22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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