498 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LANX SPINAL FIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
K121116
FDA UDI
Life Spine, Inc.·00190837016029·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016043·
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837016258·
Z Liquid HT A3-S 100ml
FDA UDI
ARGEN CORPORATION, THE·D818121316·Dental porcelain/ceramic restoration kit
Posterior Column Plate, Right, 6-Hole, PRS Phoenix
FDA UDI
I.T.S. GmbH·09120069818437·
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321213160·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197040662·Super-Cut Kaye Blepharoplasty Scissors
curved...
ZAVATION ROD CONNECTOR
FDA UDI
Zavation LLC·00197157016609·ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 16m...
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AAP CANNULATED SCREWS
FDA 510(k)
FDA Class 2
·Orthopedic
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 23, 2025
GMK-SPHERE PATELLA RESURFACING SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 25, 2024
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T4-I3 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 14, 2019
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025
GMK SPHERE FEMORAL COMPONENT SIZE 4 LEFT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2016
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2021
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·June 10, 2021
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 2, 2025
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 30, 2026