29 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Alma LipoFlow System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NA
FDA UDI
KEY SURGICAL, INC.·10849771049460·K-Wires, Single diamond, round end, .045-inch (...
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293142·
K-Wire w. lanzet/round end 1.14mm/229mm, 6 pcs./unit
FDA UDI
mahe medical gmbh·EMAHKM712420·K-Wire w. lanzet/round end
1.14mm...
mahe medical GmbH
FDA UDI
mahe medical gmbh·04050659484610·K-Wire w. lanzet/round end _x000D_...
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·November 23, 2022
Ambler Value Line
FDA UDI
AMBLER SURGICAL CORP.·00190660214173·Crile retractor, 4 1/4'', #2, double-ended, 1/4...
GENESIS DM MODEL: 6053000A1
FDA 510(k)
FDA Class 2
·Cardiovascular
DBEST ONE STEP OCCULT BLOOD TEST KITS
FDA 510(k)
FDA Class 2
·Hematology
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·April 4, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 22, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·February 2, 2022
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·COOK VANDERGRIFT INC·Product code ITX·May 11, 2022
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LGD·August 14, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 14, 2013
COULTER LH750 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code GKZ·July 1, 2011
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
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
COOK-SWARTZ DOPPLER PROBE
FDA Adverse Event
Injury
·Product code ITX·May 25, 2021