8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DENTSPLY CAVITRON SPS SCALER SYSTEM
FDA 510(k)
FDA Class 2
·Dental
artegral
FDA UDI
Merz Dental GmbH·D7091970123·anteriors; shade A4; mould BOL
EXERCISE RESPIRATORY GAS ANALYZER
FDA 510(k)
FDA Class 2
·Anesthesiology
TCA 5R / 5S
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2013
SPECTRANETICS LASER SHEATH II
FDA Adverse Event
Injury
·SPECTRANETICS CORPORATION·Product code MFA·January 14, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code UNK·July 31, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021