14 results · 22ms · Sources: EU EUDAMED, US FDA

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MODEL SP5107 THERMODILUTION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Intacs Corneal Separator, CW, 0.9mm

FDA UDI
ADDITION TECHNOLOGY, INC.·00850048576001·The Corneal Separators are composed of a stainl...

Intacs Corneal Separator, CCW, 0.9mm

FDA UDI
ADDITION TECHNOLOGY, INC.·00850048576018·The Corneal Separators are composed of a stainl...

HNM MEDICAL

FDA UDI
HNM STAINLESS, LLC.·00812171023463·INTERFERENCE SCISSORSEW, PEEK, 7.0MMX30MM, STER

MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL

FDA 510(k)
FDA Class 2 ·Radiology

MONACO RTP SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

OCTRODE LEAD KIT, 60CM LENGTH

FDA Adverse Event
Injury ·ABBOTT MEDICAL·Product code LGW·October 30, 2023

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 9, 2014

ATTAIN ABILITY

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012

MEDTRONIC

FDA Adverse Event
Injury ·MEDTRONIC, INC.·Product code EZW·August 16, 2010

BIOMET COBALT CHROMIUM CRUCIATE TRAY

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 19, 2017

VANGUARD CRUCIATE RETAINING ILOK FEMORAL

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 19, 2017

BIOMET SERIES A STANDARD PATELLA 31MM X 8.0MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·October 16, 2018

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D, REF 132-22-04; g. ACUMATCH 15 DEGREE LINER 22MM SZ E, REF 132-22-05; h. ACUMATCH 15 DEGREE LINER 22MM SZ F, REF 132-22-06; i. ACUMATCH 15 DEGREE LINER 22MM SZ G, REF 132-22-07; j. ACUMATCH 15 DEGREE LINER 22MM SZ H, REF 132-22-08; k. ACUMATCH 15 DEGREE LINER 28MM SZ E, REF 132-28-05; l. ACUMATCH 15 DEGREE LINER 28MM SZ F, REF 132-28-06; m. ACUMATCH 15 DEGREE LINER 28MM SZ G, REF 132-28-07; n. ACUMATCH 15 DEGREE LINER 28MM SZ H, REF 132-28-08; o. ACUMATCH 15 DEGREE LINER 28MM SZ J, REF 132-28-09; p. ACUMATCH 15 DEGREE LINER 28MM SZ K, REF 132-28-10; q. ACUMATCH 15 DEGREE LINER 32MM SZ G, REF 132-32-07; r. ACUMATCH 15 DEGREE LINER 32MM SZ H, REF 132-32-08; s. ACUMATCH 15 DEGREE LINER 32MM SZ J, REF 132-32-09; t. ACUMATCH 15 DEGREE LINER 32MM SZ K, REF 132-32-10; u. ACUMATCH EXT COV LINER 28MM 46MM, REF 134-28-05; v. ACUMATCH EXT COV LINER 28MM 48MM, REF 134-28-06; w. ACUMATCH EXT COV LINER 28MM 50/52MM, REF 134-28-07; x. ACUMATCH EXT COV LINER 28MM 54/56MM, REF 134-28-08; y. ACUMATCH EXT COV LINER 28MM 58/64MM, REF 134-28-09; z. ACUMATCH EXT COV LINER 28MM 66/70MM, REF 134-28-10; aa. ACUMATCH LAT LINER 28MM 46MM, REF 138-28-05; bb. ACUMATCH LAT LINER 28MM 48MM, REF 138-28-06; cc. ACUMATCH LAT LINER 28MM 50/52MM, REF 138-28-07; dd. ACUMATCH LAT LINER 28MM 54/56MM, REF 138-28-08; ee. ACUMATCH LAT LINER 28MM 58/64MM, REF 138-28-09; ff. ACUMATCH 15 DEG LINER, SZ F, 28MM ID, REF CSK-1663; gg. ACUMATCH 15 DEG LINER, SZ G, 28MM ID, REF CSK-1664; hh. ACUMATCH 15 DEG LINER, SZ H, 28MM ID, REF CSK-1665

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