23 results
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21ms
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Sources: EU EUDAMED, US FDA
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