15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ComfortGel Blue
FDA UDI
Respironics, Inc.·00606959020818·ComfortGel Blue Nasal Mask with Standard Elbow,...
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108690811·Titanium Straight Abutment Internal Hex. SP Ø4....
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306814198·Kocher Hemostatic Forceps, Curved, 1x2 Teeth, 1...
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231818·
PERSONA® Persona SoluTion™
FDA UDI
Zimmer, Inc.·00889024231825·
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
COMPUMEDICS E-SERIES EEG SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
LNOP MP12 PATIENT CABLE
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·May 15, 2015
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 22, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·July 3, 2008
SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·April 26, 2011
Bausch & Lomb Zyoptix XP Epi Separator, packaged 1 per sterile pouch, 10 per carton, Reorder No. 507-0068, RX, for single use only. Ophthalmic surgical accessory. The product is labeled as Manufactured by: Bausch & Lomb Incorporated, St. Louis, MO. The Epi Separator is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.
FDA Recall
Terminated
·Bausch & Lomb Inc·Product code HNO·June 8, 2007