20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CREATINE KINASE-MB (CK-MB) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TraumaOne SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00888233001489·
TRAUMAONE SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036181055·
Matira
FDA UDI
Kalitec Direct LLC·B07307K0157090·Trial Drill Guide Tube, 9mm
55MM LFT STANDARD MAND
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·January 31, 2021
WEEVAC TC HAND CARRIED RESCUE STRETCHER
FDA 510(k)
FDA Class 1
·General Hospital
BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT
FDA 510(k)
FDA Class 2
·Hematology
ZIMMER BIOMET OMNIMAX SD XD SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code DZL·December 12, 2017
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·June 17, 2025
TOTAL ASR ACET IMP SIZE 60
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·January 15, 2013
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORP·Product code MKJ·November 18, 2010
VERTEX® RECONSTRUCTION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK·Product code KWP·July 7, 2014
APTIMA COMBO 2 ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code LSL·May 30, 2025
TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code DZL·May 20, 2022
TRAUMAONE SYSTEM OMNIMAX SD XD SCREW 2.0X9MM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code DZL·May 20, 2022
OMNIMAX ARCH BAR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·December 12, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017