17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWDER FREE NITRILE EXAMINATION GLOVES, BLACK
FDA 510(k)
FDA Class 1
·General Hospital
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252598213·S-DRILLING TAP, HEX, FOR 8/10mm SCREW
ANS AXXESS PERCUTANEOUS LEAD
FDA 510(k)
FDA Class 2
·Neurology
MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
1049092-2018-00287
FDA Adverse Event
Injury
·Product code FRO·May 15, 2018
9618003-2021-01239
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
AMPLATZER VASCULAR PLUG II
FDA Adverse Event
Injury
·AGA MEDICAL CORPORATION·Product code KRD·May 3, 2013
QC F/DHS/DCS TRIPLE REAMERS F/TRS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·September 16, 2014
UV FLASH TRANSFER SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 18, 2011
Dressing, wound, drug
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·September 9, 2021
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Injury
·CONCENTRIC MEDICAL·Product code NRY·December 14, 2012
9618003-2021-01006
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·May 28, 2021
9618003-2021-01210
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·July 15, 2021
INNOVA 3100-IQ
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS SCS·Product code OWB·May 30, 2017
Dressing, wound, drug
FDA Adverse Event
Malfunction
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·October 17, 2022
9618003-2022-00003
FDA Adverse Event
Injury
·CONVATEC DOMINICAN REPUBLIC INC·Product code FRO·January 6, 2022
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016