18 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Discovery NM/CT 670 CZT
FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768468·GENUMEDI PSS GREEN II
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551057735·BUCK Ear Curette, sharp, size 2
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100318·ALPHONSO INFANT SPECULUM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100288·SAUER PREMATURE INFANT SPECULUM 2MM
Ophthalmic Speculum
FDA UDI
KATENA PRODUCTS, INC.·00841668100363·COOK EYE SPECULUM #2 SOLID
Prime Medical LLC
FDA UDI
Prime Medical LLC·00850055249295·PrimePadPlus-K15-3422
BRK-1
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL CARDIOVASCULAR DIVISION·Product code DRC·February 1, 2024
ELECSYS DHEA-S CALCHECK 5
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOLOHEALTH STATION
FDA 510(k)
FDA Class 2
·Cardiovascular
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., HU·Product code KWP·October 17, 2025
CD HORIZON BALLAST SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NKB·December 9, 2019
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·June 8, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 8, 2014
ENDOVIVE SAFETY PEG KITS PULL METHOD
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KNT·August 21, 2008
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·March 15, 2023
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 9, 2023
ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023