18 results · 22ms · Sources: EU EUDAMED, US FDA

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SYNCHRON CONTROL

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

GEN4 DIGITAL

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828109215·GEN4 DIGITAL

LIFEPAK® 12 defibrillator/monitor

FDA UDI
PHYSIO-CONTROL, INC.·00885074855677·LP12AABCAAAACAABAAAAAAAALP12 MONITOR-DEFIB

VITAL SHIELD GOLD NON-STERILE POWDERED LATEX EXAM GLOVES BLUE, WITH AND/OR WITHOUT BUBBLEGUM SCENT, AND WITH PROTEIN LAB

FDA 510(k)
FDA Class 1 ·General Hospital

NARKOMED MRI , NM-MRI

FDA 510(k)
FDA Class 2 ·Anesthesiology

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 11, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·October 8, 2020

HOLDING SLEEVE-LONG

FDA Adverse Event
Malfunction ·SYNTHES (USA)·Product code LXH·February 28, 2013

OMNILINK .035 STENT DELIVERY SYSTEM

FDA Adverse Event
Injury ·AV-TEMECULA-CT·Product code FGE·March 1, 2011

ANALYTICAL E MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 21, 2008

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 12, 2020

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code NKB·November 25, 2020

UNFOLDER EMERALD

FDA Adverse Event
Malfunction ·AMO PUERTO RICO MFG. INC.·Product code KYB·December 31, 2024

ACUVUE OASYS

FDA Adverse Event
Injury ·JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND·Product code LPM·May 3, 2018

smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024

1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024