10 results
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19ms
·
Sources: EU EUDAMED, US FDA
NOAH MONITORING ELECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Affinity™ Full Arch Technique HF RS sample Kit
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172010252·VPS Impression Material
artegral
FDA UDI
Merz Dental GmbH·D7091970125·anteriors; shade A4; mould BOS
DISPOS-A-CARE THERMOMETER SHEATH
FDA 510(k)
FDA Class 2
·General Hospital
COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION
FDA 510(k)
FDA Class 2
·General Hospital
IMPELLA CP
FDA Adverse Event
Injury
·ABIOMED, INC.·Product code OZD·November 20, 2025
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2013
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·January 14, 2011
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·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