18 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HARDY DISK, CEFPODOXINE, 10MCG
FDA 510(k)
FDA Class 2
·Microbiology
Procure
FDA UDI
Twin Med, LLC·10840330700730·Trach Tie Pediatric/Neonatal, 2 Piece, 100% hyp...
SCANLAN® Needle Holders
FDA UDI
SCANLAN INTERNATIONAL INC·00846159019438·Jacobson Needle Holder
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981196042·Poly. Screw, 3.5mm x 32mm
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386026123·Smooth shank screw, Ø 3.5mm, length 32mm, high ...
C6-2Gs Ultrasonic Transducer(FDA)
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088341·
QUATTRODE LEAD WIDE SPACED, 90 CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZF·July 9, 2016
JEL 15
FDA 510(k)
FDA Class 2
·Dental
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HAND PIECE FOR BATTERY POWERED DRIVER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HWE·October 18, 2024
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO.·Product code IRT·February 11, 2013
ACCU-VU ANGIOGRAPHIC CATHETER
FDA Adverse Event
Malfunction
·ANGIODYNAMICS, INC.·Product code DQO·February 18, 2011
LIFECARE PCA PLUS INFUSER
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code FRN·February 26, 2008
E-LUMINEXX BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·November 17, 2015
E-LUMINEXX BILIARY STENT
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK KG·Product code FGE·August 16, 2016
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025