9 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BACTEC 9050 SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
ENDOCLAMP AORTIC CATHETER
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code DXC·June 23, 2006
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
touchTymp
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 14, 2013
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·July 28, 2014
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·January 17, 2011
Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code MAX·February 6, 2009
3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 27, 2018