16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OSTEOPAL
FDA 510(k)
FDA Class 2
·Orthopedic
Hi-Torque Proceed™
FDA UDI
ABBOTT VASCULAR INC.·08717648321405·Hi-Torque Proceed 220T Angled Guide Wire w/Hydr...
Graves Speculum Large
FDA UDI
MEDGYN PRODUCTS, INC.·M803030903·Graves Speculum Large 1 3/8" x 4 3/4" (35mm x 1...
FX V135 Shoulder Prosthesis
FDA UDI
FX SOLUTIONS·03701037315392·FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V ...
TR Equipment AB
FDA registration
TR Equipment AB·3 products·🇸🇪 Sweden
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 28, 2018
BD NEXIVA 20 GA X 1 IN SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 7, 2024
BD NEXIVA SINGLE PORT
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·September 18, 2024
SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code NKB·April 2, 2013
RESTORE RECHARGEABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 4, 2011
GE OEC 9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·April 17, 2008
WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the patient in endoscopic surgeries. Distr. by Endoscopy Smith & Nephew Inc. REF Numbers: T0449-01
FDA Enforcement
Class II
·Ongoing·WOM World Of Medicine AG·July 10, 2024
AperFix Femoral Implant Coring Removal Drill, labeled as the following: a. Femoral Removal Coring Reamer 9mm, Model Number CM-7109; b. Femoral Removal Coring Reamer 10mm, Model Number CM-7110; c. Femoral Removal Coring Reamer 11mm, Model Number CM-7111; d. Femoral Removal Coring Reamer 9 mm - Long, Model Number CM-7129; e. Femoral Removal Coring Reamer 10 mm - Long, Model Number CM-7130; f. Femoral Removal Coring Reamer 11 mm - Long, Model Number CM-7131; Orthopedic surgical instrument.
FDA Enforcement
Class II
·Terminated·Cayenne Medical Inc.·August 1, 2018
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015