17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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THD DISPOSABLE ANOSCOPE/PROCTOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Control Units
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968011·Remote Control PST 300+ W
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761976351·Trumpf Medical/Medizin Remote Control PST 300+ W
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014604640·TABLE WIDTH EXTENDER PAD 11" X 8" X 1"
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179536·
ADARA
FDA UDI
HNM TOTAL RECON LLC·00841742102764·ADARA ø4.5mm Cortical Screw, Full Thread, SS - ...
NA
FDA UDI
STRYKER CORPORATION·07613327052213·Knot Pusher
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
FDA 510(k)
FDA Class 2
·Dental
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
FDA 510(k)
FDA Class 2
·Immunology
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMF·August 20, 2024
S5 CONSOLE FOR 4 PUMP
FDA Adverse Event
Malfunction
·SORIN GROUP DEUTSCHLAND·Product code DTQ·July 1, 2010
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 6, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MKJ·July 17, 2008
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024