15 results · 25ms · Sources: EU EUDAMED, US FDA

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DIGI-LITE TCD DEVICE

FDA 510(k)
FDA Class 2 ·Radiology

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496062578·APHRODITE 70 GLITTER, SIZE XL, NERO, GRADUATED ...

AXILLARY ACCESS ARTERIAL CANNULA

FDA 510(k)
FDA Class 2 ·Cardiovascular

REPROCESSED ENDOSCOPIC TROCAR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

UNKNOWN TISSUE EXPANDER

FDA Adverse Event
Injury ·MENTOR TEXAS·Product code LCJ·March 10, 2026

CD HORIZON® SPINAL SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 3, 2013

LOW PROFILE CROSSLINK SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 30, 2015

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·March 16, 2013

CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code KRH·June 17, 2008

PREMIUM SURGICLIP S-9.0 TITANIUM

FDA Adverse Event
Injury ·USSC PUERTO RICO, INC.·Product code FZP·April 8, 2011

BD VACUTAINER BLOOD TRANSFER DEVICE WITH LUER ADAPTER

FDA Adverse Event
Injury ·BD CARIBE LTD.·Product code FMI·September 12, 2017

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

FDA 510(k)
FDA Class 2 ·Neurology

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

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018