18 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIAL2BAG DIRECT CONNECT
FDA 510(k)
FDA Class 2
·General Hospital
Starbond Easy
FDA UDI
S & S Scheftner GmbH·04260207854097·Pulver 30, 5kg
ForPro
FDA UDI
Tng Worldwide, Inc.·00672047000185·Pink Nitrile Exam Glove
Size Medium
100ct
Cancellous Screw, Cannulated
FDA UDI
I.T.S. GmbH·09120034307867·Cancellous Screw, Cannulated, D=4.0mm, L=30m
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319733325·Adair Tenaculum Forceps 6-3/4" (17.3cm)
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046305·PrimaLIF LLIF PEEK Implant, 7mm X 26mm X 30mm, ...
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
MONACO RTP SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 31, 2022
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2025
2520274-2013-03032
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·May 31, 2013
ALARIS PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION CORPORATION·Product code FRN·June 15, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 3, 2014
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
UNID ROD
FDA Adverse Event
Malfunction
·MEDICREA INTERNATIONAL SA·Product code MNI·July 29, 2024
LOGIC CR FEMORAL POR, RIGHT, SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 14, 2019
C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·September 24, 2014
C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·December 11, 2013