24 results
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19ms
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Sources: EU EUDAMED, US FDA
SPECIMEX DC
FDA 510(k)
FDA Class 2
·Neurology
Keystone Industries
FDA UDI
Keystone Industries·H66819007401·Pkg/5x1 Ft Clasp Wire 15Ga H/R
DISPOSABLE DOWEL HARVEST TUBE
FDA UDI
Biomet Orthopedics, LLC·00880304401884·
Disposable
FDA UDI
Biomet Orthopedics, LLC·00887868510908·
Printed Pre-Formed Right Cantilever 8mm (Single)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199007400·
Navina™ Classic System Small
FDA UDI
Wellspect AB·07333387026589·Navina Classic Transanal Irrigation. 1 Navina C...
Navina™ Classic System Small
FDA UDI
Wellspect AB·07392532243714·Navina Classic Transanal Irrigation. 1 Navina C...
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
MODIFICATION TO: TSRH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
FDA 510(k)
FDA Class 2
·General Hospital
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·March 6, 2019
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·August 24, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 10, 2016
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 27, 2014
UNKNOWN M2A MAGNUM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 8, 2013
AUTOMATED PD SET W/CASSETTE4 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 16, 2010
Affixus¿ Hip Fracture Nail Right 130¿ 9 mm x 400 mm, Item Number: 814509400
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·July 1, 2010
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016