23 results · 33ms · Sources: EU EUDAMED, US FDA

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NEUTROPHASE

FDA 510(k)
FDA Class 1 ·General Hospital

CARDINAL HEALTH

FDA UDI
Cardinal Health 200, LLC·10885380076275·0.8mm Guide Wire 100mm

SchureMed

FDA UDI
SCHUERCH CORPORATION·00810014608891·MIDMARK 2.25" DELUXE GEL

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0310090·Probe, 1.5 inch Ball, Lenke, Thoracic, Curved, ...

Baby Gorilla/Gorilla Plating System

FDA UDI
Paragon 28, Inc.·00889795034526·Gorilla, Posterolateral, Fibular, 09-Hole, w/Co...

RANDOX C-REACTIVE PROTEIN

FDA 510(k)
FDA Class 2 ·Immunology

WHITE MTA MATERIAL

FDA 510(k)
FDA Class 2 ·Dental

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 29, 2024

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·April 16, 2025

WAVEWRITER ALPHA PRIME

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 5, 2023

AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·May 30, 2023

840 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·April 24, 2013

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 14, 2011

AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 25, 2022

HOSP SS FLEXX METER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·February 22, 2011

AEQUALIS REVERSED CEMENTLESS METAPHYSIS HA D.36MM

FDA Adverse Event
Injury ·TORNIER S.A.S.·Product code KWS·April 20, 2023

HOSP SS FLEXX METER W/O LASER

FDA Adverse Event
Injury ·LIFESCAN INC.·Product code NBW·May 17, 2011

HOSP SS FLEXX METER

FDA Adverse Event
Death ·LIFESCAN INC.·Product code NBW·April 1, 2011

AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.

FDA Enforcement
Class II ·Terminated·Cayenne Medical Inc.·August 1, 2018