15 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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S45 Digital Color Doppler Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
NA
FDA UDI
MAKO SURGICAL CORP.·00848486020620·ACETABULAR REAMER ¿ 64mm
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017804·K-Wire, Double Ended, Trocar Point, Diameter Si...
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221045041·Unitek(TM) Molar Band General Purpose Narrow Re...
Denovo general purpose dental molar band
FDA UDI
Denovo Dental, Inc.·00810059290761·Denovo general purpose dental molar band - Mand...
TRANSET SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION SPECTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·February 13, 2025
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
BALL HEADS: MECTACER HEAD BIOLOX OPTION Ø 28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 20, 2024
CAPSUREFIX MRI
FDA Adverse Event
Injury
·MPRI·Product code NVN·June 10, 2013
NDHP 0.2 MICRN HP CL
FDA Adverse Event
Malfunction
·HOSPIRA LTD.·Product code FPA·April 28, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 16, 2008
CUP: MPACT ACETABULAR SHELL Ø50 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 26, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024