33 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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OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bur PM2-70 80K FC Ø6.0 St
FDA UDI
Bien-Air Surgery SA·17630055517064·
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814541·GENUMEDI SAND SIZE III
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964053597·Endo Carry-on Procedure Kit includes Transport ...
Biliary Drainage Tube
FDA UDI
OLYMPUS MEDICAL SYSTEMS CORP.·04953170046353·
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494463761·Blakesley Biopsy Grasping Forceps
D 4.0mm, WL 1...
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
FDA 510(k)
FDA Class 1
·General Hospital
ESTHETICA
FDA 510(k)
FDA Class 2
·Dental
Widex
FDA UDI
Widex A/S·05706069720341·Widex D-FA P (Warm beige S-330 ) Telecoil, Volu...
Navigation Instruments
FDA UDI
VB Spine LLC·10888857379343·Awl Tap Size Ø7.5 mm SERENGETI
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
JUMAO MEDICAL EQUIPMENT·Product code IOR·May 8, 2013
SHILEY LOW PRESSURE CUFFED
FDA Adverse Event
Injury
·COVIDIEN/FORMERLY TYCO HEALTHCARE·Product code JOH·May 19, 2011
EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 6, 2008
ITREL II
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·May 19, 2014
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Recall
Open, Classified
·New Standard Device Inc·Product code KTT·July 23, 2019
'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
FDA Enforcement
Class II
·Ongoing·New Standard Device Inc·June 21, 2023
Sanarus Visica Treatment System (disposable), Model/Product Code: VP-0500 (single)
FDA Recall
Terminated
·Sanarus Medical Inc·June 16, 2003
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019