15 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ROZINN 151
FDA 510(k)
FDA Class 2
·Cardiovascular
Brigade
FDA UDI
Nuvasive, Inc.·00887517961440·Brigade Lateral Trial, 9x34x24mm 15°
Nexxis OR
FDA UDI
Barco NV·05415334026827·MNA-420 DEC HDMI V2
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228948·Pick,1mm point ang 90deg, med, 6 3/8"
QWH-149 WRIST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
SR PHONARES NHC
FDA 510(k)
FDA Class 2
·Dental
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·August 15, 2025
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NTE·June 30, 2014
DARWIN CR/SB PS TB IN 10M/SZ 4
FDA Adverse Event
Injury
·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code JWH·November 16, 2010
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 14, 2012
Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.
FDA Enforcement
Class II
·Terminated·TELEFLEX MEDICAL INC·August 5, 2020
SYRINGE 10ML LS 21X1-1/2 AN EMERALD
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·August 2, 2019
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 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