11 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
OPTON PRO
FDA 510(k)
FDA Class 2
·Physical Medicine
Biomet Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304554467·
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515020023·Allen Intestinal Anastomosis Clamp, 1x2 tth, 8"
CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL
FDA 510(k)
FDA Class 2
·Microbiology
Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01
FDA 510(k)
FDA Class 2
·General Hospital
BD ULTRA FINE¿ PEN NEEDLES
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·April 21, 2020
530G INSULIN PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013
STAR TOTAL ANKLE REPLACEMENT
FDA Adverse Event
Injury
·WALDEMAR LINK, GMBH & CO.·Product code NTG·June 16, 2011
PEDIATRIC PULSE OXIMETER C-52 FDA APPROVED
FDA Adverse Event
Malfunction
·BEIJING CHOICE ELECTRONIC TECH. CO., LTD·Product code DQA·July 8, 2010
PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 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