19 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526743557·LEVAMED ANKLE SUPPORT SILVER IV
CM-hex screw system
FDA UDI
Cendres+Métaux SA·07640166514558·CM-hex screw system
Screw tap holder
(for paral...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108698176·Final Drill Stop for L8mm Implant, Extra Wide
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108697711·Titanium Base Abutment Round, Int. Hex. SP L6mm...
neoWave LS
FDA UDI
XENIX MEDICAL LLC·00818345023970·PADDLE SPREADER, 14MM
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0102140·Shaver, Open 14mm
AutoPulse Battery
FDA UDI
Zoll Circulation, Inc.·00849111002769·Box containing Nickel-metal Hydride (NiMH) batt...
FIRSTSAVE BIPHASIC MODEL #9200 AND 9210
FDA 510(k)
FDA Class 3
·Cardiovascular
MEDIAL ROTATION KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD LUER-LOK¿ SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 14, 2022
PINNACLE SECTOR II CUP 58MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 5, 2013
MATRIX DISTRACTOR RACK
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code LXH·April 22, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·April 27, 2011
AFFINITY 4
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code HDD·June 30, 2008
ASPHERE M SPEC 11/13 40 +0
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 12, 2013
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 12, 2013
ENDOPATH*MULTIFEED STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 19, 2019
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
FDA Enforcement
Class II
·Terminated·Biocare Medical, LLC·November 18, 2015