23 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154184065·Bone Screws, emerg., Cross-Pin,self-tap.
EVOS Lumbar Interbody System
FDA UDI
Cutting Edge Spine, LLC·00841193101866·EVOS Straight HA PEEK 9mm x 9mm x 22mm Flat, 5°...
Kalitec Special
FDA UDI
Kalitec Direct LLC·B073DRK0100090·Dilator Sleeve, Screwdriver
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548271·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548257·
InTess C Cervical Cage System
FDA UDI
Kalitec Direct LLC·B07309K0100090·Tamp, Oblique Kicker
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548226·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548233·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548240·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548288·
FOSTER GRANT
FDA UDI
FGX INTERNATIONAL INC.·00193033548264·
KOKO PEAK KP; KOKO PEAK KP+
FDA 510(k)
FDA Class 2
·Anesthesiology
3M ATTEST 290 AUTO-READER
FDA 510(k)
FDA Class 2
·General Hospital
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013
TENDRIL SDX
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·March 13, 2008
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Enforcement
Class II
·Terminated·ITC-Nexus Dx·February 12, 2014
Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon individual patient heparin sensitivity.
FDA Recall
Terminated
·ITC-Nexus Dx·Product code GFO·December 19, 2013
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·April 22, 2015