39 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PROXEO Twist Cordless Polishing System PL-40 H
FDA 510(k)
FDA Class 1
·Dental
Phantom Tibial Preparation
FDA UDI
ADLER ORTHO SPA·08052693623525·GENUS PANTHEON PHANTOM TIBIAL PREPARATION SZ.3
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772344116·PROTECT.PRO ACTION BACK SUPPORT BLACK M
CODMAN
FDA UDI
Cerenovus, Inc.·10886704066873·CODMAN SLIM-LINE Aneurysm Clip Straight Tandem ...
DJO SURGICAL
FDA UDI
Encore Medical, L.P.·00190446838104·SPECIAL,EMPOWR REV KNEE MONOBLOCK TIBIAL TRAY ...
Symmetry Love
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482043516·Symmetry® Retractor, Love Nerve Root, 90° Angle...
PASS LP
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL·Product code MNI·October 1, 2018
MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
FDA 510(k)
FDA Class 2
·Cardiovascular
PERCLOSE VASCULAR SUTURE DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 11, 2011
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962112823·LOVE NERVE ROOT RETRACTOR, 7 1/2", ANG 90°
TERRA NOVA® MI Access System
FDA UDI
VB Spine LLC·10888857185692·Retractor/Distractor (Long), Size 70 mm Long
GE OEC 9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 21, 2008
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011
LYONS DISSECTING FORCEPS
FDA Adverse Event
Injury
·GYRUS MEDICAL INC.·Product code GEI·June 28, 2013
SMR CONNECTOR SMALL R
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWS·March 7, 2019
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
FDA Enforcement
Class II
·Terminated·Catheter Research, Inc·April 29, 2015
Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Center Santa Rosa
FDA Enforcement
Class II
·Terminated·Resource Optimization & Innovation Llc·April 5, 2017