17 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Dental unit Model: Mare
FDA 510(k)
FDA Class 1
·Dental
MILAGRO
FDA UDI
DEPUY MITEK, LLC·10886705010844·MILAGRO INTERFERENCE SCREW Absorbable - TCP/PLG...
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102244·SLOANE LASEK EPI PEELER
NA
FDA UDI
Zimmer, Inc.·00889024049505·
NA
FDA UDI
Zimmer, Inc.·00889024049512·
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
FDA 510(k)
FDA Class 2
·Orthopedic
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
FDA 510(k)
FDA Class 2
·Physical Medicine
ID NOW COVID-19 2.0 TEST KIT 24T OUS
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 11, 2024
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 15, 2015
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 1, 2011
9710055-2008-00005
FDA Adverse Event
Other
·Product code FSY·August 1, 2008
GYNECARE TVT SECUR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code PAH·July 17, 2013
ID NOW COVID-19 2.0 TEST KIT 24T OUS
FDA Adverse Event
Injury
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 11, 2024
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024