10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
Printed Lower Crown Pack for Herbst LL4 14mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199016250·
Stern EX Acid Etched Implant RP 3.75x18.0mm, DD, Biomain, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108662·The Sterngold Acid Etch Dental Implant System c...
Vu a POD Prime NanoMetalene
FDA UDI
Seaspine Orthopedics Corporation·10889981159641·Prime NM Implant, 39x30mm x 16mm, 25 Deg
PRONOVA NONABSORBABLE SUTURE, USP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EPICARE-DUO LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HEARTSTART ONSITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 7, 2014
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS INC·Product code LYJ·November 12, 2010
UNKNOWN STEM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·January 3, 2013
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·April 10, 2019