10 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
3M™ Forsus™
FDA UDI
3M UNITEK CORPORATION·00652221139214·3M™ Forsus™ Fatigue Resistant Device, 885-149, ...
COMPUTING SPECTROPHOTOMETER BIO-CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PERIDONTAL SCALING SOLUTION-B
FDA 510(k)
FDA Class 1
·Dental
DRILL, AO, STERILE ?4, 2X340MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 10, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 19, 2014
LPS 24MM DIAPHYSEAL SLEEVE
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code MBH·October 22, 2010
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 26, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar Forceps/Reusable, Model #41604, 510 (k) #K885199. The surgical device is package in non-sterile small plastic tubes. Monopolar Reusable Forceps - are intended for use in cutting and coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012