21 results
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18ms
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Sources: EU EUDAMED, US FDA
WAKO(TM) AUTOKIT ALBUMIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Archon
FDA UDI
Nuvasive, Inc.·00887517303318·Archon Screw, 4.0x13mm S.T. Fixed Recon
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403150852·Snowden-Pencer FORCEPS KELLY 14.5CM 5-3/4 inche...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78803131·Mini Sprint Bracket Roth .018" max. 3 right
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78803131001·Mini Sprint Bracket Roth .018" max. 3 right
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78803130051·Mini Sprint Bracket Roth .018" max. 3 right
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR78803130101·Mini Sprint Bracket Roth .018" max. 3 right
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880313220·dentaform® Snap, tooth 46,size 13/Roth 22
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257690·Femoral Augment, Posterior
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257645·Femoral Augment, Posterior
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257669·Femoral Augment, Posterior
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257621·Femoral Augment, Posterior
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880313180·dentaform® Snap Band, tooth 46,size 13/Roth 18
MODIFICATION TO EXPEDIUM SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Apollo TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).
FDA Enforcement
Class II
·Ongoing·Waldemar Link GmbH & Co. KG (Mfg Site)·May 7, 2025
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7) 880-313/21 (Sz. 3-4 - cemented lg), (8) 880-313/22 (Sz. 3-4 - cemented x-lg), (9) 880-315/11 (Sz. 5-6 - cemented sm), (10) 880-315/12 (Sz. 5-6 - cemented md), (11) 880-315/21 (Sz. 5-6 - cemented lg), (12) 880-315/22 (Sz. 5-6 - cemented x-lg), (13) 880-317/11 (Sz. 7-8 - cemented sm), (14) 880-317/12 (Sz. 7-8 - cemented md), (15) 880-317/21 (Sz. 7-8 - cemented lg), (16) 880-317/22 (Sz. 7-8 - cemented x-lg), (17) 880-319/11 (Sz. 9-10 - cemented sm), (18) 880-319/12 (Sz. 9-10 - cemented md), (19) 880-319/21 (Sz. 9-10 - cemented lg), (20) 880-319/22 (Sz. 9-10 - cemented x-lg).
FDA Recall
Open, Classified
·Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany·Product code JWH·April 3, 2025
PINNACLE MTL INS NEUT40IDX58OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 18, 2014
SWIFTLOCK ANCHOR
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS, INC.·Product code LGW·October 20, 2010
VITROS CHEMISTRY PRODUCTS PHBR SLIDES
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·December 19, 2012