11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VANCOMYCIN DISK-5 MCG
FDA 510(k)
FDA Class 1
·Microbiology
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221112910·3M™ Victory Series™ Second Molar Bands, 905-151...
I.V. ADMINISTRATION SET CONNECTING DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
INVACARE EXTENDED CARE NURSING HOME BED
FDA 510(k)
FDA Class 2
·General Hospital
MARYLAND BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·January 9, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 22, 2010
ADVANCE(R) II MEDIAL-PIVOT TIBIAL INSERT
FDA Adverse Event
Injury
·MICROPORT ORTHOPEDICS INC.·Product code JWH·July 1, 2014
Spy-Phi Drape only (HH2020) Pack of 20 HH2000 (Sold internationally only). Drape/ UDI: HH2020/20858701006326
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
FDA Enforcement
Class II
·Ongoing·Stryker Corporation·May 13, 2020
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024