10 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
FDA 510(k)
FDA Class 1
·Ophthalmic
SOLX 790 TITANIUM SAPPHIRE LASER
FDA 510(k)
FDA Class 2
·Ophthalmic
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 14, 2025
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 27, 2011
VITROS CHEMISTRY PRODUCTS VALP REAGENT
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·September 18, 2008
INTRAUTERINE ACCESS BALLOON CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·December 10, 2020
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022
SELECTIVE SALPINGOGRAPHY CATHETER
FDA Adverse Event
Malfunction
·COOK INC·Product code LKF·November 19, 2021