23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112533·BARRON VACUUM TREPHINE 8.5MM
Disposable IV catheter
FDA 510(k)
FDA Class 2
·General Hospital
Golden Isles Pedicle Screw System
FDA UDI
Intelivation, LLC·G079C2522020600·Straight Cobalt Chrome Rod, Extended Hex
VICEROY Spinal System
FDA UDI
EOS BIOTEK,INC.·88000163009320·
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800039826297·Rod Pre-Bent 6.0 x 60mm
Taurus Pedicle Screw System
FDA UDI
SINTX Technologies, Inc.·M555252202060·Taurus Pedicle Screw System- Straight Rod Ext H...
60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·June 26, 2025
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·April 30, 2014
BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·December 4, 2023
OSTEOSYNTHESIS COMPRESSION STAPLE EASYCLIP 10X10X10MM
FDA Adverse Event
Injury
·STRYKER TRAUMA SELZACH·Product code JDR·October 27, 2014
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·August 5, 2011
BIOLOX DELTA HEAD, 12/14, 36 X 0
FDA Adverse Event
Other
·ZIMMER GMBH·Product code LZO·June 20, 2013
LUCIRA CHECK-IT COVID-19 TEST
FDA Adverse Event
Malfunction
·PFIZER, INC.·Product code QJR·August 1, 2023
60" (152 CM) APPX 0.4ML, SMALLBORE EXT SET W/CLAMP, LUER LOCK
FDA Adverse Event
Malfunction
·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FMG·August 5, 2025
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Recall
Terminated
·Surgical Instrument Service And Savings, Inc.·Product code HRH·May 3, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·PFIZER, INC.·Product code QJR·May 8, 2023
Barron Radial Vacuum Trephine (1) Complete Trephine Set 9.0mm Dia. Ref. K20-2062 Lot 122336 Opthalmic
FDA Enforcement
Class II
·Terminated·Surgical Instrument Service And Savings, Inc.·July 10, 2013
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
FDA Recall
Open, Classified
·Linkbio Corp.·Product code HSX·March 21, 2023