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