20 results
·
32ms
·
Sources: EU EUDAMED, US FDA
VAS APPROXIMATOR
FDA 510(k)
FDA Class 1
·Neurology
Bioseal Inc.
FDA UDI
BIOSEAL·00630094298054·Vaginal Speculum Clear Medium, Light Source
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM
FDA 510(k)
FDA Class 1
·General Hospital
CALIPERS, MCGAW SKINFOLD
FDA 510(k)
FDA Class 1
·Anesthesiology
PHARMA-GLOVE
FDA Adverse Event
Malfunction
·Product code IWP·August 12, 2021
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·July 16, 2007
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 16, 2021
COMP LOCKING SCREW 4.75X15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 16, 2021
COMP LOCKING SCREW 4.75X15MM CREW 15MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 16, 2021
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
COMP LOCKING SCREW 4.75X20MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 16, 2021
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
COMP RVRS SHDR GLEN BSPLT +HA
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
ARCOM XL 44-36 STD HMRL BRNG RING
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
COMP RVS CNTRL SCR 6.5X30MM ST 30MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 16, 2021
COMP LOCKING SCREW 4.75X20MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·June 16, 2021
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics, Inc.·March 12, 2025