21 results · 26ms · Sources: EU EUDAMED, US FDA

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MODIFICATION TO MARSPO2, MODEL 2001

FDA 510(k)
FDA Class 2 ·Cardiovascular

CUSTOM PROCEDURE KIT

FDA UDI
MEDIVATORS INC.·40677964006720·The ENDO CARRY-ON Procedure Kit contains all of...

PowerPICC

FDA UDI
Bard Access Systems, Inc.·00801741144769·Catheter Placement Kit

TruLock

FDA UDI
Rmo, Inc.·00885797658289·TRULOCK Light Activated Adhesive Kit (4ea Syrin...

LIFENET Adapter 32-BIT

FDA UDI
PHYSIO-CONTROL, INC.·00883873903438·LIFENET Adapter 32-BIT RELEASE 5.3.3

DIGITAL INFLECTION RIGIDOMETER (DIR)

FDA 510(k)
FDA Unclassified ·Unknown

MODIFICATION TO CD HORIZON SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 16, 2011

DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code PQF·June 2, 2017

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·March 12, 2013

COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011

ACHALASIA PNEUMATIC HAND PUMP AND MONITOR

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code GBA·February 21, 2008

Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - 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

UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

FDA Adverse Event
Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

FDA Enforcement
Class II ·Ongoing·B-K Medical A/S·November 12, 2025