17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RadGil2
FDA 510(k)
FDA Unclassified
·Unknown
Halliburton - 10 Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588081779·Halliburton - 10 Metal
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10
ANTERIOR CONDYLAR RET 60 DEG
FDA UDI
W.H. Holden, Inc.·D9282011770·
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
FDA 510(k)
FDA Class 1
·Microbiology
APEXNRG RIDER
FDA 510(k)
FDA Unclassified
·Unknown
ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025
DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·December 4, 2015
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 16, 2015
ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·January 20, 2023
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·July 29, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Death
·MEDTRONIC MINIMED·Product code OYC·October 27, 2014
TRIMA ACCEL
FDA Adverse Event
Malfunction
·TERUMO BCT·Product code GKT·July 2, 2013
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
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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