11 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
STILLE Osteotomes
FDA UDI
Stille AB·07332339206574·OSTEOTOME ORIGINAL STILLE 15 mm 21 cm 8.25 in
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0330150·Coronal Bender, Left
MABIS
FDA UDI
D-M-S HOLDINGS, INC.·00767056330153·CALIBER ADJUSTABLE ANEROID SPHYG W/NYLON CUFF B...
ODRC-DYNAMIC HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AXIOM BIOLASER LLLT SERIES-3
FDA 510(k)
FDA Class 2
·Physical Medicine
AMISTEM COLLARED STEM COLLARED HA COATED LAT STEM SIZE2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·July 25, 2018
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·May 24, 2013
IAM : 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·September 29, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·June 17, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021