15 results
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19ms
·
Sources: EU EUDAMED, US FDA
ACL TOP 700 LAS
FDA 510(k)
FDA Class 2
·Hematology
Symmetry Sachs
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482053256·Symmetry® Suction Tube; Sachs; w/Finger Valve A...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450679326·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450226094·
11G BLADED MAMMOTOME ST PROBE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code KNW·February 27, 2006
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
FDA 510(k)
FDA Class 2
·Cardiovascular
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
FDA 510(k)
FDA Class 2
·Neurology
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 24, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 13, 2026
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 3, 2013
LAMITRODE 44
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·August 27, 2014
DA VINCI S SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL,INC.·Product code NAY·May 18, 2011
SYNCHROMED III
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·July 16, 2025
BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
FDA Enforcement
Class II
·Ongoing·Becton Dickinson & Co.·February 14, 2024
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