHANISM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTD·July 5, 2021
SLIDING MECHANISM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HTD·January 17, 2017
SLIDING MECHANISM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HTD·August 16, 2016
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·April 13, 2022
SLIDING MECHANISM
FDA Adverse Event
Malfunction
·SYNTHES SELZACH·Product code HTD·June 10, 2016
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·May 24, 2013
UNIFY CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·September 30, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·April 20, 2021
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·April 20, 2021
GALAXY G3 MINI 2MM X 6CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 4, 2021
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 4, 2021
GALAXY G3 MINI 1MM X 4CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·August 30, 2022
SLIDING MECHANISM
FDA Adverse Event
Injury
·SYNTHES SELZACH·Product code HTD·March 24, 2016
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
FDA Enforcement
Class II
·Terminated·Senseonics, Inc.·November 6, 2019
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018