19 results · 20ms · Sources: EU EUDAMED, US FDA

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TBD, EMPI BUFFERED IONTOPHORESIS ELECTRODED MDL. 3

FDA 510(k)
FDA Class 2 ·Physical Medicine

ENDO-SCRUB®

FDA UDI
MEDTRONIC XOMED, INC.·20681490697761·SHEATH 1912015 5PK 4MM/45DEG XOMED

JuggerKnot Soft Anchors

FDA UDI
Biomet Orthopedics, LLC·00880304516557·

REVELATION DIAMOND

FDA UDI
Ss White Burs, Inc.·D6909120152·REVELATION DIAMOND 801-033C - 5 PACK

ELMED INCORPORATED

FDA UDI
ELMED INCORPORATED·00198506088407·BECKMANN ENDAURAL SPECULUM, CURVED TO THE SIDE ...

Sapphire ULTRA Coronary Dilatation Catheter

FDA UDI
OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955979088·

"2.0" SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036053420·

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120150·Assembly, Screwdriver, Polyaxial, Lockable

PREMIER HB9210 HBA1C ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

Faico Dental Implant System

FDA 510(k)
FDA Class 2 ·Dental

BALFOUR MALLEABLE BLADE

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896011403·BALFOUR MALLEABLE BLADE WITH PROTECTIVE EDGE

CELLEX PROCEDURAL KIT

FDA Adverse Event
Malfunction ·THERAKOS·Product code LNR·May 29, 2014

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 11, 2013

RENAL - DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·December 1, 2010

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·November 22, 2022

BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·October 25, 2023

BD NANO¿ 2ND GEN PEN NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·February 14, 2022

Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

FDA Enforcement
Class II ·Terminated·Superstat Corp·November 28, 2012

Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

FDA Recall
Terminated ·Superstat Corp·Product code LMF·October 24, 2012