99 results
·
34ms
·
Sources: EU EUDAMED, US FDA
Single-Use Biopsy Valve (MAJ-1555)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
FDA 510(k)
FDA Class 1
·General Hospital
CAPIOX RX15 HOLLOW, FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
FDA 510(k)
FDA Class 2
·Cardiovascular
VITAL-PORT
FDA Adverse Event
Malfunction
·VITAL-PORT VASCULAR ACCESS·Product code LJT·January 29, 1998
MYOCARDIAL SUTURELESS PERMANENT PACING LEAD
FDA Adverse Event
Other
·DAIG CORP.·Product code DTB·January 7, 1998
RESTORE 5X10 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 4, 1998
UNK
FDA Adverse Event
Injury
·UNK·Product code DZE·January 24, 1998
RESTORE 3.3X15 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·September 11, 1998
RUSSELL-TAYLOR
FDA Adverse Event
Malfunction
·SMITH & NEPHEW, INC. ORTHOPAEDICS DIV.·Product code HWC·October 22, 1998
GENESIS TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW INC. ORTHOPAEDICS DIV.·Product code HSH·June 29, 1998
SOFTFORM FACIAL IMPLANT
FDA Adverse Event
Injury
·TISSUE TECHNOLOGIES, INC.·Product code FTL·November 12, 1998
BIOMET ARCOM PATELLA
FDA Adverse Event
Injury
·BIOMET, INC.·Product code HTG·March 24, 1999
VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code LWS·March 6, 1997
AUTO SUTURE CHEMOSITE TWO-PIECE POLYURETHANE SYSTEM
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL CORP.·Product code LCJ·August 27, 1997
LIFE PAK
FDA Adverse Event
Injury
·PHYSIO-CONTROL CORP.·Product code LDD·July 30, 1997
AUTO SUTURE ROTICULATOR 55-4.8
FDA Adverse Event
Malfunction
·UNITED STATES SURGICAL CORP.·Product code GAG·June 18, 1997
SOFTFORM FACIAL IMPLANT
FDA Adverse Event
Injury
·TISSUE TECHNOLOGIES, INC.·Product code FTL·June 22, 1998
PACER LEADS
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DTB·February 26, 1998
MEDTRONIC
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·January 19, 1998
STAT DL 9.5 FR. 40 CC IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORPORATION·Product code DSP·February 20, 1998