9 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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KLS MARTIN HAND PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PRECISION? MONTAGE? MRI
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 2, 2025
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
FDA 510(k)
FDA Class 2
·Hematology
5F GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
KIT GRP A STREP 30 TEST VERITOR
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code GTY·November 22, 2023
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 8, 2013
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
PUMP MMT-512WWP PRDGM INSULIN PL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·May 9, 2008
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024