20 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESORB-X G
FDA 510(k)
FDA Class 2
·Neurology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813865·GENUMEDI PRO SILVER SIZE VI
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321216060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311216060·
NIOX
FDA UDI
Circassia AB·07350047030380·The NO sensor for NIOX VERO utilizes analytical...
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MICROMED PD-8K INSULATION DEFECT DETECTOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VACUTRON
FDA UDI
Allied Medical, LLC·00026072004258·SURGICAL SUCTION REGULATOR
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G81711325121606·Osteotomy Wedge System, Cotton Trial 12W x 16D ...
SiNAPTIC Osteotomy Wedge System
FDA UDI
SINTX Technologies, Inc.·G817S111121606·Cotton Wedge, 12W x 16D x 6H
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2021
Ascendant
FDA UDI
Choice Spine, LP·10885862261045·
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·May 16, 2013
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 26, 2014
AML LG STATURE 13.5MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 2, 2011
INCLUSIVE TAPERED IMPLANT
FDA Adverse Event
Malfunction
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 17, 2018
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·March 10, 2022
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·March 8, 2022
Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. Catalog No. 38950-02J2, 300 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
FDA Recall
Terminated
·Boston Scientific·Product code DQX·May 30, 2006
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