29 results · 21ms · Sources: EU EUDAMED, 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