83 results · 22ms · Sources: EU EUDAMED, 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