29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
FDA 510(k)
FDA Class 2
·Microbiology
MLX
FDA UDI
Nuvasive, Inc.·00887517729293·MLX Graft Containment Plate, 8mm
Batrik Brush/Blue/BD 8mm/BL 50mm
FDA UDI
Batrik Medical Manufacturing Inc·00690521007925·Brush/Blue/BD 8mm/BL 50mm/OL 80cm - Symetric Do...
SchureMed
FDA UDI
SCHUERCH CORPORATION·00810014603957·AMSCO DELUXE-1080/2080 2"POLYFOAM W/ SOFTCARE CVR
Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613215050·STRYKER® OSCILLATING BLADE REPLACEMENT
VADER Pedicle System, Rod, Ti, Straight, Ø 6.0 r000 x 80 mm
FDA UDI
icotec AG·07640164847146·VADER Pedicle System, Rod, Ti, Straight, Ø 6.0 ...
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·VIDAS FREE PSA RT ASSAY
QUICKVUE ADVANCE PH AND AMINES GLL TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX
FDA 510(k)
FDA Class 2
·Neurology
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·VIDAS FREE PSA RT
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·VIDAS FREE PSA (FPSA) ASSAY
PATIENT INFORMATION CENTER IX
FDA Adverse Event
Death
·PHILIPS NORTH AMERICA LLC·Product code MHX·December 28, 2021
PORTEX UNIPERC REPLACEMENT INNER CANNULA
FDA Adverse Event
Injury
·SMITHS MEDICAL ASD, INC.·Product code BTO·April 30, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 4, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 29, 2026
VISION HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·GISH BIOMEDICAL, INC.·Product code DTZ·February 18, 2011
ADVIA 1800
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code CEM·April 26, 2013
VITALITY 2
FDA Adverse Event
Death
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·May 6, 2011
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 17, 2008
JAWS STAPLE SYSTEM
FDA Adverse Event
Injury
·PARAGON 28, INC.·Product code JDR·October 20, 2017