20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PPS PI PRESSURE INJECTABLE SAFETY HUBER NEEDLE WITHOUT LATERAL INJECTION SITE, PPS PI PRESSURE INJECTABLE SAFETY HUBER
FDA 510(k)
FDA Class 2
·General Hospital
JOBST soSoft
FDA UDI
BSN MEDICAL, INC.·00035664007980·SOSOFT 30-40 MM HG KNEE HIGH BROCADE LARGE SAND...
ArgenZ HT+ 98x12
FDA UDI
ARGEN CORPORATION, THE·D818120261·Dental porcelain/ceramic restoration kit
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017176·Hook Scissors 2.7mm 7 degree down
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017183·Hook Scissors 3.5mm 7 degree down
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197526777·DeMartel Vascular Scissors, curved
6 3/4"...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033367·Lincoln scissor
17.0 c...
ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS
FDA 510(k)
FDA Class 2
·Ophthalmic
PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD
FDA 510(k)
FDA Unclassified
·Unknown
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN DEPUY ACETABULAR LINER
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
HAKIM PROG VALVE INLINE SIPHONGUARD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC, MEDOS S.A.·Product code JXG·June 7, 2011
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 13, 2012
UNKNOWN_NEUROVASCULAR_PRODUCT
FDA Adverse Event
Death
·CONCENTRIC MEDICAL·Product code NRY·December 18, 2012
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015