13 results
·
28ms
·
Sources: EU EUDAMED, US FDA
PISTON IRRIGATION TRAY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DISPOSABLE DOWEL HARVEST TUBE
FDA UDI
Biomet Orthopedics, LLC·00880304401853·
Disposable
FDA UDI
Biomet Orthopedics, LLC·00887868510878·
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI
FDA 510(k)
FDA Class 2
·Clinical Chemistry
COAXIAL DILATOR SET
FDA 510(k)
FDA Class 2
·Cardiovascular
4F M-I STIFFEN 40CM NT-SS (610366)
FDA Adverse Event
Malfunction
·GALT MEDICAL CORP.·Product code DQX·January 10, 2012
TENKU DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 27, 2014
PROXIMATE*ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 16, 2010
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·January 8, 2013
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
FDA Enforcement
Class II
·Ongoing·Family Dollar Stores, Llc.·August 24, 2022
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
FDA Recall
Open, Classified
·Family Dollar Stores, Llc.·Product code EFW·June 23, 2022
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·June 1, 2016
7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, 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