14 results · 21ms · Sources: EU EUDAMED, US FDA

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ORGENTEC ABTI-SS-BB(LA) ELISA

FDA 510(k)
FDA Class 2 ·Immunology

Hemoglobin Capillary Collection System (HCCS)

FDA UDI
BIO-RAD LABORATORIES, INC.·00847817002762·For the collection of human whole blood for the...

P.F.C. SIGMA

FDA UDI
DEPUY (IRELAND)·10603295240938·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING CURVED...

MILLENNIUM

FDA UDI
Avalign Technologies, Inc.·00190776335168·Cooley Cardio Scissor

LMT NOMAG IC 3.0

FDA 510(k)
FDA Class 2 ·General Hospital

Sentinella 102, Sentinella 102 Horus

FDA 510(k)
FDA Class 1 ·Radiology

THERMAL SENSORY ANALYZER (TSA-II)

FDA Adverse Event
Injury ·MEDOC LTD., ADVANCED MEDICAL SURGERY MEDISCENSE USA·Product code LQW·December 26, 2019

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·February 14, 2013

COLLEAGUE CXE VOLUMETRICINFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 17, 2011

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE·Product code KDJ·July 28, 2014

CANNULATED 4.0MM HEXAGONAL SCREWDRIVER

FDA Adverse Event
Malfunction ·SYNTHES GMBH·Product code HXX·November 24, 2020

MBT CEM KEEL TIB TRAY SZ5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·May 16, 2019

QSENSE CPM THERMAL SENSORY ANALYZER 2001

FDA Adverse Event
Malfunction ·MEDOC LTD, ADVANCED MEDICAL SYSTEM·Product code LQW·April 19, 2022

HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026