23 results
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20ms
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Sources: EU EUDAMED, US FDA
OXYGEN SUPPLY TUBING, MODEL 1115
FDA 510(k)
FDA Class 1
·Anesthesiology
Endo Carry-on Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964153198·Endo Carry-on Procedure Kit contains Intercept ...
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040014059·Zirlux 16+ B3 98.5X20
Mesh
FDA UDI
Nuvasive, Inc.·00887517063908·Mesh, 20x60mm
BLUE MERLIN
FDA UDI
FGX INTERNATIONAL INC.·00193033245590·
BLUE MERLIN
FDA UDI
FGX INTERNATIONAL INC.·00193033245552·
BLUE MERLIN
FDA UDI
FGX INTERNATIONAL INC.·00193033245545·
BLUE MERLIN
FDA UDI
FGX INTERNATIONAL INC.·00193033245569·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112340·Tap, 6.50mm, Fixed Sleeve
GAZELLE BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
IMMULITE 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·May 22, 2018
ENDOTRACHEAL TUBE 8229306 NIM EMG 6MM RE
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code ETN·March 14, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·March 8, 2011
PASSIVE PLUS
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008
NEUROSTIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code MHY·April 26, 2012
U-40 MONOJECT !/2 ML SYRINGE 25G X1/2 "
FDA Adverse Event
Malfunction
·COVIDIEN·Product code FMF·July 16, 2020
Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients who are experiencing degenerative arthritis.
FDA Recall
Terminated
·Product code HRY·April 22, 2011
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014