24 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BURR HOLE COVER, MODEL XX
FDA 510(k)
FDA Class 2
·Neurology
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001096·artVeneer life lower anteriors, UIL, A3
Epredia
FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214674·Cassettes are designed to contain incised tissu...
Synergy Disc Instruments
FDA UDI
Synergy Spine Solutions Inc·M67091000010960·Pilot Cutter, Large, 6mm
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
FDA 510(k)
FDA Class 2
·Immunology
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·February 12, 2026
CS100
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·August 22, 2014
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·November 30, 2007
GEMSTR 7 THPY ALT ST
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 5, 2011
PELVICOL 2CM X 7CM 1.0MM
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·March 5, 2013
3D KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·February 16, 2011
INTRAFIX SCREWS, 8-10MM X 30MM
FDA Adverse Event
Injury
·DEPUY MITEK·Product code MBI·February 22, 2008
EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
FDA Adverse Event
Injury
·COVIDIEN·Product code NIP·September 12, 2024
FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·March 19, 2014
CS100,ENGLISH,NON-UTS,DOM
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·April 12, 2023
Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3
FDA Recall
Terminated
·Stereotaxis Inc·Product code NFN·January 27, 2004
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013