3,433 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DOCTOR'S KIT DKS RhD-25
FDA UDI
Eldon Biologicals A/S·05713494000351·For 75 RhD blood group determinations. Not for ...
DOCTOR´S KIT DKS RhD-25
FDA UDI
Eldon Biologicals A/S·05713494000085·For 75 RhD blood group determinations. Dry form...
Siemens
FDA UDI
Ws Audiology Usa, Inc.·04046355298897·Siemens HA MOTION 701 S DKS Hearing Aid
Siemens
FDA UDI
Ws Audiology Usa, Inc.·04046355359376·Siemens HA MOTION 301 S DKS Hearing Aid
Siemens
FDA UDI
Ws Audiology Usa, Inc.·04046355298989·Siemens HA MOTION 501 S DKS Hearing Aid
UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS
FDA Adverse Event
Injury
·MEDOS INTERNATIONAL SÃ RL CH·Product code MNH·June 4, 2024
ALTERRA ADAPTIVE PRESTENT
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code NPV·January 6, 2025
MULTI-WAY CONNECTING SET 4 SS
FDA Adverse Event
Malfunction
·DKS LOVERSAN D.O.O.·Product code LHI·April 23, 2020
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024
DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Large Obturator Trocar (Model Number 330.017) 2. DKS Large Lighted Cannula (Model Number 330.011) 3. DKS Large Kerrison (330.015) 4. DKS Small Obturator Trocar (330.013) 5. DKs Small Lighted Cannula (330.014) 6. DKS Small Kerrison (330.016)
FDA Recall
Open, Classified
·Folsom Metal Products, Inc.·Product code HAE·October 30, 2023
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
FDA Enforcement
Class II
·Ongoing·Folsom Metal Products, Inc.·December 18, 2024
Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)
FDA Recall
Open, Classified
·Folsom Metal Products, Inc.·Product code HAE·October 30, 2023
V-GO DISPOSABLE INSULIN DELIVERY DEVICE
FDA Adverse Event
Injury
·VALERITAS, INC.·Product code LZG·October 23, 2014
CARDIOCEL
FDA Adverse Event
Injury
·ADMEDUS REGEN PTY LTD·Product code DXZ·March 13, 2015
INDUO
FDA Adverse Event
Injury
·NOVO NORDISK A/S, MEDICAL SYSTEMS·Product code FMF·July 23, 2002
Plate, Silica Gel, Tlc
FDA classification
FDA Class 1
·Plate, Silica Gel, Tlc
DBS SYSTEM S.A
FDA registration
DBS SYSTEM S.A·1 product·🇨🇭 Switzerland
DAS MEDICAL INTERNATIONAL, SRL
FDA registration
DAS MEDICAL INTERNATIONAL, SRL·14 products·🇩🇴 Dominican Republic
BKS FABRICS PRIVATE LIMITED
FDA registration
BKS FABRICS PRIVATE LIMITED·1 product·🇮🇳 India
BKS Revision System
FDA 510(k)
FDA Class 2
·Orthopedic