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

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STRYKER ADEL BASSINET

FDA 510(k)
FDA Class 2 ·General Hospital

SURGISTAR

FDA UDI
SURGISTAR, INC.·00878799004185·

SURGISTAR

FDA UDI
SURGISTAR, INC.·00878799004833·

Nexxis

FDA UDI
Barco NV·05415334002074·4K ENC BUNDLE OL

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600121·Mand. 2. Molar band W-Fit left 12

SIGMA

FDA UDI
DEPUY (IRELAND)·10603295232018·SIGMA FEMORAL CRUCIATE RETAINING CEMENTED 2 RIGHT

FRIADENT®

FDA UDI
Dentsply Implants Manufacturing GmbH·07392532233944·Silicone Ring white for Matrix (5 pieces)

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600120101·Mand. 2. Molar band W-Fit left 12

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600120501·Mand. 2. Molar band W-Fit left 12

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

N.A.

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89600120051·Mand. 2. Molar band W-Fit left 12

Accessories, Soft Lens Products

FDA Pre-Market Approval
FDA Class 2 ·REFRESH CL(TM)/LUBRICATING AND REWETING DROPS

O-pel Laser and families of probe delivery devices

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

CLIRPATH TURBO PERIPHERAL CATHETERS

FDA 510(k)
FDA Class 2 ·Cardiovascular

NexGen® Legacy®

FDA UDI
Zimmer, Inc.·00889024000964·

NexGen® Legacy®

FDA UDI
Zimmer, Inc.·00889024000957·

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·February 13, 2013

ARCHITECT C8000 SYSTEM

FDA Adverse Event
Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·January 13, 2011

MDA ASSEMBLY

FDA Adverse Event
Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013

LPS-FLEX PRECOAT FEMORAL B-R LPS-FLEX PRECOAT FEMORAL C-L LPS-FLEX PRECOAT FEMORAL C-R LPS-FLEX PRECOAT FEMORAL D-L LPS-FLEX PRECOAT FEMORAL D-R LPS-FLEX PRECOAT FEMORAL E-L LPS-FLEX PRECOAT FEMORAL E-R LPS-FLEX PRECOAT FEMORAL F-L LPS-FLEX PRECOAT FEMORAL F-R LPS-FLEX PRECOAT FEMORAL G-L LPS-FLEX PRECOAT FEMORAL G-R LPS-FLEX PRECOAT FEMORAL H-L LPS-FLEX PRECOAT FEMORAL H-R¿ LPS-FLEX POROUS FEMORAL E-R This device is indicated for patients with severe knee pain and disability¿

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018