14 results
·
27ms
·
Sources: EU EUDAMED, US FDA
DAVOL/ABAMSON SILICONE SUMP DRAIN
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Bard® Urethral Catheterization Tray with Plastic Catheter
FDA UDI
C. R. Bard, Inc.·00801741040245·Bard® Urethral Catheterization Tray with Plasti...
TruLock
FDA UDI
Rmo, Inc.·00885797644923·TRULOCK Primer Activated Adhesive Kit (4ea Syri...
THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope
FDA UDI
THD SPA·08033737710401·The THD Light-Scope rectoscope is a disposable ...
0800,APS0,08,N,RA,RDL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828155755·0800,APS0,08,N,RA,RDL
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D90980008114·DELUXE BOLEY GAUGE CURVED
ACUMED
FDA UDI
Acumed LLC·10806378039744·Locking Elbow Screw Caddy Lids
ENTEROSCOPY OVERTUBE, MODEL 00712140
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 8, 2014
PEAK PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 17, 2012
2800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 11, 2010
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS·November 5, 2025