49 results · 22ms · Sources: EU EUDAMED, US FDA

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STIMLAB

FDA 510(k)
FDA Class 2 ·Cardiovascular

ODYSSEY®

FDA UDI
Microport Orthopedics Inc.·M684K00722001·

LEONE SPA

FDA UDI
LEONE SPA·08033707000822·SOLDERABLE DOUBLE BITE S/STEEL

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702480603·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTED SIL. ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702923827·ELVAREX 4/KNEE HIGH/SLANT-CLOSED TOE/DOTTED 5 ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702545838·Elvarex Forte 3/Thigh High/Slant-Open Toe-Eleph...

Cosmolock

FDA UDI
Kalitec Direct LLC·B07310K0122000·Assembly, Tab Breaker, Extended Tab

CAPELLA

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

1.5T INFINITY TWINSPEED MR SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

UNKNOWN

FDA Adverse Event
Malfunction ·COOK, INC.·Product code DTK·August 21, 2014

UNK

FDA Adverse Event
Injury ·COOK, INC.·Product code DTK·August 20, 2014

UNKNOWN

FDA Adverse Event
Injury ·COOK INC·Product code DTK·August 20, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 23, 2013

ULTRAPRO HERNIA PLUG

FDA Adverse Event
Injury ·ETHICON·Product code FTL·April 28, 2011

CAPSURE SP NOVUS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·February 8, 2023

GUNTHER TULIP VENA CAVA FILTER SET

FDA Adverse Event
Injury ·COOK INC·Product code DTK·April 3, 2026

GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

FDA Adverse Event
Malfunction ·COOK INC·Product code DTK·September 12, 2017

Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.

FDA Enforcement
Class III ·Terminated·Viscot Medical LLC·April 10, 2013

NEEDLE FILTER BLUNT FILL 18X1-1/2

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code GAA·February 28, 2020