299 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ArgenZ HT+ 98x12 B3
FDA UDI
ARGEN CORPORATION, THE·D818121998·Dental porcelain/ceramic restoration kit
Sleepware
FDA UDI
Respironics, Inc.·00606959046955·Software, Sleepware G3 (Japan Only)
Sleepware
FDA UDI
Respironics, Inc.·00606959038943·Sleepware G3 Software Package, Japan
KAIYANG ALUMINUM WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
HORIZONS CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOFTFORM FACIAL IMPLANT
FDA Adverse Event
Injury
·TISSUE TECHNOLOGIES, INC.·Product code FTL·December 29, 1998
INTRA-AORTIC BALLOON CATHETER
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·January 12, 1998
SOFTFORM FACIAL IMPLANT
FDA Adverse Event
Injury
·TISSUE TECHNOLOGIES, INC.·Product code FTL·December 29, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Injury
·DATASCOPE CORP·Product code DSP·January 28, 1998
STAL DL 9.5 FR. 34 CC. IAB
FDA Adverse Event
Malfunction
·DATASCOPE CORP·Product code DSP·May 14, 1998
STAT DL 9.5 FR. 40 CC. IAB
FDA Adverse Event
Death
·DATASCOPE CORP.·Product code DSP·February 23, 1998
RESTORE 6X10 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 11, 1998
RESTORE 5X10 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 11, 1998
ARTIFICIAL URINARY SPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code EZY·June 11, 1997
MASTERS SERIES ROTATABLE VALVE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.·Product code LWQ·June 28, 2002
RESTORE 4X13 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 11, 1998
RESTORE 5X13 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 11, 1998
RESTORE 4X10 SELF-TAPPING IMPLANT WITH MOUNT
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·November 11, 1998
SUSTAIN 3.75X10 HA SCREW
FDA Adverse Event
Injury
·LIFECORE BIOMEDICAL, INC.·Product code DZE·May 12, 1998