16 results
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36ms
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Sources: EU EUDAMED, US FDA
CUI ARTICULATED SILICONE CHIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Brigade
FDA UDI
Nuvasive, Inc.·00887517961402·Brigade Lateral Trial, 14x34x24mm 12°
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228900·Strut Pick, .50mm point ang 90deg, med, 6 1/2"
ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INTCO TAB ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
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
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·June 30, 2014
UNKNOWN DEPUY FEMORAL
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 16, 2010
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 2012
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
HF-RESECTION ELECTRODE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·March 8, 2023
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·August 29, 2024
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
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 8, 2025
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