19 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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KARMAN WHEELCHAIR
FDA 510(k)
FDA Class 1
·Physical Medicine
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040044568·Elevator Cryer #30
Preat
FDA UDI
Preat Corporation·00842092166178·Astra®-compatible Aqua 3.5/4.0 mm Titanium Blan...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092002167·artVeneer life lower posteriors, S, BL1
Preat Implant Prosthetics
FDA UDI
Preat Corporation·00842092166185·Astra®-compatible Aqua 3.5/4.0mm – Milled Ti A...
OPI BAND
FDA 510(k)
FDA Class 2
·Neurology
GE SYSTEM FIVE
FDA 510(k)
FDA Class 2
·Radiology
KIT IMPLANTABLE SLIM TIP LEAD, 50CM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code PMP·January 11, 2021
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011
ENTRIFLEX FEEDING TUBES
FDA Adverse Event
TYCO HEALTHCARE/KENDALL·Product code FPD·February 21, 2008
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·January 7, 2016
Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·October 8, 2014
Lithotomy Pack, catalog #900-2167 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·August 8, 2012
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024
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