14 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814558·GENUMEDI SAND SIZE IV
Hemostat Forceps
FDA UDI
Medetz Surgical Instruments LLC·G2231128040·Hartmann mosquito forceps, 3 3/4", straight 20m...
T-Crystal cartridges Standard Pink
FDA UDI
PERFLEX LTD·07290110506247·5 identical cartridges sealed in a vacuum bag ;...
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS
FDA 510(k)
FDA Class 2
·Neurology
SPI TITANIUM BASE FOR CAD/CAM
FDA 510(k)
FDA Class 2
·Dental
NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·June 10, 2024
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 14, 2013
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 18, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
HA Hip Stem, cementless
FDA Recall
Terminated
·Product code JDI·June 30, 2004
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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025