18 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TXCELL SCANNING LASER DELIVERY SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JOBST UltraSheer
FDA UDI
BSN MEDICAL, INC.·00035664214753·ULTRA SHEER 30-40 MM HG KNEE HIGH CLOSED TOE LA...
TRIDENT SPLITTER
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072596·TRIDENT SPLITTER STRAIGHT TIP TITANIUM
VuMesh™
FDA UDI
Seaspine Orthopedics Corporation·10889981036621·14mm Sq 7.5 Deg End Cap
COMPRESS ANTI-ROTATION SPINDLES
FDA 510(k)
FDA Class 3
·Orthopedic
BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 11, 2022
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 2, 2015
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·April 8, 2021
NEEDLE 30X1/2 RB
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·June 29, 2021
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·March 13, 2023
BD PRECISIONGLIDE¿ NEEDLES
FDA Adverse Event
Injury
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·May 31, 2023
NDLE 25GA 7/8IN ECG BLT NO-ANL TRANS ORN
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 18, 2019
BD PRECISIONGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·July 31, 2019
CPS TIB SPINDLE LT 12X37X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019
The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
FDA Enforcement
Class II
·Ongoing·Abbott Medical·January 1, 2025