18 results
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29ms
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Sources: EU EUDAMED, US FDA
COMPUTERIZED ANESTHESIA RECORDING & INFO NETWORK
FDA 510(k)
FDA Class 2
·Anesthesiology
Endodontic Hand Instruments
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668550221·HEDSTROM READY STEEL 21MM 15-40
ReadySteal Hedstrom File
FDA UDI
TULSA DENTAL PRODUCTS LLC·D71668550222·Ready Steal Hedstrom File Size 6855022 Length
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209137558·
PowerBar
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746164866·FIXED FUNCT POWERBAR CLASS II 22MM UNIV 2/PK
AlphaVent
FDA UDI
STRYKER CORPORATION·07613327599497·ALPHAVENT SUTURE ANCHOR 5.5MM BIOCOMPOSITE, SUT...
MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS
FDA 510(k)
FDA Class 1
·Hematology
PATHO DX LATEX AGGLUTINATION STREP B KIT
FDA 510(k)
FDA Class 1
·Microbiology
SPINALPAK(R) STIMULATOR ELECTRODES
FDA Adverse Event
Injury
·EBI, LLC.·Product code LOF·March 14, 2017
SPINALPAK(R) STIMULATOR ELECTRODES
FDA Adverse Event
Injury
·EBI, LLC.·Product code LOF·March 14, 2017
SPINALPAK(R) STIMULATOR ELECTRODES
FDA Adverse Event
Injury
·EBI, LLC.·Product code LOF·March 14, 2017
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 9, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 3, 2012
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
LOGIC CR TIB INSERT SLOPE++, SZ 5, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 17, 2023
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017