38 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS
FDA 510(k)
FDA Class 2
·General Hospital
IMMCO DIAGNOSTICS
FDA UDI
IMMCO DIAGNOSTICS, INC.·00845714002007·Hep-2 Cells -Anti-Nuclear Antibody IFA Kit
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948038774·DURAVENT LINGO-PHON 1 IC + 1 ICF, SIZE 10
PIERMATTEI SHOULDER ELEVATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090958·PIERMATTEI SHOULDER ELEVATOR SINGLE ENDED
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132100·Trial, TLIF, 27L OB CRV 7Deg, 10mm
AO
FDA UDI
STRYKER CORPORATION·04546540216472·3.25:1 Large Reamer
TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
FDA 510(k)
FDA Class 2
·Orthopedic
TRUWAVE
FDA 510(k)
FDA Class 2
·Neurology
Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
FDA 510(k)
FDA Class 2
·Cardiovascular
AVEA VENTILATOR
FDA Adverse Event
Malfunction
·CAREFUSION·Product code CBK·July 17, 2015
COMP SRS NEXEL 70MM DST BDY LT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026
COMPR SRS TUMOR BDY - 71MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026
COMPR SRS IC SEG - 30MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026
COMPR SRS MOD RGX AUG - LG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·May 22, 2026
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 25, 2011
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
FDA Adverse Event
Injury
·MEDTTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·August 8, 2008
CADWELL
FDA Adverse Event
Injury
·TECHNOMED EUROPE·Product code GXZ·April 1, 2026