21 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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ES-160
FDA 510(k)
FDA Class 2
·Neurology
ADVANCE®
FDA UDI
Microport Orthopedics Inc.·M684K00510201·
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821051020·HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
MBA™ Titanium Subtalar Implant System
FDA UDI
Ascension Orthopedics, Inc.·10381780280484·MBA™ Titanium Subtalar Implant System CANNULATE...
Subtalar MBA Implant System
FDA UDI
Smith & Nephew, Inc.·00885556866030·DRIVER FOR TITANIUM MBA ONLY 3.5MM HRX
MicroAire®
FDA UDI
Microaire Surgical Instruments LLC·00847399004987·SST TWIST DRILL, DENTAL, 2mm Dia. x 65mm
N/A
FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138102989·STANDARD LATEX FREE WOVEN ELASTIC BANDAGE 2INX4...
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00840180500507·Curved Thoracic Gear Shift, Radel Handle
General Instruments
FDA UDI
ALPHATEC SPINE, INC.·00811801030383·Curved Thoracic Gear Shift, Radel Handle
ENDO LINEAR CUTTERS-ECHELON 60MM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
8100 VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
ADVIA CENTAUR CKMB AND TROPONIN ULTRA ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JHX·July 29, 2010
PROTECTA XT DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·April 10, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·April 12, 2011
TENDRIL DX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·May 27, 2008
REF H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·August 9, 2016
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BLK- Absorbable Suture anchor Product Number: 72203708
FDA Enforcement
Class II
·Ongoing·Smith & Nephew, Inc.·October 28, 2020
ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020