18 results · 29ms · Sources: EU EUDAMED, US FDA

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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