8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ENRICHED CULTURE MED. FLUID THIOGLYC0
FDA 510(k)
FDA Class 1
·Microbiology
DRX-EVOLUTION
FDA 510(k)
FDA Class 2
·Radiology
INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 30, 2014
UNK - ROD
FDA Adverse Event
Injury
·Product code KWP·November 21, 2012
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·September 21, 2010
PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026