12 results
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15ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy.
FDA Recall
Terminated
·Volk Optical Inc·Product code HKS·June 30, 2008
Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN SET, 15DRP, 1 INJECT PORT,, Model Number: DYNDTB1530; 5) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 6, Model Number: DYNDTB1539; 6) DBD-IV ADMIN SET, 15DRP, 3 NF, 109, Model Number: DYNDTB1545; 7) IV ADMIN SET, 20DRP, 3 NF, 109, Model Number: DYNDTB2045; 8) DBD-IVADMINSET60DRP2NEEDLE-FREEVLVE96, Model Number: DYNDTB0512; 9) DBD-IVADMINSET,60DRP3 NEEDLE-FREE VLVE11, Model Number: DYNDTB0555; 10) IV ADMIN SET, 10DRP, NF,INJ, 96, Model Number: DYNDTB1022; 11) DBD-IV ADMIN SET, 15DRP, 2NF, 96, Model Number: DYNDTB1512; 12) DBD-IV ADMIN SET, 15DRP, 1NF, 92, Model Number: DYNDTB1529; 13) DBD-IV ADMIN SET, 15DRP, ROLLER CLAMP, 9, Model Number: DYNDTB1537; 14) DBD-IV ADMIN SET, 15DRP, SECOND, 40, Model Number: DYNDTB1540; 15) IV ADMIN SET, 20DRP, 1NF, 92, Model Number: DYNDTB2029; 16) DBD-IV EXT SET, 6.5, 1.1ML, M LUERLOCK,, Model Number: DYNDTB5077; 17) IV ADMIN SET, 10DRP, 3 NF, 109, Model Number: DYNDTB1045; 18) DBD-IVADMISET15DRP4NEEDLEFREE VLVESTPCK1, Model Number: DYNDTB1545D; 19) IV ADMIN SET15DRPFLWCTRL1NEEDLEFREE VA, Model Number: DYNDTB2524; 20) IV ADMIN SET, 10DRP, 2NF, 96, Model Number: DYNDTB1012; 21) IV ADMIN SET, 20DRP, 2NF, 96, Model Number: DYNDTB2012; 22) IV ADMIN SET, 20DRP, NF,INJ, 96, Model Number: DYNDTB2022; 23) DBD-IV EXT SET,SMBORE EXT,8,M LUERLOCK,1, Model Number: DYNDTB5081
FDA Recall
Open, Classified
·Product code FPA·December 31, 2025
Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.
FDA Recall
Terminated
·Animas Corporation·Product code LZG·July 29, 2011
LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 4mm connector, 1 X REF: EL-200-4 and 10 X REF: EL-200-4, Manufactured by LiNA Medical ApS, Surgery Division.
FDA Recall
Terminated
·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009
LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Small loop, 8mm connector, 1 X REF: EL-160-8 and 10 X REF: EL-160-8, Manufactured by LiNA Medical ApS, Surgery Division.
FDA Recall
Terminated
·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
FDA Recall
Terminated
·OraSure Technologies, Inc.·Product code LAF·February 5, 2021
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISMUS SCISS STR4.5"CS/25, Model Number 96-2542M; eye surgery
FDA Recall
Open, Classified
·Sklar Instruments·Product code HNF·December 3, 2024
Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290). For use in endoscopic surgery. For use when a rigid endoscopic instrument for grasping and/or dissecting if soft tissue is determined to be appropriate by the surgeon. Monopolar electrosurgical current can be used for coagulation and/or cutting.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code KNF·February 12, 2013
LiNA Loop Endoscopic Monopolar Loop for LSH (Laparoscopic Supracervical Hysterectomy). Large loop, 8mm connector, 1 X REF: EL-200-8 and 10 X REF: EL-200-8, Manufactured by LiNA Medical ApS, Surgery Division.
FDA Recall
Terminated
·LINA Medical ApS Formervangen 5 Glostrup Denmark·Product code KNF·December 1, 2009
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
FDA Recall
Terminated
·Integra Limited·Product code KNF·May 23, 2012
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
FDA Recall
Open, Classified
·MicroSurgical Technology Inc·Product code HNF·September 17, 2024
Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. Catalog Numbers: PC4180933, SSR181128, CPL100252, PC4181647, SSR181640, CPL100404, DFS100254, SSR181230, CPL100406, DFS100410, DPL100206, SRC141230, CRC140304, DFS100716, CRC140406, CPL100203, DFS100204, DPL100408, SSR100253, PC4181240, DPL100202, CDF100408, PC4181137, CSP100500, CDF100154, PC4180830, CSP100350, DFS100152, SRC140408, PC4181034, CPL100206, CDF100152, SRC141025, SRC140225, CPL100304, CRC141025, CPL 100254, PC4181447, DPL100252, DFS100154, SRC140303, DFS100720, DPL 100204, PC4181343, CSP180500, DFS1 0031 0, DPL100306, DPL100256, CPL100306, CDF100304, CDF100203, CDF100410, PC4100412, DPL 100254, DPL 100053, PC41 00626, CDF100208, CRC140306, PC4100517, DFS100203, CSP181400, CPL 100152, DFS100210, CDF100720, CPL100204, CSP180200, DFS100204, CDF100510, DFS101025, DFS100408, PC41 00730, SSR181740, CRC140615, CPL100256, CDF100206, DFS100308, CPL100151, CSP100200, CDF100616, CRC140711, SSR181334, CDF100310, SRC140445, DFS100252, CPL100408, CDF100306, DFS100250, DPL 100152, DPL 100201, CDF100258, SRC140306, CDF100156, DPL 100153, DPL100304, SRC140922, SSR100825, DFS100206, DPL 100203, PC4181550, DFS100616, CSP180900, PC4181950, DFS100406, SRC140717, PC4181750, DFS100925, CSP100400, PC4181846, SRC140711, CPL100153, PC4182050, DFS100306, SRC140406, CSP100900, SRC140615, CDF100308, CSP100300, DFS1 0051 0, CDF100406, CDF1 0021 0, DFS100156, CDF100515, DPL100151, CDF100925, SSR181028, CDF101025, SSR181540, CPL 100201, SSR180825, CPL 100202; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA
FDA Recall
Terminated
·Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131
821 Fox Ln
San Jose CA 95131-1601·Product code HCG·October 21, 2010