20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ENCORE 26 ADVANTAGE KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Unity Total Knee System
FDA UDI
CORIN LTD·05055343897782·Tibial Augment 5mm RM-LL size 7
SBH
FDA UDI
SBH Surgical·00850068304011·1/1, Sterilization Container Perforated Lid, Bl...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814770·GENUMEDI EXTRA WIDE SILVER SIZE IV
M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
FDA 510(k)
FDA Class 2
·Cardiovascular
TLINK DATA MANAGEMENT SYSTEM (DMS)
FDA 510(k)
FDA Class 2
·Cardiovascular
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
ARCOS 18X150MM SPL TPR DIST
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 23, 2024
ARCOS CON SZ C HI 80MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·January 23, 2024
EDP 30/S
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code LWS·October 28, 2008
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
DUAL MOBILITY VIVACIT-E HIGHLY CROSSLINKED BEARING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·June 19, 2024
ACCESS ACCUTNI REAGENT
FDA Adverse Event
Injury
·BECKMAN COULTER·Product code MMI·September 15, 2016
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
FDA Enforcement
Class I
·Terminated·Brainlab AG·January 27, 2016
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018