18 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KOBY SURGICAL INTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040064587·MOLAR BAND UR 1ST&2ND 39 (2)
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037312124·GLENOID RESURFACING REAMER Ø36mm WITH DRILL /HU...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0100260·Tray Insert, Lumbar Screw Rack 10 x 10
Intess C
FDA UDI
Kalitec Direct LLC·B07309K0100260·Assembly, Caddie, Implants, Hinged
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710400600260·Anterior Dome Osteotomy Guide, 60mm x 26mm
VIASPAN
FDA Adverse Event
Other
·BARR LABS·Product code KDL·September 10, 2007
EMBOGOLD MICROSPHERE
FDA 510(k)
FDA Class 2
·Neurology
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·November 28, 2022
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 16, 2013
AXSYM DIGOXIN II REAGENT
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.·Product code KXT·June 12, 2008
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 15, 2011
BD FACS 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020
UNKNOWN
FDA Adverse Event
Malfunction
·APPLIED MEDICAL RESOURCES·Product code GCJ·June 8, 2018
BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025
Cook Urological Endoureterotomy Stent, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCF-060026-10-13; GPN REF G18131. Ureteral stent.
FDA Recall
Terminated
·Vance Products Incorporated·Product code FAD·July 31, 2008
Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/26 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060026-10-13; GPN REF G18119. Ureteral stent.
FDA Recall
Terminated
·Vance Products Incorporated·Product code FAD·July 31, 2008