19 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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BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
BD PHASEAL¿ INJECTOR LUER LOCK N35C
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONG·December 1, 2017
BD PHASEAL¿ CONNECTOR LUER LOCK (C35)
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code ONB·November 13, 2019
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550179·GENUMEDI PT KNEE SUP SILVER R EW III
Zavation
FDA UDI
Zavation LLC·00842166188846·Custom ALIF Sizer
RDH-2000
FDA 510(k)
FDA Class 1
·Dental
FINESS ENDOSCOPE STERILIZATION TRAY
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
GENDRON, INC.·00842307101154·STRETCHER,CHR FRM,ENAM LTR
NA
FDA UDI
GENDRON, INC.·00842307100034·STRETCHER,CHR FRM,ENAM LTR, UTILITY SHELF
NA
FDA UDI
GENDRON, INC.·00842307102571·STRETCHER,CHR FRM,ENAM LTR
NA
FDA UDI
GENDRON, INC.·00842307100010·STRETCHER,CHR FRM,ENAM LTR
NA
FDA UDI
GENDRON, INC.·00842307102281·STRETCHER,CHR FRM,ENAM LTR INCLUDES: ...
NA
FDA UDI
GENDRON, INC.·00842307103042·STRETCHER,CHR FRM,ENAM LTR
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
PRESICE
FDA Adverse Event
Malfunction
·GALIL MEDICAL·Product code GEH·August 21, 2008
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04 FA-88810-30V06 FA-88810-40V04 FA-88810-40V06 FA-88810-50V04 FA-88810-50V06
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 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