21 results
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22ms
·
Sources: EU EUDAMED, US FDA
SABRE BT BLUNT0TIP SURGICAL TROCAR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PE anti-human CD4
FDA UDI
BIOLEGEND, INC.·00810034700599·URL: https://www.biolegend.com/en-us/products/p...
Life Instruments
FDA UDI
Life Instrument Corporation·M930798080410·Frazier Suction Tube 4FR, 7" from bend
BUSSE PLASTIC LOR SYRINGE
FDA 510(k)
FDA Class 2
·Anesthesiology
HYGIENIC ANCHORINGS
FDA 510(k)
FDA Class 1
·Dental
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·February 21, 2013
DARCO(R) LOCKING SCREW
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HRS·February 7, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
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