28 results
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29ms
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Sources: EU EUDAMED, US FDA
GIRAFFE2
FDA 510(k)
FDA Unclassified
·Unknown
ILIZAROV
FDA UDI
Smith & Nephew, Inc.·23596010031314·ILIZAROV DISCLIP-ROUND HOLDS 5MM
...
Medi-First Plus Plastic Strip Bandage
FDA UDI
Medique Products·00347682121334·A flexible band of plastic material, coated on ...
Femoral Notch Reamer 0
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215056414·
COVERIS
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030CS1021330·Trial,14mm x 16mm Lordotic 7°, 7mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1021330·SPIRA®-A Integrated,Trial, 30x34mm, 20° Lordoti...
NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIVESURE BARBITURATES SCREEN TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 24, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 29, 2025
11MM/130 DEG TI CANN TROCH FIXATION NAIL 170MM
FDA Adverse Event
Injury
·SYNTHES USA·Product code HSB·April 25, 2013
FREESTYLE LITE
FDA Adverse Event
Malfunction
·Product code NBW·May 9, 2013
VISAO®
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·September 19, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 19, 2011
28MM DIA COCR MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 26, 2013
ACT ARTIC E1 28MM ID X 38MM OD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·June 26, 2013
28MM DIA COCR MOD HD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDI·June 26, 2013
M2A 38MM MODULAR HEAD STD NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 25, 2012
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganismsand particulate material.
FDA Enforcement
Class II
·Terminated·Stryker Instruments Div. of Stryker Corporation·June 12, 2013