390 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CHUMP
FDA 510(k)
FDA Class 1
·Physical Medicine
Tornier Latitude
FDA UDI
TORNIER, INC.·00846832014774·HUMERAL SPOOL TRIAL
Humelock II
FDA UDI
FX SOLUTIONS·03701037320532·HUMELOCK II TRAY
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037308967·HUMELOCK REVERSED STOP DRILL
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100170·SNII Tap, 5.50mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710310300170·Talar Osteotmy Guide, 30mm x 17mm
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710820300170·Zadik Calcaneal Guide, 30mm x 17°
PARSET SECONDARY ADMINISTRATION SET, LUERLOCK, MODEL A14001E, PARSET SECONDARY SECONDARY ADMINISTRATION SET, MODEL A1400
FDA 510(k)
FDA Class 2
·General Hospital
GRAMSORB SYNTHETIC ABSORBABLE SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
7.0MM TI SIDE-OPENING SCREW 45MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MNH·April 2, 2013
GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COI
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code HCG·March 25, 2011
ACCU-CHEK ULTRAFLEX INFUSION SET
FDA Adverse Event
Injury
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·April 14, 2008
BACFIX ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·Precision Spinal Cord Stimulator (SCS) Systems
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA Pre-Market Approval
FDA Class 3
·PRECISION SPINAL CORD STIMULATION (SCS)SYSTEM INTRODUCER