19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MULA (K2-A1)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981215798·No-Profile Interbody, 3-Hole Faceplate 14mm
Holder, Needle, TC, acc. Crile-Wood 26cm
FDA UDI
Geister Medizintechnik GmbH·04057034065624·Holder, Needle, TC, acc. Crile-Wood
26cm ...
TriplePlay
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377021213·FM5 - Grael
HEALICOLL
FDA 510(k)
FDA Unclassified
·Unknown
WARTIE WART REMOVER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ONE TOUCH PROFILE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 2, 2002
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 1, 2024
ABL800 FLEX ANALYZER
FDA Adverse Event
Malfunction
·RADIOMETER MEDICAL APS·Product code CHL·March 25, 2024
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 10, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·September 9, 2011
4MM DIAMOND BALL, 15CM
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBE·July 17, 2013
NAVLOCK
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code OLO·February 3, 2025
SKINTACT
FDA Adverse Event
Malfunction
·LEONHARD LANG GMBH·Product code MKJ·October 17, 2024
BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1. Cortical Screw, Locking; Article Numbers: 37351-10-N, 37351-12-N, 37351-14-N, 37351-16-N, 37351-18-N, 37351-20-N, 37351-22-N, 37351-24-N, 37351-26-N, 37351-28-N, 37351-30-N, 37351-32-N, 37351-34-N, 37351-36-N, 37351-38-N, 37351-40-N, 37351-42-N, 37351-44-N, 37351-46-N, 37351-48-N, 37351-50-N, 37351-55-N, 37351-60-N, 37351-65-N, 37351-70-N, 37351-75-N, 37351-80-N, 37351-85-N. 2. Humeral Plate, Distal; Article Numbers: 21241-5, 21241-7, 21242-7, 21243-10, 21244-9.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020