17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SVED Wound Treatment System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI
G-CATH TISSUE ANCHOR DELIVERY CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WATCH PAT 100S
FDA 510(k)
FDA Class 2
·Anesthesiology
WATCHPAT100
FDA Adverse Event
Injury
·ITAMAR MEDICAL LTD.·Product code MNR·November 12, 2007
FUJIFILM ENDOSCOPE MODELS EC-760R-V/M
FDA Adverse Event
Malfunction
·FUJIFILM CORPORATION·Product code FDF·March 25, 2024
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·May 29, 2013
ECHELON LINEAR CUTTER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 6, 2014
ANCHOR
FDA Adverse Event
Malfunction
·ANCHOR PRODUCTS CO.·Product code GCJ·June 24, 2011
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Injury
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021
PRUITT F3 CAROTID SHUNT
FDA Adverse Event
Malfunction
·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021
PKG, BIOPSY FORCEPS, PUNCH, P/N 0250080290. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020