29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ASTOFLO
FDA 510(k)
FDA Class 2
·Hematology
Affiniti™ Cortiloc™
FDA UDI
TORNIER, INC.·00846832002122·
Promolux High Impact
FDA UDI
Merz Dental GmbH·D7091020060·Promolux High Impact Monomer, 1000ml
Santis Straight Rod 5.5mmx60mm
FDA UDI
Lanterna Medical Technologies GmbH·07640159550723·Santis Straight Rod 5.5mmx60mm
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717100581·Gloves Nitrile Thin Powder-Free Small 3.0G, Pkg...
SANTIS™ STRAIGHT ROD 5.5mm X 60mm -STERILE
FDA UDI
Lanterna Medical Technologies GmbH·07640159551843·SANTIS™ STRAIGHT ROD 5.5mm X 60mm -STERILE
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710410200600·Anterior Closing Wedge Osteotomy Guide, 20mm x...
Intelliguides
FDA UDI
Mios Marketing, LLC·G2710420200600·Anterior Lateral Closing Wedge Osteotomy Guide,...
ASP MEDICAL
FDA UDI
Asp Global, LLC·00840216123014·GOWN, ISOLATION LEVEL 1, BLUE, UNIVERSAL SIZE, ...
GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NATURAL ORDINARY RIBBED,DOTTED,AND CONTOURED (MALE RUBBER LATEX CONDOM, LUBRICATED W/SILICONE OIL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HALL MICRO CHOICE HIGH SPEED DRILL
FDA Adverse Event
Injury
·LINVATEC·Product code DZI·June 19, 1997
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Tornier, Inc·August 5, 2015
Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
FDA Recall
Terminated
·Tornier, Inc·Product code HSB·June 25, 2015
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
MEDEL S.P.A.·Product code BTI·March 25, 2013
HUMERAL HEAD IMPACTOR
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·March 10, 2011
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RATE 2mL/Hr, Model # CT-0020-060 Item # RFC060020. Manufactured by Medpro International (Thailand) Ltd.
FDA Recall
Terminated
·Wolf Medical Supply Inc.·Product code MEB·October 20, 2011
MOTOR ASSY, J3
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·August 7, 2019
ARCOM XL 44-36 STD +3 HMRL BRG
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·November 13, 2019