31 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
AquaGuide® Ureteral Access Sheath
FDA UDI
C. R. Bard, Inc.·00801741052569·AquaGuide® Ureteral Access Sheath
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046039·PrimaLIF LLIF PEEK Implant, 11mm X 22mm X 35mm,...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197030779·Fomon dissecting scissors
135mm,...
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE,BLUE, PINK)
FDA 510(k)
FDA Class 1
·General Hospital
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 14, 2023
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 18, 2001
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 7, 2022
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·July 21, 2022
AQUAGUIDE® URETERAL ACCESS SHEATH
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (COVINGTON) -1018233·Product code FED·July 19, 2023
PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTP·August 31, 2018
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HRS·April 14, 2015
UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJC·January 5, 2010
SPRINT
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 21, 2013
3DKNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·May 23, 2013
CAPSURE SP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011
LCS MENIS BEARING STD+/10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·August 20, 2008
Cervical Tray Catalog 1089
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022
Lumbar Tray Catalog 1091
FDA Enforcement
Class II
·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022