21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LMNT O2
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187585·Integra® Jarit® Hibbs Chisel, 9-3/4", Curved, 7/8"
DD base P HI
FDA UDI
Dental Direkt GmbH·EDDIK501251·DD medical polymers (PMMA), made from PMMA, are...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117490·Distal Reamer (Hudson)
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036037499·
Stainless Steel Goldtone Archwire
FDA UDI
Ortho Arch Company Inc·D90925012512·.018 X .022 UPPER GOLDTONE SS
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192664·Distal Reamer (Hudson)
Stem Impactor B
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215058067·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250125200·ceraMotion® Zr Incisal Modifier opal grey, 20g ...
STILLE Retractors
FDA UDI
Stille AB·07332339212018·SKIN HOOK JOSEPH STILLE double hook 5 mm 16 cm ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197162708·Micro Micro Curette
angled...
RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Elite Nitinol Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANTABLE COLLAMER LENS (ICL)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·May 4, 2017
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·August 22, 2013
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·December 15, 2016
HIP INSTRUMENTS
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LXH·March 28, 2025
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013