20 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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EliA SymphonyS Immunoassay
FDA 510(k)
FDA Class 2
·Immunology
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741849·Spratt (Brun) Bone Curette 6-1/2" (16.3cm), siz...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306804885·Robotti Rib Elevator Set (Left and Right)
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101087·HELVESTON "BARBIE" RETRACTOR
Life Instruments
FDA UDI
Life Instrument Corporation·M930719071000·Teardrop Curette Small
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·June 23, 2020
ROLL-X GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
MERCURY CPAP
FDA 510(k)
FDA Class 2
·Anesthesiology
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
I-STAT EC4+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·October 9, 2019
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·September 7, 2020
TRABECULAR METAL PRIMARY HIP PROSTHESIS FEMORAL STEM PRESS-FIT COLLLARLESS
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code KWY·October 6, 2008
MOSAIQ
FDA Adverse Event
Malfunction
·IMPAC MEDICAL SYSTEMS, INC.·Product code IYE·June 24, 2013
TOTALCARE BARIATRIC
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·July 29, 2011
Alinity i TSH Reagent Kit, List Number 07P4830
FDA Enforcement
Class II
·Terminated·Abbott Ireland Diagnostics Division·January 2, 2019
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
GALAXY G3 4MM X 12CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2022