22 results · 21ms · Sources: EU EUDAMED, US FDA

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Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)

FDA 510(k)
FDA Class 1 ·General Hospital

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994235763·PLATE 6190080 ANTERIOR CERVICAL 80MM

ATLANTIS® Anterior Cervical Plate System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000868000·PLATE 6190080 ANTERIOR CERVICAL 80MM

Jawz Endomyocardial Biopsy Forceps

FDA UDI
ARGON MEDICAL DEVICES, INC.·00886333206810·Jawz Endomyocardial Biopsy Forceps 7F x 50cm Pr...

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690196365·AK3 PS Insert Trials - Size 1-5 Pan

ID NOW™ COVID-19 Control Swab Kit

FDA UDI
Alere Scarborough, Inc.·10811877011276·Control Swabs intended for use only with the ID...

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889987169514·CORTICAL SHANK, Cannulated, 9.0 X 80

Mariner Cortical

FDA UDI
Seaspine Orthopedics Corporation·10889981169510·CORTICAL SHANK, Cannulated, 9.0 X 80

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306821721·Laryngeal Mirror #0

APEX Knee System

FDA UDI
Omni Life Science, Inc.·00841690195061·AK3 PS Insert Trials - Size 1-5 Pan Insert

Coral

FDA UDI
Seaspine Orthopedics Corporation·10889981029104·Prebent Rod 5.5 x 80

NA

FDA UDI
STRYKER CORPORATION·07613154613700·3.2mm x 18.3mm Metal Cutting Heliocoidal Rasp

CIRRUS OPEN

FDA 510(k)
FDA Class 2 ·Radiology

REPROCESSED TROCARS, MODEL B5LT AND CB5LT

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

MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET

FDA Adverse Event
Injury ·COOK INC·Product code KNT·November 10, 2021

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 18, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·October 21, 2014

ALARIS PUMP MODULE ADMINISTRATION SET

FDA Adverse Event
Malfunction ·CAREFUSION CORP·Product code FPA·June 29, 2011

EMB FORCEPS (JAWZ)

FDA Adverse Event
Injury ·ARGON MEDICAL DEVICES INC.·Product code KNW·March 7, 2008

SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

FDA Enforcement
Class II ·Terminated·SenTec AG·August 14, 2019