19 results
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28ms
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Sources: EU EUDAMED, US FDA
SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E
FDA 510(k)
FDA Class 2
·Anesthesiology
Zirlux
FDA UDI
HENRY SCHEIN, INC.·H65890109250·Zirlux Bite Ver Cyl Eng
Alteon
FDA UDI
Exactech, Inc.·10885862653109·Special Anterior Approach Cip Impactor Alignmen...
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033344170·
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0100250·Caddie Lid, Fixed Cross Links 5.5mm
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248836·
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0100250·Caddie Lid, Fixed Cross Links, 5.5mm
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248812·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00193033248829·
A NEW DAY
FDA UDI
FGX INTERNATIONAL INC.·00191905788770·
ELECTRICATOR MODEL 26000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INSTANT-VIEW BARBITUATE URINE DIP STRIP TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Optetrak Logic
FDA UDI
Exactech, Inc.·10885862233080·INSTRUMENT TRAY, LOGIC CRC, SIZE 2.5
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 14, 2013
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM VG
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·March 4, 2011
VICTORY XL DR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·March 10, 2008
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·October 2, 2019
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020