18 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
DIAPHYSARY TRIAL SHAFT ESOP DIAMETER 9
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489017728·
HHM
FDA UDI
Oticon A/S·05707131354808·G500 SC, MINIRITE 312 2.4G C044 HHM
6450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136025315·DV2 MED MASK HG AEROGEN MA 50A
NA
FDA UDI
Synthes GmbH·10886982142795·2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE R...
CODMAN
FDA UDI
Cerenovus, Inc.·10886704002130·CODMAN SLIM-LINE Aneurysm Clip Graft 5mm Diamet...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF2017720·2.4mm Cortex Screw, T8 Stardrive, Self-Tapping,...
LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
FDA 510(k)
FDA Class 2
·Ophthalmic
TSRH(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ALARIS PUMP MODULE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION·Product code FPA·October 7, 2016
RAD-G
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·July 21, 2022
MYXO ETLOGIX RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·October 15, 2008
840 VENTILATOR
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·June 28, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 5, 2011
OMNIPOD 5 CONTROLLER
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code QFG·August 22, 2022
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