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