18 results · 31ms · Sources: EU EUDAMED, US FDA

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Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

FDA 510(k)
FDA Class 2 ·General Hospital

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III

CEMEX SYSTEM GUN APPLICATION VERSION

FDA 510(k)
FDA Class 2 ·Orthopedic

STERILE DISPOSABLE VINYL EXAM GLOVES, POWDER FREE

FDA 510(k)
FDA Class 1 ·General Hospital

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 26, 2016

NAIL, FIXATION, BONE

FDA Adverse Event
Injury ·SYNTHES USA·Product code JDS·July 27, 2016

SYMPHONY

FDA Adverse Event
Injury ·SORIN CRM·Product code NVZ·January 28, 2011

SYNCHROMED

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·September 25, 2009

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

TPS UNIVERSAL DRIVER

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code ERL·July 1, 2011

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

IQECG

FDA Adverse Event
Malfunction ·BRENTWOOD MED TECHNOLOGY DBA MIDMARK DIAGNOSTICS GROUP·Product code DSI·May 17, 2010

ORTHOSIS, PEDICLE SPINAL FIXATION

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNI·May 1, 2019

ORTHOSIS, PEDICLE SPINAL FIXATION

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNI·May 1, 2019

ORTHOSIS, PEDICLE SPINAL FIXATION

FDA Adverse Event
Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code MNI·May 1, 2019

Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.

FDA Enforcement
Class II ·Terminated·Toshiba American Medical Systems Inc·April 3, 2013

CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

FDA Enforcement
Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025