45 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
XLIF
FDA UDI
Nuvasive, Inc.·00887517053947·XLIF AMS Trial, 10x22mm 10° Modular
GoLIF! Lumbar Interbody Fusion System
FDA UDI
GetSet Surgical SA·07640387660294·GoLIF! Lumbar Interbody Fusion Device, 1 PEEK p...
XLIF
FDA UDI
Nuvasive, Inc.·00887517054067·XLIF AMS Trial, 10x22mm 10° Lollipop
DURAVENT
FDA UDI
Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948005486·DURAVENT UNI 1 IC + 1 ICU, SIZE 10
REPICCI II RESURFACING KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304447639·
CRYOPEN CRYOSURGICAL SYSTEM, K102214
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780375272·Integra® Jarit® Gorney Plastic Surgery Scissors...
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO ACCU-CHEK INFORM METER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Viceroy
FDA UDI
DIOMEDICAL CO.,LTD.·08800113904750·VICEROY Rod - 5.5 (D)5.5x(L)210mm
NIDO Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07315K0122100·T-Handle, Head Persuader
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837026073·PLATEAU Interbody, Straight, Bulleted, 10mm 22m...
LUX Expandable Interbody System
FDA UDI
XENIX MEDICAL LLC·00840493415987·Lumbar Expandable, 10x22x10-14mm, 8 Deg
Trinity
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00853460007337·TRINITY HD Camera Control Unit
LUX Expandable Interbody System
FDA UDI
XENIX MEDICAL LLC·00840493415994·Lumbar Expandable, 10x22x10-14mm, 15 Deg
ZEOS
FDA UDI
SANTA BARBARA IMAGING SYSTEMS, INC.·00812231030011·ZEOS HD CAMERA CONTROL UNIT
AZURE XT DR MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NVZ·April 15, 2025
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 11, 2024
CAPSURE SP
FDA Adverse Event
Injury
·MPRI·Product code DTB·April 11, 2024