13 results
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21ms
·
Sources: EU EUDAMED, US FDA
Signature ONE System
FDA 510(k)
FDA Class 2
·Orthopedic
BD Bio-Bag™ Type C
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902615102·BD Bio-Bag™ Type C
Innomed, Inc.
FDA UDI
INNOMED, INC.·00840277126252·Parsley Intraoperative Leg Length Device Assembly
XiVE®
FDA UDI
Dentsply Implants Manufacturing GmbH·07392532224003·Depth Gauge D2.0
Needle Holder
FDA UDI
KATENA PRODUCTS, INC.·00841668108123·CASTROVIEJO NEEDLE HOLDER DELICATE STR
Endo-Model Modular Knee Prosthesis System
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575419104·Proximal Tibial Spacer,Size x-small, incl. flat...
SANARUS VISICA TREATMENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
FDA 510(k)
FDA Class 2
·Microbiology
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·May 2, 2024
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·November 19, 2014
ENDURANT ABDOMINAL STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC CARDIOVASCULAR IRELAND·Product code MIH·September 21, 2011
ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code DQX·August 2, 2013
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026