14 results
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30ms
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Sources: EU EUDAMED, US FDA
TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197304566·AUSTIN Measuring probe(caliper)determine
length...
ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ELECTRO INTERSTITIAL SCAN
FDA 510(k)
FDA Class 2
·Neurology
ONE TOUCH BASIC
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·June 14, 2002
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 26, 2007
MECTACER BIOLOX OPTION BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·August 4, 2016
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 29, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·May 26, 2011
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 5, 2014
Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD
FDA Enforcement
Class II
·Ongoing·Ventana Medical Systems, Inc.·August 28, 2024
AERO LL FIXATION ANCHOR, 50MM
FDA Adverse Event
Malfunction
·STRYKER SPINE-US·Product code OVD·March 25, 2019
DEKA SMARTXIDE² TRIO
FDA Adverse Event
Malfunction
·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·October 31, 2023
PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N 0250282051 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014