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

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MEDTOX OXYCODONE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Marina Medical

FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306813641·Jansen-Gruenwald Nasal Forcep

Klitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0603500·Tray, Base, 3.5"

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE

FDA 510(k)
FDA Class 1 ·General Hospital

XIA LP POLYAXIAL SCREW 6.5 X 40MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

XIA ROD DIA. 6 X 480

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·June 2, 2011

XIA BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·May 2, 2011

XIA SCREW 6, 5 X 40

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNI·May 11, 2011

XIA LP POLYAXIAL SCREW 5.5 X 45MM

FDA Adverse Event
Injury ·STRYKER SPINE-SWITZERLAND·Product code KWP·September 7, 2016

XIA POLYAXIAL SCREW 8.5 X 40MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code MNH·May 2, 2011

XIA BLOCKER

FDA Adverse Event
Injury ·STRYKER SPINE BORDEAUX·Product code KWP·May 11, 2011

PROFEMUR(R) HIP STEM

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·July 10, 2010

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 11, 2013

TECNIS MULTIFOCAL

FDA Adverse Event
Injury ·ABBOTT MEDICAL OPTICS·Product code MFK·April 15, 2011

ONE TOUCH BASIC ENHANCED METER

FDA Adverse Event
Injury ·LIFESCAN, INC.·Product code NBW·June 17, 2008

XIA LP POLYAXIAL SCREW 6.5 X 50MM

FDA Adverse Event
Malfunction ·STRYKER SPINE BORDEAUX·Product code KWQ·September 20, 2011

Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

FDA Enforcement
Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013

Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

FDA Recall
Terminated ·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013