17 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MAGILL FORCEPS
FDA 510(k)
FDA Class 1
·Anesthesiology
Archon
FDA UDI
Nuvasive, Inc.·00887517303370·Archon Screw, 4.0x19mm S.T. Fixed Recon
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403150883·Snowden-Pencer FORCEPS CRILE 16CM 6-1/4 inches,...
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880319220·dentaform® Snap, tooth 46,size 19/Roth 22
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257966·Femoral Augment, Posterior
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257942·Femoral Augment, Posterior
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257973·Femoral Augment, Posterior
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011880319180·dentaform® Snap Band, tooth 46,size 19/Roth 18
LinkSymphoKnee
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575257959·Femoral Augment, Posterior
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
FDA 510(k)
FDA Class 2
·Ophthalmic
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
SHOWER CHAIR
FDA Adverse Event
Injury
·GUARDIAN·Product code IKX·June 13, 2014
VASOVIEW HEMOPRO EVH SYSTEM
FDA Adverse Event
Injury
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·October 20, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 19, 2012
a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight, 120MM, 1 EACH. Model Numbers: CS-11120-03M, CS-13120-03M, CS-15120-03M, CS-17120-03M. Component. of ELEOS LIMB SALVAGE SYSTEM
FDA Enforcement
Class II
·Ongoing·Onkos Surgical, Inc.·June 4, 2025