17 results
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34ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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VITEK 2 STRPTOCOCCUS AMPICILLIN
FDA 510(k)
FDA Class 2
·Microbiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017699·K-Wire, Double Ended, Trocar Point, Diameter Si...
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000034689·PROSTHESIS 1112075 H/A INCUS 3.75MM
NA
FDA UDI
MEDTRONIC XOMED, INC.·00681490033336·PROSTHESIS 1112075 H/A INCUS 3.75MM
N/A
FDA UDI
MEDTRONIC XOMED, INC.·00763000913625·PROSTHESIS 1112075 H/A INCUS 3.75MM
DENALI
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042120266·Reverse Action Keat Buccal Tube Tweezer
UCR
FDA UDI
Seaspine Orthopedics Corporation·10889981063269·CROSSBAR, LARGE, 5.5 ROD
Integrity-SI Fusion System
FDA UDI
Lincotek Medical LLC·B57112521112075D0·12 x 75 mm Anodized SI Implant Fully Threaded
ORTHO EASY PIN
FDA 510(k)
FDA Class 2
·Dental
IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6
FDA 510(k)
FDA Class 2
·Microbiology
MARKED SPRINGTIP GW
FDA Adverse Event
Malfunction
·CONMED ENDOSCOPIC TECHNOLOGIES·Product code KOG·February 17, 2006
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Death
·AV-TEMECULA-CT·Product code NIM·June 2, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·August 15, 2008
STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.
FDA Enforcement
Class II
·Terminated·Advanced Sterilization Products·April 10, 2013
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021