19 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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56 SERIES AEROSOL GENERATOR
FDA 510(k)
FDA Class 2
·Anesthesiology
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980074·DeltaForm HD upper posteriors, M, B3 -MADE IN G...
Diazyme Lipoprotein (a) Assay
FDA 510(k)
FDA Class 2
·Immunology
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
FDA 510(k)
FDA Class 2
·Dental
GRANUFLO
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 25, 2014
EON
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 24, 2011
SAFIL UNDYED 5/0 (1) 70CM HR17 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 5, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019
SAFIL VIOLET 2/0 (3) 70CM FR26 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·February 17, 2020
SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019
SAFIL UNDYED 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·October 3, 2019
SAFIL UNDYED 4/0 (1,5) 70CM DS19 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·November 25, 2019
SAFIL VIOLET 5/0 (1) 45CM DS12 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 18, 2019
SAFIL VIOLET 2/0 (3) 70CM DS24 (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·June 4, 2019
SAFIL VIOLET 0(3,5)8X45CM HR40S TO(M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·July 29, 2019
SAFIL VIOLET 1 (4) 70CM HR40S (M)
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAM·December 18, 2019
Angiotech Access Needle. A) Hawkins Blunt Needle. STERILE. Product Number: 216057, 216107, 218057, 218107, 218157. 510k K881957. Qty Dist. - 3,220. B) Winged Guidewire Introducer Needle, Guidewire Introducer Needle, and "WW" Guidewire Introducer Needle. STERILE. Product Number: BGWI1802, BGWI1902, GWI1802, GWI1802WW, GWI1902. GWI1902WW. 510k K974745. Qty Dist: - 51,625. C) Introducer Sheath Needle. STERILE. Product Number: ISN1915. 510k Exempt. Qty Dist: - 1,260. D) Co-Axial Introducer Needle, and Co-Axial Needle - Biopince. STERILE. Product Number: MCXS1408SX, MCXS1409LX, MCXS1410AX, MCXS1410MX, MCXS1410TX, MCXS1412SX, MCXS1415LX, MCXS1416AX, MCXS1609LX, MCXS1610AX, MCXS1610TX, MCXS1612SX, MCXS1615LX, MCXS1616AX, MCXS1616MX, MCXS1616TX, MCXS1808SX, MXCS1809LX, MCXS1810AX, MCXS1810TX, MCXS1812SX, MCXS1815LX, MCXS1816AX, MCXS1816MX, MCXS1816SX, MCXS1816TX, MCXS1820AX, MCXS1820LX, MCXS2009LY, MCXS2010AY, MCXS2010MY, MCXS2010TY, MCXS2012SY, MCXS2015LY, MCXS2016AY, MCXS2016MY, MCXS2016SY, MCXS2016TY, MCXS1610BP, MCXS1615BP, MCXS1810BP, MCXS1815BP, MCXS1820BP. 510k K980004. Qty Dist: - 48,448. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Access Needle
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009