1,693 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mick Valencia Applicator Set
FDA 510(k)
FDA Class 2
·Radiology
PQ Autoclave Pouches (4-1/4" x 12") Blue Film
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724P2301551·Pk. of 200
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123207619·Tissue Fcps 5-1/8 1x2 Matte
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361036166·SCREW, SOLID WALL, CANNULATED, Ø10MM X 55MM, SA...
MUSE CARDIOLOGY INFORMATION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Bright High Flow
FDA 510(k)
FDA Class 2
·Dental
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 6, 2014
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·September 1, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
CONSMA·Product code ITJ·July 16, 2013
CERTAIN¿ BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 4MM(H) Reference Number: IEHA344
FDA Enforcement
Class II
·Terminated·Biomet 3i, LLC·March 4, 2020
Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number: K23055 Software Version: N/A Product Description: An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls. Component: No
FDA Enforcement
Class II
·Ongoing·CooperSurgical, Inc.·December 25, 2024
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 8, 2026
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 8, 2026
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 30, 2025
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code JKA·October 15, 2025
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·February 19, 2026
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026
BD VACUTAINER® SST¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 20, 2026
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 27, 2026
BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·May 26, 2026