21 results · 23ms · Sources: EU EUDAMED, US FDA

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EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

25GA Curved Illuminating Probe, SMA906

FDA UDI
Peregrine Surgical, Llc·00632307001826·25GA Curved Illuminating Probe, SMA906

25LB CLEAR POLYMER

FDA UDI
Great Lakes Dental Technologies, Ltd.·D7750400180·25LB CLEAR POLYMER

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval
FDA Class 2 ·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS

Kalitec Special

FDA UDI
Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm

Disposable Cuff

FDA UDI
SUNTECH MEDICAL, INC.·10840935106807·

N/A

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613327500523·Patient Tracker Advanced

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710300400180·Tibial Osteotmy Guide, 40mm x 18mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710310400180·Talar Osteotmy Guide, 40mm x 18mm

Intelliguides

FDA UDI
Mios Marketing, LLC·G2710820400180·Zadik Calcaneal Guide, 40mm x 18°

CONTOUR CURVED CUTTER STAPLER CS

FDA Adverse Event
Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GDW·June 13, 2006

SKINGARD POLYCOAT GLOVE

FDA 510(k)
FDA Class 1 ·General Hospital

BRANEMARK NOVUM

FDA 510(k)
FDA Class 2 ·Dental

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

FDA Recall
Terminated ·Cook Inc.·Product code KOB·April 22, 2019

Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774

FDA Enforcement
Class II ·Terminated·Cook Inc.·May 29, 2019

VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

FDA Adverse Event
Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

INFUSE BONE GRAFT DEVICE (RHBMP-2)

FDA Adverse Event
MEDTRONIC INC.·Product code NEK·April 3, 2013

MAHURKAR MAXID 23 CM

FDA Adverse Event
Malfunction ·COVIDIEN·Product code FJS·March 25, 2011

ACCU-CHEK COMFORT CURVE TEST STRIPS

FDA Adverse Event
Injury ·ROCHE DIAGNOSTICS·Product code LFR·May 7, 2008

SALLE PYELOPLASTY STENT SET

FDA Adverse Event
Malfunction ·COOK INC·Product code FAD·July 27, 2017