21 results · 20ms · Sources: EU EUDAMED, US FDA

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FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT

FDA 510(k)
FDA Class 2 ·Immunology

Closed Wound Suction

FDA UDI
C. R. Bard, Inc.·00801741049620·ReliaVac 100 Closed Wound Suction Evacuator, Lo...

AS1 Dr./Asst Rear Delivery

FDA UDI
Engle Dental Systems, LLC·00850043433033·Wall mount 12 o'clock rear delivery dual purpose

SOLIDEA

FDA UDI
CALZIFICIO PINELLI SRL·08300496070900·MISS RELAX 140 OPEN TOE, SIZE S, NERO, GRADUATE...

Tetra-Net

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138103276·TETRA-NET ELASTIC DRESSING RETAINER SIZE 8

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702368789·ELVAREX 3/KNEE HIGH/OPEN TOE/GREY

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702407655·Elvarex 2/Knee High/Slant-Open Toe/Dotted 2,5 c...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702245387·Elvarex 2/Thigh High/Open Toe-Elephantiasis-Ver...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702542639·ELVAREX FORTE 3/KNEE HIGH/PROFILE-SLANT-CLOSED ...

STS-T LITHOTRIPTER, MODEL STS-T

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

2010 RACK ELECSYS

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·July 6, 2007

EPIDURAL CATHETERIZATION KIT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020

MEDSTONE LITHOTRIPTOR

FDA Adverse Event
Malfunction ·HEALTHTRONICS, INC.·Product code LNS·June 12, 2017

EPIDURAL CATHETERIZATION KIT

FDA Adverse Event
Malfunction ·ARROW INTERNATIONAL INC.·Product code BSO·April 30, 2020

INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 22, 2013

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 9, 2014

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

Sternal Valve Retractors With Atrial and Aortic Rakes; Models SRCL-1, SRCL-AR, SRLP-1, SRLP-AR, ATR-1, ATR-AR, CSR-1 and CSR-AR. For use in cardiac surgery.

FDA Enforcement
Class II ·Ongoing·Genesee BioMedical, Inc.·June 6, 2018

Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024