15 results
·
25ms
·
Sources: EU EUDAMED, US FDA
MICROMEDIC PUNCH & ELUTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Leica Biosystems
FDA UDI
Leica Biosystems Richmond, Inc.·20849832016315·Apex PT Control Box Slides, White
BaseVac
FDA UDI
R. E. Morrison Equipment Inc·D13028000750·2SUR4.40-1-3P | 3P 14 User Dual Surgical Vacuum...
Geniant Cranial
FDA UDI
KOH YOUNG TECHNOLOGY INC.·08800050902055·75 mm Fixation Pin
ACUMED
FDA UDI
Acumed LLC·10806378039683·Lower Extremity Trial Tray Assembly
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D9098000751·CINCH BACK/ DISTAL BENDER - BLUE HANDLE
Portex
FDA UDI
ICU MEDICAL, INC.·15019517076929·
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE)
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
dose-map™
FDA UDI
ASHLAND SPECIALTY INGREDIENTS G.P.·00810106410555·blood irradiator dosimetry system
DAILY ACTIVITY ASSIST DEVICES
FDA Adverse Event
LERADO GLOBAL·Product code ILS·May 8, 2014
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·October 17, 2012
INFUSOR SINGLEDAY 2ML/HR 12PK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2010
2.7MM/3.5MM TI VA-LCP POSTLAT DHP 3H/LT/75MM-SHORT-STER
FDA Adverse Event
Malfunction
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·August 28, 2018
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