31 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STAXX XDL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
B.BRAUN
FDA UDI
B.Braun Avitum AG·04046964762734·OPTION STAFF CALL SW9.XX
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009595·BELLA STRONG 20-30 MM HG ARMSLEEVE DOT BAND SIZ...
Arena-L®
FDA UDI
SPINEFRONTIER, INC.·00190361038900·Flat Trial Head, 38X28 Lordotic 8°, 15L
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780179061·Integra® Jarit® Endarterectomy Scissors, 6-3/4"...
NeuroStar TMS Therapy System
FDA UDI
NEURONETICS, INC.·00869378000117·
NeuroStar Advanced Therapy System
FDA UDI
NEURONETICS, INC.·00850005944843·NeuroStar Advanced Therapy System, Demo
NeuroStar Advanced Therapy System
FDA UDI
NEURONETICS, INC.·00850005944430·NeuroStar Mobile Console, recertified
NIAGARA® Lateral Access System
FDA UDI
VB Spine LLC·10888857517226·Cranial Caudal Blade, Size 220 mm
WISEBANDS SKIN CLOSURE DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
LEVEEN ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 23, 2024
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·April 30, 2013
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - GUANGZHOU·Product code KDI·September 19, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·May 25, 2011
OASYS MIDLINE OCCIPUT PLATE ASSY MEDIUM
FDA Adverse Event
Injury
·STRYKER SPINE-FRANCE·Product code MNI·May 20, 2013
VAC-PAC
FDA Adverse Event
Malfunction
·NATUS MEDICAL INCORPORATED·Product code CCX·November 13, 2017
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·August 27, 2025
Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026