29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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