14 results · 25ms · Sources: EU EUDAMED, US FDA

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OW100S (model OW100S-US)

FDA 510(k)
FDA Class 1 ·Physical Medicine

MaXcess

FDA UDI
Nuvasive, Inc.·00887517190703·MaXcess Access Blade, 120mm Center

PILLING

FDA UDI
TELEFLEX INCORPORATED·24026704514841·

Ophthalmic Cannula

FDA UDI
KATENA PRODUCTS, INC.·00841668113875·VISCO INJECTION CANNULA 30GA ANG 10MM

MSI Precision Specialty Instruments

FDA UDI
Med Saver, Inc.·00194613027902·Adson Brown Tissue Forceps, 7 x 7 Teeth, Overal...

Mariner Deformity

FDA UDI
Seaspine Orthopedics Corporation·10889981298395·Iliac Tap, Cannulated, Navigated, 12.0mm

Drive Rail

FDA UDI
ORTHOPEDIATRICS CORP.·00817867020504·Hinge, 12.5 to 20mm

CHF-Y0005

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18

FDA 510(k)
FDA Class 2 ·Neurology

ENSITE CLASSIC SYSTEM

FDA Adverse Event
Injury ·ST. JUDE MEDICAL·Product code DQK·February 9, 2010

COBAS 6000 C501MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·October 23, 2008

ASR UNI FEMORAL IMPL SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

FINELINE II

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVN·July 9, 2013

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