16 results
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19ms
·
Sources: EU EUDAMED, US FDA
SANDBOX I, SANDBOX II, SANDBOX JR.
FDA 510(k)
FDA Class 2
·Physical Medicine
Brigade
FDA UDI
Nuvasive, Inc.·00887517961341·Brigade Lateral Trial, 8x34x24mm 12°
Nexxis OR
FDA UDI
Barco NV·05415334002630·MNA-420 ENC SDI
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228849·Needle, light cve, dull, 6 1/2"
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA, GREEN COLOR
FDA 510(k)
FDA Class 1
·General Hospital
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
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·June 30, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 12, 2010
2600
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
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
HARMONIC SCALPEL HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 26, 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