15 results · 20ms · 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.

CEDIA DAU LSD ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Zuma

FDA UDI
Seaspine Orthopedics Corporation·10889981097455·Modular Bullet Paddle Distractor 14mm

LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

SEX CRIMES/SEX ASSAULT VICT/SUSPECT EVID COLL KITS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

PARADIGM REAL-TIME INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·February 11, 2013

TENDRIL DX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Death ·BAXTER HEALTHCARE·Product code KDJ·July 24, 2014

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·May 19, 2020

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·April 21, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·November 23, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·October 31, 2017

ESSURE

FDA Adverse Event
Injury ·BAYER PHARMA AG·Product code HHS·May 24, 2016

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024