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

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ESTEMP NE

FDA 510(k)
FDA Class 2 ·Dental

ONETRAC LX

FDA UDI
OBP CORPORATION·M648C1002900·Retractor 135X20mm with Built-In Single-Use Mul...

Bur PM2-70 50K Steel Ø0.6

FDA UDI
Bien-Air Surgery SA·07630055502636·

ADVIA® Autoslide Modified Wright's Buffer

FDA UDI
Siemens Healthcare Diagnostics Inc.·00630414503967·ADVIA® Autoslide Modified Wright's Buffer

METZENBAUM SCISSORS

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896047051·METZENBAUM SCISSORS CURVED TUNGSTEN CARBIDE BLADE

Merit Medical®

FDA UDI
Merit Medical Systems, Inc.·00884450320808·

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTL.·Product code MNI·October 14, 2011

STar™ Drive Electrode Carrier

FDA UDI
FHC, INC.·10873263002909·Single Electrode Carriers, 2x, non-sterile

LAZERSMILE, LAZERWHITE

FDA 510(k)
FDA Class 1 ·Dental

IMPLANTABLE CLIP

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

SURGICAL UNKNOWN

FDA Adverse Event
Malfunction ·TELEFLEX MEDICAL·Product code GDT·August 3, 2012

PASS LP

FDA Adverse Event
Injury ·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011

ACCU-CHEK ® MULTICLIX

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 8, 2013

ASR UNI FEMORAL IMPL SIZE 46

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL LTD.-8010379·Product code KWA·September 18, 2014

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 24, 2011

SMR CEMENTLESS FINNED STEM

FDA Adverse Event
Injury ·LIMACORPORATE S.P.A.·Product code HSD·April 8, 2022

MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

FDA Enforcement
Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015

TherMax Blood Warmer Unit

FDA Enforcement
Class II ·Terminated·Baxter Healthcare Corporation·November 6, 2019

Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

FDA Enforcement
Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014