16 results · 29ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113257·VITRECTOMY KNIFE 25GA (BX/5)

Finebeam

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CoRoent

FDA UDI
Nuvasive, Inc.·00887517568694·CoRoent Ant TLIF Ti, 10x12x28mm 8°

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113226·VITRECTOMY KNIFE 20GA (BX/5)

Ophthalmic Knife

FDA UDI
KATENA PRODUCTS, INC.·00841668113233·VITRECTOMY KNIFE 19GA (BX/5)

ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER

FDA 510(k)
FDA Class 2 ·Anesthesiology

COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

FDA 510(k)
FDA Class 2 ·Immunology

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

ALARIS PUMP MODULE

FDA Adverse Event
Death ·CAREFUSION CORP.·Product code FRN·June 27, 2013

SELECT SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

FDA Adverse Event
Injury ·ETHICON INC.·Product code GAW·March 1, 2024

PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR·Product code MGB·March 29, 2024

ALINITY I B12 REAGENT KIT

FDA Adverse Event
Malfunction ·A.I.D.D LONGFORD·Product code CDD·March 29, 2022

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

paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024