27 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RDT3 HANDPIECE HEAD MODEL RDT3
FDA 510(k)
FDA Class 1
·Dental
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317300317·
Tasso+ Convenience Kit
FDA UDI
Tasso Inc.·00860006434502·Tasso+ allows self-collection of a capillary bl...
Sklar
FDA UDI
SKLAR CORPORATION·10649111288623·PITCHER/BEAKER 125ML
Clean-Bor Tube 1-3/8" x 72"
FDA UDI
Vacumed·00850644007794·Clean-Bor Tube
Clean-Bor Tube 1-3/8" x 72"
FDA UDI
Vacumed·00850644007800·Clean-Bor Tube
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295000549·PROTRUSIO CAGE CEMENTED ACETABULAR RECONSTRUCTI...
ARTHREX BIO-TRANSFIX
FDA 510(k)
FDA Class 2
·Orthopedic
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD¿ 20 ML SYRINGE WITH NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·December 16, 2021
BD SYRINGE S2 20ML
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·November 8, 2021
IOLMASTER 500
FDA Adverse Event
Malfunction
·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015
ELLIPSE DR, DF4 CONNECTOR
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 9, 2013
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 3, 2014
ULTRAVAC 90 WITH INTEGRATED CABLE
FDA Adverse Event
Other
·ARTHROCARE CORP.·Product code GEI·May 18, 2011
IMMULITE® 2000 3GALLERGY SPECIFIC IGE
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·December 11, 2024
IMMULITE 2000 3GALLERGY SPECIFIC IGE UNIVERSAL KIT (SPE)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED·Product code DHB·October 1, 2022
TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0155/25, Stem size S-6, prox. Stem dia. 25 mm, Length 180 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg
FDA Enforcement
Class II
·Terminated·Waldemar Link GmbH & Co. KG (Corp. Hq.)·September 4, 2013
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·March 4, 2015