15 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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STARBRIGHT 5% SODIUM FLUORIDE VARNISH
FDA 510(k)
FDA Class 2
·Dental
QCT Pro Asynchronous Calibration Module, CliniQCT
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DIASYNC0·The QCT Pro Asynchronous Calibration Module is ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197053891·SAROT Hemostatic Forceps
240mm,...
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
K140347
FDA Adverse Event
Injury
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code DZE·May 6, 2021
VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER
FDA 510(k)
FDA Class 2
·Ophthalmic
MODIFICATION TO HRW-127 WRIST ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
CONFIRM
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code MXC·January 13, 2014
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·May 31, 2013
CENTRA BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·June 16, 2011
HISTOACRYL FLEXIBLE PACK 5
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL SA·Product code MPN·February 11, 2020
HISTOACRYL TRANSLUCENT 10 AMP OF 0.5 ML
FDA Adverse Event
Injury
·B. BRAUN SURGICAL SA·Product code MPN·February 26, 2020
Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH2 ; 2 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH3 ; 3 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH4 ; 4 ) LARYNGOSCOPY PACK, Catalog Number: SEN11LGUH5 ; 5 ) STERILE LARYNGOSCOPY PACK, Catalog Number: SEN11LGUHB
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·January 22, 2025
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022