44 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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AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
*Mini-Heart® Lo-Flo, Continuous Nebulizer,Adult Valve Tee
FDA UDI
WESTMED, INC.·00709078000225·*Mini-Heart® Lo-Flo, Continuous Nebulizer,Adult...
ENDOGATOR Kit
FDA UDI
MEDIVATORS INC.·00677964056918·
MiniHEART™
FDA UDI
SUNMED, LLC·10889483227534·MiniHEART™-LoFlo™ Continuous Nebulizer with IV ...
WEITLANER RETRACTOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896048584·WEITLANER RETRACTOR BLUNT TIPS
Ortho Organizers
FDA UDI
Ortho Organizers, Inc.·00190707054670·.010X.030 12mm NITANIUM® CLOSING SPRING
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197019835·Flexible Biopsy Forceps, oval spoon
900mm ...
N/A
FDA UDI
Doppkon GmbH & Co. KG·04262494461736·Endoscopic Kerrison Punch
D 3.0mm, 90°, WL 200mm
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197019842·Flexible Biopsy Forceps, oval spoon
1200mm...
Monoblock Tibial Trial PS Insert
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215042387·
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
RECONSTITUTION KIT & VIAL CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
M2A-MAGNUM 42-50M TPR INSRT +3
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2013
M2A-MAGNUM MOD HD SZ 46MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2013
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·May 8, 2013
BIOFINITY LENSES (COMFILCON A)
FDA Adverse Event
Injury
·COOPERVISION MANUFACTURING, LTD.·Product code LPM·May 17, 2011
OLYMPUS
FDA Adverse Event
Malfunction
·OLYMPUS AMERICA, INC.·Product code MND·August 5, 2008
PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 20, 2016
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018