16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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iLet® Dosing Decision Software
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916123031·Zeus-P Implant 16 x 9 x 22mm
PANDOR™ DeBakey Extra-Fine M-P Clamp 45° 37mm 16cm curved shanks
FDA UDI
Geister Medizintechnik GmbH·04057034058268·PANDOR™ DeBakey Extra-Fine M-P Clamp
45° 37...
ZEUS-P
FDA UDI
SPINAL ELEMENTS·00840916153540·Zeus PLIF, Curved Cage 22mm x 09mm x 16mm
Patient Administration Set
FDA 510(k)
FDA Class 2
·Radiology
QFIX RADIOTHERAPY CHAIR
FDA 510(k)
FDA Class 2
·Radiology
BD SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·August 30, 2019
MINIMED, NOVOLOG INSULIN
FDA Adverse Event
Death
·MEDTRONIC·Product code LZG·November 4, 2008
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 23, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 11, 2013
MEDLINE INDUSTRIES,LP
FDA Adverse Event
Malfunction
·ZHEJIANG KINDLY MEDICAL DEVICES CO.,LTD·Product code JKA·August 28, 2025
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 26, 2023
LIFE SCOPE PT
FDA Adverse Event
Malfunction
·NIHON KOHDEN CORPORATION·Product code MHX·December 8, 2023
BD 1ML SYRINGE LUER-LOK TIP
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·September 11, 2019
SINGLE USE GUIDEWIRE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code OCY·May 16, 2023
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
FDA Enforcement
Class I
·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024