77 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INFRARED EAR THERMOMETER, MODEL ET-101A
FDA 510(k)
FDA Class 2
·General Hospital
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975743·Trumpf Medical/Medizin PST 300L+
PST300
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761967960·PST 300L+
PEGASUS NASAL CPAP SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
QUADRA BROACH SIZE 0
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012
REAMING ROD MEASURING DEVICE
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code LXH·April 29, 2013
GENESIS II
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·May 9, 2011
ONE TOUCH ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·July 24, 2008
VERSAFITCUP CC TRIO 01.26.45.1150 ACETABULAR SHELL CC TRIO NO-HOLE Ø 50
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 7, 2021
VERSAFITCUP CC TRIO ACETABULAR SHELL 58
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code LZO·April 8, 2013
COCR BALL HEADS 32 SIZE M.
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 29, 2011
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 4
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 19, 2017
QUADRA H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·May 15, 2026
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
QUADRA R FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 3, 2026
VERSAFITCUP ACETABULAR SHELL CC TRIO DIAM 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·February 10, 2022
LINER: MPACT HOODED PE HC LINER Ø32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 23, 2019
QUADRA H FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·December 2, 2025
VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 27, 2016