23 results
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39ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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InnovaMatrix FS
FDA 510(k)
FDA Unclassified
·Unknown
Zodiac
FDA UDI
ALPHATEC SPINE, INC.·00844856003392·TI 5.5MM TELESCOPING BRIDGE, 80MM
Mariner Deformity
FDA UDI
Seaspine Orthopedics Corporation·10889981247850·Lamina Hook, 10.5H X 8.0W
Inertia® Pedicle Screw and Deformity Correxxion® System
FDA UDI
NEXXT SPINE, LLC·00889929027295·MAC Pedicle Screw, Ø10.5x80 mm
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086901·FEMORAL MEDIAL CURVED REAMER 19.5mm
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086895·FEMORAL MEDIAL CURVED REAMER 18mm
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086871·FEMORAL MEDIAL CURVED REAMER 15mm
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086888·FEMORAL MEDIAL CURVED REAMER 16.5mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197538244·Müller Femoral Retractor Lever
330mm,...
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086864·FEMORAL MEDIAL CURVED REAMER 13.5mm
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086840·FEMORAL MEDIAL CURVED REAMER 10.5mm
EUROPA™ Pedicle Screw
FDA UDI
MIRUS LLC·00810025483081·Ø10.5 X 80mm EUROPA™ Pedicle Screw
NA
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295086857·FEMORAL MEDIAL CURVED REAMER 12mm
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
PALOMAR SLP 1000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
I-STAT 6+ CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code JGS·September 28, 2021
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 29, 2014
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code MIH·August 10, 2011
EPIC II VR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 8, 2013
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a specially designed analyzer, the HemoCue Glucose 201 with Plasma conversion. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels.
FDA Enforcement
Class II
·Terminated·HemoCue AB·September 18, 2013