16 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
FDA 510(k)
FDA Class 2
·Orthopedic
MEDLINE
FDA UDI
MEDLINE INDUSTRIES, INC.·10889942126217·BANDAGE ESMARK 6LTX SFE PACK
ArgenZ HT+ 98x20 B1
FDA UDI
ARGEN CORPORATION, THE·D818122059·Dental porcelain/ceramic restoration kit
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·August 14, 2015
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970379·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970010·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970027·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970492·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970485·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172974018·UniTip High Resolution Catheter 10F
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROVASIVE PULMONARY GUIDEWIRE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·May 21, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM
FDA Adverse Event
Malfunction
·ALLERGAN·Product code LTI·May 24, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 14, 2008
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014