25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UNITY Sacroiliac Joint Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
CENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYSTEM
FDA UDI
ORTHOFIX SRL·18032937167838·STABILIZING SLEEVE
FreeStyle LibreLink
FDA UDI
ABBOTT DIABETES CARE INC·00357599000042·FreeStyle LibreLink Android US
AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NARVAL CC
FDA 510(k)
FDA Class 2
·Dental
TRUEPLUS, 0.5 CC 31 GAUGE SYRINGE
FDA Adverse Event
Injury
·TRIVIDIA HEALTH·Product code FMF·January 24, 2017
ACCU-CHEK ADVANTAGE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS CORP.·Product code NBW·May 4, 2005
STEM: MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 6
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 11, 2020
CONSTELLATION VISION SYS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CTR·Product code HQC·October 10, 2014
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 23, 2011
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2013
BD SYRINGE 10ML LL BNS
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code JKA·February 3, 2026
FREESTYLE LIBRELINK
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 31, 2023
FREESTYLE LIBRELINK
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 28, 2023
FREESTYLE LIBRELINK
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 28, 2023
FREESTYLE LIBRELINK
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 31, 2023
FREESTYLE LIBRELINK
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC·Product code PZE·July 31, 2023
6.0MM TI HARD ROD 125MM
FDA Adverse Event
Injury
·WRIGHTS LANE : SYNTHES USA PRODUCTS LLC·Product code MNH·December 12, 2017
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·October 26, 2021
RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is intended for the qualitative and semiquantitative detection of rhematoid factor in human serum. The latex slide test is intended to be used as an aid in the diagnosis of rheumatoid arthritis.
FDA Recall
Terminated
·Product code DHR·February 13, 2018