23 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PREMIER C. DIFFICILE GDH
FDA 510(k)
FDA Class 1
·Microbiology
Hohmann Retractor 8mm Width
FDA UDI
Osteocentric Technologies, Inc.·00816950028519·Hohmann Retractor 8mm Width
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04064279009542·
Marienfeld Superior
FDA UDI
Paul Marienfeld GmbH & Co. KG·04250317328632·
INTREPED, Intraosseous Fusion Device
FDA UDI
Auxano Medical LLC·00850055649026·INTREPED 06x20 implant
Leva® Anterior Interbody System
FDA UDI
Spine Wave, Inc.·10840642112528·Modular Spacer, 26 mm (W) x 26 mm (L) x 13 mm (...
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed
Responsive Orthopedics Total Knee Arthroplasty System
FDA UDI
RESPONSIVE ORTHOPEDICS, LLC·00841973100652·Poly Insert CR, Size 6, 20mm
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
KENSTONE METAL·Product code ITJ·July 20, 2012
ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·September 28, 2011
QUATTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
UNKNOWN LUMBAR IMPLANT
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·April 11, 2022
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012