83 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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Grappler Suture Anchor System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344093·PROTECT.PRO ACTION BACK SUPPORT BLACK S
Instrument kit
FDA UDI
ADLER ORTHO SPA·08054752864122·(K1) KNEE GENERIC INSTRUMENTS
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110279·HALO, 1203-5 VEST PED00, ACRYLIC LINER, 1211-1 ...
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
EASYPOINT NEEDLE
FDA Adverse Event
Injury
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·February 9, 2023
622 - Certi-Gauze Bandage Compress - 2" - 4/Unit
FDA UDI
Certified Safety Manufacturing, Inc.·00766588110028·622 - Certi-Gauze Bandage Compress - 2" - 4/Unit
R1 Reverse Shoulder System
FDA UDI
CATALYST ORTHOSCIENCE INC.·00811596030933·Poly Trail 32mm +4mm
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REPROCESSED ENDOSCOPIC TROCARS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2025
LINOX SMART SD 65/16
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVY·October 29, 2014
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013
LUMAX 540 HF-T
FDA Adverse Event
Death
·BIOTRONIK SE & CO. KG·Product code NIK·November 9, 2015
ASEPT Peritoneal Drainage System, Ref No. P09080002 Product Usage: The pfm medical ASEPT Peritoneal Drainage System is a tunneled, indwelling catheter used to drain accumulated fluid from the abdomen.
FDA Enforcement
Class II
·Terminated·Pfm Medical Inc·December 17, 2014
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·May 22, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 7, 2024
GMK PRIMARY TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 21, 2025
GMK TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·March 3, 2026
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·July 17, 2025