27 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEOCARE 20 MICRON BLOOD FILTER
FDA 510(k)
FDA Class 2
·General Hospital
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
FDA 510(k)
FDA Class 1
·General Hospital
HEARTSTART ONSITE
FDA Adverse Event
Death
·PHILIPS NORTH AMERICA LLC·Product code MKJ·May 5, 2021
PROXIMATE RELOADABLE LINEAR CUTTER WITH SAFETY LOCK-OUT
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GAG·March 22, 2006
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 3.5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.·Product code KOG·June 16, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC. (CINCINNATI)·Product code GDW·June 13, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GCJ·June 19, 2006
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GCJ·June 8, 2006
45MM ARTICING LNR CUTR/BLUE RLD
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.·Product code GCJ·December 21, 2005
ENDO LINEAR CUTTERS-ETS45MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·June 8, 2006
ENDOPATH ETS-FLEX45 ARTICULATING ENDOSCOPIC LINEAR
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 15, 2006
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·December 30, 2015
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 1, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 1, 2011
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM -
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·October 21, 2005
ETS 45 ENDO LINEAR CUTTER BL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code KOG·December 19, 2005
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDICS·Product code KWP·May 15, 2013