20 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
BECHERT LENS ROTATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072725·BECHERT LENS ROTATOR BLUNT ANGLED FORKED TIP TI...
HEX-FIX
FDA UDI
Smith & Nephew, Inc.·03596010069344·TITANIUM HALF PIN 4.0MM X 20MM
ArgenZ HT+ 95x14 B1
FDA UDI
ARGEN CORPORATION, THE·D818122700·Dental porcelain/ceramic restoration kit
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702557213·ELVAREX 3/KNEE HIGH/PROFILE-CLOSED TOE-ELEPHANT...
Perfect Fit
FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020230·Cadwell ApneaTrak Pediatric Effort Belt Sensor,...
BECHERT LENS ROTATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896072695·BECHERT LENS ROTATOR BLUNT FORKED ANGLED TIP
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DELUXE MANUAL WHEELCHAIR HW 4000
FDA 510(k)
FDA Class 1
·Physical Medicine
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523101788·L Tibial Baseplate Cemented Keeled Sz 7
ROSENBERG
FDA UDI
The Wells Johnson Company·B458201227000·Cannula, Rosenberg, specify length, diameter an...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523100927·L Tibial Baseplate Cemented Stemmed Sz 7
3I T3® TAPERED IMPLANT 4/3 X 11.5MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·May 20, 2025
LIFEPAK(R) 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code MKJ·July 10, 2015
LIFEPAK® 1000 DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC. - 3015876·Product code MKJ·April 24, 2019
1823260-2015-04462
FDA Adverse Event
Malfunction
·November 9, 2015
ENTERRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LNQ·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 18, 2014
ORTHO SUMMIT SAMPLE HANDLING SYSTEM
FDA Adverse Event
Malfunction
·HAMILTON BONADUZ AG·Product code MMH·June 14, 2011
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
FDA Enforcement
Class II
·Terminated·Neurotherm, Inc.·April 20, 2016