20 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
Multi-unit Abutments for CONELOG
FDA 510(k)
FDA Class 2
·Dental
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA
RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COMPLETE BRAND MULTI-PURPOSE SOLUTION
FDA 510(k)
FDA Class 2
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2025
GALILEO
FDA Adverse Event
Malfunction
·IMMUCOR·Product code KSZ·April 23, 2009
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO.·Product code IRT·October 9, 2008
SIGMA 100 S
FDA Adverse Event
Injury
·MEDTRONIC OF CANADA LTD.·Product code DXY·August 11, 2011
MECHANICAL CHAIR/TRANSPORT CHAIR
FDA Adverse Event
DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code INM·July 2, 2013
PROXIMAL HUMERUS, RIGHT, ÿ 11X160MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
ANN BLUNT TIP SCREW 4X44MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
ANN BLUNT TIP SCREW 4X46MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HRS·May 13, 2025
UNKNOWN
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
TI LOW PROFILE SCREW 6.5X20MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·April 24, 2014
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·October 10, 2025
ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 18, 2026
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
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021