12 results · 45ms · Sources: EU EUDAMED, US FDA

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Constellation (CON-001)

FDA 510(k)
FDA Class 2 ·Radiology

CoRoent

FDA UDI
Nuvasive, Inc.·00887517570864·CoRoent Ant TLIF Ti, 14x11x28mm 0°

Pomee

FDA UDI
POMEE CORPORATION·G15772412800·Rankin-crile forceps 6 1/4" straight

OsteoMed

FDA UDI
OSTEOMED LLC·00845694022934·FPS 2.7mm 1st MTP/MPJ Plate Small Right

OsteoMed

FDA UDI
OSTEOMED LLC·00845694077446·FPS 2.7 1st MTP Small Right Plate Sterile Qty 5

HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500

FDA 510(k)
FDA Class 2 ·General Hospital

ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 29, 2025

ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE SYSTEM

FDA Adverse Event
Injury ·CORDIS CORPORATION·Product code NTE·November 21, 2008

APIX TABLE

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011

ACCU-CHEK ® MOBILE TEST STRIPS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 22, 2013

HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019