20 results
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20ms
·
Sources: EU EUDAMED, US FDA
ONE-CUF
FDA 510(k)
FDA Class 2
·Cardiovascular
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780183624·Integra® Jarit® Cicherelli Rongeur, 6-1/2", 3.6...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776144555·SurgiBit® 3.2mm 3-fluted SQC drill bit, 145mm
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776144579·SurgiBit® 4.2mm 3-fluted SQC drill bit, 145mm
SacroFuse
FDA UDI
SPINEFRONTIER, INC.·00190361036142·SCREW, SOLID WALL, CANNULATED, Ø10MM X 45MM, SA...
TIBIAL NAIL, STANDARD T2 TIBIA 9X300 MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·October 12, 2012
GALIX WINTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Nitrile Glove Powder Free Blue
FDA 510(k)
FDA Class 1
·General Hospital
IMP,TSV,4.1MM,SBM,11.5
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·December 9, 2024
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145014HA0·Thread Implant 3W 4.5 X 14 HA
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145009HA0·Thread Implant 3W 4.5 X 9 HA
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145005HA0·Thread Implant 3W 4.5 X 5 HA
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145011HA0·Thread Implant 3W 4.5 X 11 HA
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145006HA0·Thread Implant 3W 4.5 X 6 HA
Quantum
FDA UDI
QUANTUM BIOENGINEERING LTD.·D825230145008HA0·Thread Implant 3W 4.5 X 8 HA
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
OT VERIO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 1, 2011
SECURE 3 MED/SURG BEDOBS 01/13
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 16, 2013
BLOOD PUMP PU VALVES 10 ML, IN/OUT Ø6 MM
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·May 4, 2023
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
FDA Enforcement
Class II
·Terminated·Zimmer Surgical Inc·November 12, 2014