34 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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SIGNATURE PLANNER, SIGNATURE GUIDES
FDA 510(k)
FDA Class 2
·Orthopedic
HairCheck-DT (THC)
FDA UDI
Quest Diagnostics·00868586000247·HairCheck-DT (THC) is an ELISA test kit used fo...
HHM
FDA UDI
Oticon A/S·05707131268945·H160, DESIGNRITE 10 WL PLI HHM
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690127871·Modular Knee Stem Pilot 25mm x 75mm
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319720745·Gemini-Mixter Forceps 8" (20.3cm), delicate, fu...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052221·Halsted-Mosquito Hemostatic Forceps
12.5 c...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052245·Halsted-Mosquito Hemostatic Forceps
1x2 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197052252·Halsted-Mosquito Hemostatic Forceps
1x2 te...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197382571·Halsted-Mosquito Hemostatic Forceps
14.0 c...
VLOC9ABSORBABLE WOUND CLOSURE DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
QUEST DIAGNOSTICS HAIRCHECK-DT (THC)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·August 8, 2002
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·May 31, 2013
SYNCHRON CX5 DELTA CLINICAL SYSTEM (C13)
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 27, 2011
8010042-2008-00082
FDA Adverse Event
Malfunction
·Product code CBK·June 19, 2008
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
FDA Enforcement
Class I
·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015