2,841 results · 32ms · Sources: EU EUDAMED, US FDA

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SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

FDA 510(k)
FDA Class 2 ·Cardiovascular

OsteoMed

FDA UDI
OSTEOMED LLC·00845694001069·2.0mm x 14mm MMF Auto-Drive Screw

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193102238·EVOS Rotate HA PEEK 14mm x 12mm x 30mm Flat, 5°...

DELTA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252496793·Delta 1.7mm Triangular plate - 30mm

Micasept Fenestrated Grasping Forceps

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896118218·Micasept Fenestrated Grasping Forceps Rhombic C...

Minuteman

FDA UDI
Spinal Simplicity, LLC·M9432000920140·Insertion Adaptor, Extended, Sz. 14mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694062985·2.0 MMF x 14mm Screw Sterile Qty 5

N LATEX IGM

FDA 510(k)
FDA Class 2 ·Immunology

MODIFICATION TO BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

CURRENT RF DR

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014

SETROX S 53

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·May 3, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 18, 2011

OT PING ENHANCED METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 31, 2014

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·December 31, 2014

ROUND BLAKE HUBLESS SILICON DRAINS - 3/4 FLUTED

FDA Adverse Event
Injury ·ETHICON INC.·Product code KOG·July 7, 2015

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·January 21, 2014

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 6, 2014

Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery, endodontics and implantology.

FDA Enforcement
Class II ·Terminated·Nobel Biocare Usa Llc·November 20, 2013

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·July 17, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2014