24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LASER INDIRECT OPHTHALMOSCOPE 500(LIO-500)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021041·5570 3L SYR FUTUREMED NO LABEL
AOS TIBIAL NAIL 13mm x 39.0cm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665016482·
QUICKCLOT
FDA 510(k)
FDA Unclassified
·Unknown
ETG 255 COMBO STIMUALTOR, TEN 260 STIMUALTOR
FDA 510(k)
FDA Class 2
·Neurology
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·September 13, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 6, 2019
ASR ACETABULAR CUPS 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 15, 2013
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTL., LTD.·Product code KWA·May 20, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 3, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 29, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·December 26, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 4, 2020
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·May 31, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·April 7, 2021
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·November 30, 2021
EQUINOXE ANATOMIC SHOULDER COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·May 22, 2025
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·February 26, 2019
Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;
FDA Enforcement
Class II
·Ongoing·Ventec Life Systems, Inc.·June 30, 2021