12 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ALIF
FDA UDI
Nuvasive, Inc.·00887517690883·ALIF Paddle Distractor, 10mm Narrow Left
artegral
FDA UDI
Merz Dental GmbH·D7091970100·anteriors; shade A3.5; mould IL
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938825·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939990·Percutaneous Transluminal Angioplasty Balloon C...
JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW
FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937651·Percutaneous Transluminal Angioplasty Balloon C...
HASELMEIER PEN
FDA 510(k)
FDA Class 2
·General Hospital
CreoDent Solidex Customized Abutment and Screw
FDA 510(k)
FDA Class 2
·Dental
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-RIO
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·April 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 20, 2013
GAMBRO CARTRIDGE BLOOD SET
FDA Adverse Event
Death
·GAMBRO RENAL PRODUCTS S.A. DE C.V.·Product code FJK·January 19, 2011
BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020