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AUTOTOME RX MODEL # 4515, 4516

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

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·04049958003189·600 micron Holmium Laser Fiber Cable, Reusable,...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540246639·DRILL, WL 14MM, STRYKER-SHAFT

Sim.LED 3500+ 3p CV wCT wCC

FDA UDI
S.I.M.E.O.N. Medical GmbH & Co. KG·04250613832901·Sim.LED 3500+ 3pole Ceiling Version with ceilin...

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464724·

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464717·

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464748·

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464731·

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464694·

SASSY JONES

FDA UDI
FGX INTERNATIONAL INC.·00193033464700·

SOLOBOND PLUS

FDA 510(k)
FDA Class 2 ·Dental

ALANTE, BATTERY OPERATED POWER WHEELCHAIR

FDA 510(k)
FDA Class 2 ·Physical Medicine

INSET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026

INSET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026

INSET

FDA Adverse Event
Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·January 2, 2026

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 6 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·May 3, 2022

NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

FDA Enforcement
Class I ·Terminated·Abbott Vascular·May 24, 2017

NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1013155-12 1013155-15, 1013155-20, 1013156-12, 1013156-15, 1013157-08, 1013157-12, 1013157-15

FDA Recall
Terminated ·Abbott Vascular·Product code LOX·March 22, 2017

PIN COLLET

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·March 20, 2013

SERVO-I

FDA Adverse Event
MAQUET, INC.·Product code CBK·February 28, 2011