11 results
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17ms
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Sources: EU EUDAMED, US FDA
CENTRAL VENOUS CATHETER DRESSING TRAY
FDA 510(k)
FDA Class 1
·General Hospital
ACUMED
FDA UDI
Acumed LLC·10806378099311·Small Fragment Base Set Lid
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450047675·
M-XX OXYGEN SENSORS
FDA 510(k)
FDA Class 2
·Anesthesiology
HAV-LOK BUNION CORRECTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RETRO LONG-TERM HEMODIALYSIS CATHETER 16F FULL PROCEDURE T
FDA Adverse Event
Malfunction
·C.R. BARD, INC. (BASD)·Product code MSD·February 21, 2014
PFC*SIGMA TC3 FEM LEFT SZ4
FDA Adverse Event
Injury
·Product code JWH·October 24, 2012
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·August 17, 2010
Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharmacy to compound multiple source ingredients into one final solution.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 30, 2018
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 9, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024