14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KIMGUARD ONE STEP STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
5570 3L SYRINGE
FDA UDI
HANS RUDOLPH, INC.·00817136021850·5570 3L SYR HRI TOURQ CUST ADP
BIO-MODULAR SHOULDER SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304010802·
SYNTHES METALLIC SPIKED WASHERS
FDA 510(k)
FDA Class 2
·Orthopedic
JENSEN ZIRCONIA
FDA 510(k)
FDA Class 2
·Dental
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 16, 2023
EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 11, 2024
EQUINOXE REVERSE 42MM HUMERAL LINER +0
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·June 11, 2024
NITE GUARD
FDA Adverse Event
Malfunction
·RANIR, LLC·Product code OBR·May 1, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·May 15, 2013
MESHGRAFT II DERMATOME WITH RATCHET
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·May 17, 2011
Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001. Distributed outside of the US only).
FDA Recall
Terminated
·Disetronic Medical Systems, Inc.·Product code LZG·March 31, 2006
EMBLEM S-ICD Model A209
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025