15 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNERMED CALCIUM REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYRINGE 50ML LL
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·February 27, 2020
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
FDA 510(k)
FDA Class 1
·General Hospital
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
FDA 510(k)
FDA Class 2
·Microbiology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
CONSMA·Product code ITJ·June 30, 2014
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·January 2, 2013
X7000 XENON LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·November 12, 2010
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
BD FACSCOUNT INSTRUMENT SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·October 30, 2020
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code KNS·August 11, 2016
UNKNOWN
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code KNS·October 21, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 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