16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
FDA 510(k)
FDA Class 2
·Ophthalmic
Sphero Attachments
FDA UDI
Preat Corporation·00842092110782·Sphero Retrofit Kit
THD Anopress
FDA UDI
THD SPA·18033737711245·THD Anopress is a portable system that allows t...
ACUMED
FDA UDI
Acumed LLC·10806378040238·Uni. Tray Calcaneal Plate Insert Lid
ORTHO ARCH
FDA UDI
Ortho Arch Company Inc·D90980014010·ANDERSON GAUGE
Cranial Blade Disposable low speed
FDA UDI
ACRA-CUT INC·00810607000415·Cranial Blade Disposable Low Speed 800-140 Pack...
Electrode
FDA UDI
SOPRO-COMEG GmbH·04059082009742·
Cranial Blade Disposable low speed
FDA UDI
ACRA-CUT INC·00810607000408·Cranial Blade Disposable Low Speed 800-140 Sing...
LAURIMED SPINAL INJECTION SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
CLINI-DENT
FDA 510(k)
FDA Class 1
·Dental
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·May 8, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 12, 2012
33CM PKS OMNI INSTRUMENT
FDA Adverse Event
Malfunction
·GYRUS MEDICAL, INC.·Product code GEI·August 10, 2010
ACTIS COLLARED HIGH SIZE 8
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code MEH·July 8, 2025
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022