21 results · 18ms · Sources: EU EUDAMED, US FDA

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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