16 results · 21ms · 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.

BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE

FDA 510(k)
FDA Class 2 ·General Hospital

Implant Prosthetics

FDA UDI
Preat Corporation·00842092103081·CAMLOG® Screw-Line-compatible 4.3mm X 4.5mm Tit...

URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TPN NUTRITION BAG (EVA), EMPTYING TUBE, BAG SYRINGE FILL SET

FDA 510(k)
FDA Class 2 ·General Hospital

MIO ADVANCE

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·July 19, 2024

CERTAIN GOLD-TITE TM HEXED SCREW

FDA Adverse Event
Malfunction ·BIOMET 3I·Product code NHA·June 26, 2017

UNKNOWN_RECONSTRUCTIVE_PRODUCT

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·March 14, 2013

BARD PORT IMPLANTED PORT WITH GROSHONG CATHETER

FDA Adverse Event
Injury ·BARD ACCESS SYSTEMS·Product code LJT·February 21, 2011

COAGUCHEK XS SYSTEM

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 21, 2008

LIGHTSHEER EC

FDA Adverse Event
Injury ·RH USA, INC.·Product code GEX·August 28, 2012

IFS ADVANCED FEMTOSEC LASER

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code GEX·June 9, 2022

CER BIOLOXD OPTION HD 40MM

FDA Adverse Event
Malfunction ·BIOMET UK LTD.·Product code LPH·August 3, 2020

OXF UNI CMNTLS TIB SZ C LM

FDA Adverse Event
Injury ·BIOMET UK LTD.·Product code NRA·August 19, 2021

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022