19 results · 23ms · Sources: EU EUDAMED, US FDA

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Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

FDA 510(k)
FDA Class 2 ·General Hospital

CoRoent

FDA UDI
Nuvasive, Inc.·00887517567000·CoRoent Ant TLIF PEEK, 16x12x30mm 4°

BI-METRIC INTERLOK HIP SYSTEM

FDA UDI
Biomet Orthopedics, LLC·00880304222663·

K162309

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code PGW·November 14, 2019

UniTip Catheter

FDA UDI
Unisensor AG·07640172973547·

BREEZE C MODEL C (3W), BREEZE C (4W)

FDA 510(k)
FDA Class 2 ·Physical Medicine

DLM112 DAYLINK MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 22, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 22, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·September 3, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·January 27, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 12, 2025

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·May 13, 2026

COPELAND HA SZ 2 RESURF HD

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code HSD·June 11, 2013

ASR ACETABULAR CUPS 56

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD·Product code KWA·July 7, 2011

ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 45 MM STAPLE LINE - 3

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 8, 2008

EXPRESS SD RENAL/BILIARY

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FGE·December 11, 2025

C-FLEX MULTI-LENGTH URETERAL STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·January 24, 2020

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·September 21, 2022