29 results · 21ms · Sources: EU EUDAMED, US FDA

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MIXED MEDIA MARKER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814572·GENUMEDI SAND SIZE VI

Oticon

FDA UDI
Oticon A/S·05707131167248·AGPR, ITC P PB L BE AGIL PRO

Natus

FDA UDI
XLTEK·00382830019170·EMU128 Mini Breakout C (Red)

GUTTA PERCHA POINTS

FDA UDI
DiaDent Group International·08806383502450·Gutta Percha Points is used to root canal filin...

NIAGARA® Lateral Access System

FDA UDI
VB Spine LLC·10888857518018·Anterior Blade (Narrow Long)

ZAVATION

FDA UDI
Zavation LLC·00842166179240·Sizer, 10 deg, 7&8mm

BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT

FDA 510(k)
FDA Class 2 ·Anesthesiology

MASTERGRAFT RESORBABLE CERAMIC GRANULES

FDA 510(k)
FDA Class 2 ·Orthopedic

LUX 1440

FDA Adverse Event
Malfunction ·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012

PORTEX GENERAL ANESTHESIA CIRCUITS

FDA Adverse Event
Malfunction ·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022

TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

FDA Adverse Event
Injury ·EV3 INC.·Product code MCW·May 9, 2013

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC·Product code CBK·August 27, 2014

CORE IMPACTION DRILL

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·May 19, 2011

GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 22, 2023

CONNECTOR C35-O

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code ONB·September 3, 2021

6F Z2 GUIDING CATH SR3.5 SH CATHETER Z26SR35SH Z2 6F 100CM SR35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z26SR35SH

FDA Recall
Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation of tissue in open, laparoscopic , and endoscopic surgeries Model/Catalog Number: WA91307C

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·July 31, 2024

(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE

FDA Recall
Terminated ·Hill-Rom, Inc.·Product code FSA·January 14, 2022