17 results · 27ms · Sources: EU EUDAMED, US FDA

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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