30 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
FDA 510(k)
FDA Class 1
·Dental
JET AUTOMATIC WIRE TWISTER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896051829·JET AUTOMATIC WIRE TWISTER WITH CUTTER
NexxZr™ / W-98-16-UT-D300-ML
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271139764·
GEN4 DIGITAL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828110549·GEN4 DIGITAL
ROCHE DIAGNOSTICS CK-MB
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LIC INSTRUMENT PROCESSING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CLEARLINK PACLITAXEL SETS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026
SEE H10
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
ASKU
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026
DUO-VENT CLEARLINK LUER ACTIVATED VALVE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
TALENT THORACIC
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
OT ULTRALINK METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·May 25, 2011
NI
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017
150 MICRON TFL SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC·Product code GEX·September 1, 2021
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
FDA Enforcement
Class II
·Terminated·Cardio Medical Products·July 17, 2013