16 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MFI-Cardiac
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100851·MCNEILL GLOBAL FIXATION RING MEDIUM
Ø3.5mm x 12mm Lateral Mass Screw with Set Screw
FDA UDI
XENCO MEDICAL LLC·B064XM21735121·Ø3.5mm x 12mm Lateral Mass Screw with Set Screw...
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
START JUNIOR
FDA 510(k)
FDA Class 1
·Physical Medicine
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·September 7, 2018
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·September 7, 2018
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 23, 2011
COBAS 311
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 17, 2013
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HWC·June 3, 2016
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoor Rx, Cx.PC.IN.SUM.BK.Rx; Martinez Black Cx Rx, Cx-3.PC.PT.MTZ.BK.Rx
FDA Enforcement
Class II
·Ongoing·Enchroma Inc·November 27, 2024
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025