17 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System
FDA 510(k)
FDA Class 2
·Orthopedic
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082032979·
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032993·
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082006383·
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082032962·
Obturator
FDA UDI
SOPRO-COMEG GmbH·04059082032986·
Obturator
FDA UDI
SOPRO-COMEG GmbH·04059082006390·
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006376·
Arthroscopy sheath
FDA UDI
SOPRO-COMEG GmbH·04059082006406·
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
FDA 510(k)
FDA Class 2
·Hematology
RESPIRONICS PERFORMAX TOTAL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
530G INSULIN PUMP MMT-751LNAS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·September 19, 2018
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 21, 2014
HUTPLUS DR EXT ASSY
FDA Adverse Event
Malfunction
·LIEBEL-FLARSHEIM CO.·Product code KQS·July 19, 2011
28MM DIA COCR MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 26, 2013
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022