17 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex Virtual Implant Positioning (VIP) System
FDA 510(k)
FDA Class 2
·Orthopedic
PQ Autoclave Pouches (3-1/4" x 10") Clear Film
FDA UDI
PEARSON DENTAL SUPPLIES, INC.·D724P2309041·Pk. of 200
ALEUTIAN® Interbody Systems
FDA UDI
VB Spine LLC·10888857346710·Lordotic Rasp, Size 24x30x15 mm, 10°
TRELLIS-8 PERIPHERAL INFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PALAMED
FDA 510(k)
FDA Class 2
·Orthopedic
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·November 6, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 17, 2013
BD SYRINGE 3ML LL EURO 200 S/C
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 5, 2025
HLC-723 G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·July 26, 2024
G8
FDA Adverse Event
Malfunction
·TOSOH HI-TEC, INC.·Product code PDJ·August 27, 2025
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·May 29, 2024
BD CONVENTIONAL NEEDLE
FDA Adverse Event
Injury
·BECTON DICKINSON, S.A.·Product code FMI·March 13, 2024
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·October 23, 2024
ECHOTIP ACUCORE ULTRASOUND BIOPSY NEEDLE
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FCG·March 12, 2024
SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024
BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020