15 results · 21ms · Sources: EU EUDAMED, 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