26 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clave Neutral-Displacement Needlefree Connectors
FDA 510(k)
FDA Class 2
·General Hospital
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250616200·ceraMotion® Zr 3D Dentin CC3+2, 20 g / dental c...
IMP,TSV,4.1,13,MTX,MG
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·June 13, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 1, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 1, 2025
Trevo XP ProVue Retriever (4x30mm)
FDA 510(k)
FDA Class 2
·Cardiovascular
21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB
FDA 510(k)
FDA Class 2
·Radiology
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·16975384337145·6 pieces
KP
FDA UDI
Guilin Kevin Peter Technology Co., Ltd.·06975384337148·6 pieces
HS HAND CONTROLLED CURVED SHEA
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GEI·November 14, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 9, 2011
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC·Product code CBK·July 26, 2013
TREVO XP PROVUE 4MM X 30MM
FDA Adverse Event
Injury
·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020
Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
FDA Enforcement
Class I
·Ongoing·Percussionaire Corporation·October 22, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 90, REF E NRT-06090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025
NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.
FDA Enforcement
Class II
·Completed·Applied Medical Technology Inc·October 15, 2025
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020