19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEDILOC FRAGMENT SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257141496·20-30 MFW VITALITY CALF CT CHARC I
AGXO
FDA UDI
Oticon A/S·05707131270207·H110, DESIGNRITE 10 WL SIL AGXO
AGILITY
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295035640·AGILITY LP TOTAL ANKLE SYSTEM +1 POLY INSERT SI...
AGILITY
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295035633·AGILITY LP TOTAL ANKLE SYSTEM POLY INSERT SIZE 1
HALO90 ULTRA ABLATION CATHETER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2
FDA 510(k)
FDA Class 2
·Immunology
REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
FDA Adverse Event
Injury
·SHASER INC·Product code ONF·May 21, 2021
MAXZERO
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·March 17, 2026
EASYTRAK 3 IS-1
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code LWP·October 3, 2014
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·May 31, 2013
PIN COLLET
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code GET·June 17, 2011
BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 21, 2023
BD MAXZERO¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·June 10, 2022
MAXZERO NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·CFN MEXICO 215 SA DE CV·Product code FPA·May 12, 2020
CORE, MAESTRO DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HBB·April 24, 2019
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 19, 2023
BD MAXZERO¿ MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·May 18, 2023
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015