13 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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3D ENDOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
FDA 510(k)
FDA Class 2
·Microbiology
MINIMED SILHOUETTE
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·May 16, 2025
NA
FDA UDI
Zimmer, Inc.·00889024065536·
BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·April 10, 2019
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·March 13, 2013
COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 28, 2011
PRISM 2000 GAMMA CAMERA
FDA Adverse Event
Other
·PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.·Product code IYX·February 8, 2008
24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·June 5, 2019
BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·May 16, 2019
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
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
FDA Enforcement
Class II
·Ongoing·Covidien·August 28, 2024