21 results
·
21ms
·
Sources: EU EUDAMED, US FDA
BNF
FDA 510(k)
FDA Class 2
·Orthopedic
ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0
FDA 510(k)
FDA Class 2
·Anesthesiology
RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
FDA 510(k)
FDA Class 2
·Orthopedic
audifon
FDA UDI
audifon GmbH & Co. KG·EADF0217828316312017201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021782831632517201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF0217828316338217201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF0217828316315917201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF0217828316312717201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021782831631317201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF021782831631217201·RITE-TRT
audifon
FDA UDI
audifon GmbH & Co. KG·EADF0217828316338117201·RITE-TRT
SLIDE/FIXED HAMMER 700 GRAMS
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code FZY·March 26, 2013
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·March 17, 2011
QUADRA ASSURA DR CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·August 19, 2014
Y-90 THERASPHERE
FDA Adverse Event
Death
·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 11, 2023
WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NGV·October 8, 2021
Y-90 THERASPHERE
FDA Adverse Event
Injury
·BIOCOMPATIBLES UK LIMITED·Product code NAW·January 11, 2023
DHF 06 HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code KDI·May 22, 2025
CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 (b) 153000005 153000005 (c) 153000010 153000010 (d) 153000020 153000020 (e) 153000030 153000030 (f) 153000050 153000050 (g) 210700050 2107050 (h) 210700102 2107102 (I) 210700202 2107202 (j) 210700302 2107302 (k) 210700402 2107402 (l) 210700502 2107502 (m) 210700602 2107602 Product Usage: Rebreathing Bag is indicated for manual patient ventilation or in connection with anaesthesia apparatus and/or patient ventilators.
FDA Enforcement
Class II
·Terminated·Teleflex Medical Europe Ltd·April 18, 2018