19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning
FDA 510(k)
FDA Class 2
·Neurology
Epimed
FDA UDI
EPIMED INTERNATIONAL, INC·00818788020703·22g RW x 4.5" Bella-D® Coudé® Needle
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103551·Modular 3 St Dissector, Insert only, 5mmx45cm
Mediflex Modular III Basic Laparoscopic Instruments
FDA UDI
FLEXBAR MACHINE CORPORATION·00842102103544·Modular 3 St Dissector, Complete Instrument, 5m...
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970478·
XTRA
FDA 510(k)
FDA Class 2
·Anesthesiology
SoftSpot
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
N/A
FDA UDI
Exactech, Inc.·10885862659965·Trial, Monobloc Revision Stem
NA
FDA UDI
Exactech, Inc.·10885862282866·TRIAL, MONOBLOC REVISION STEM, 21x245mm
IOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
BIOGX SARS-COV-2 OPEN SYSTEM REAGENTS FOR BD MAX SYSTEM
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code QJR·May 5, 2021
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·November 11, 2016
CONCERTO II CRT-D
FDA Adverse Event
Death
·MEDTRONIC MED REL, INC.·Product code NIK·August 15, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013
QUATERA 700 BIMANUAL I/A HANDPIECE SET
FDA Adverse Event
Injury
·CARL ZEISS MEDITEC AG (OBERKOCHEN)·Product code FSO·September 8, 2023
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017