49 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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da Vinci SP Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NA
FDA UDI
Synthes GmbH·10886982151759·3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RE...
24M - Shambaugh & Sons - Metal
FDA UDI
Certified Safety Manufacturing, Inc.·00766588121017·24M - Shambaugh & Sons - Metal
Posterior Wall Plate, Extended, Left, Large, PRS Phoenix
FDA UDI
I.T.S. GmbH·09120069818383·
Posterior Wall Plate, Extended, Left Small, PRS Phoenix
FDA UDI
I.T.S. GmbH·09120069818390·
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918158730·Half Drape_60inx44in_Non-sterile_80ea/cs
TLC Uni Knee Meniscal Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215077310·
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CAPILLARYS HEMOGLOBIN HBA1C CAPILLARYS 2 FLEX PIERCING CAPILLARYS HBA1C CONTROLS CAPILLARYS HBA1C C
FDA 510(k)
FDA Class 2
·Hematology
EASYPOINT
FDA Adverse Event
Malfunction
·RETRACTABLE TECHNOLOGIES, INC.·Product code FMI·June 15, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·November 7, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 11, 2023
FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23
FDA 510(k)
FDA Class 2
·Clinical Chemistry
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·December 22, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
RAD-97 PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MWI·October 30, 2023
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder Number 21-2101-00, 21-2101-0100-50, 21-2101-0100-51, 21-2101-0200-02, 21-2101-0200-03, 21-2111-0100-51, 21-2111-0200-02, and 21-2102-51.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code MEA·January 13, 2011
MESH - COMPOSIX KUGEL
FDA Adverse Event
Injury
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·October 24, 2008
FEMORAL NAIL, A/R 12X400 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2011