23 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507256·
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108696455·Bone Profiler Post Implant Kit
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699005·Titanium Angulated Abutment Internal Hex Slim K...
TiWAVE L Lumbar Cage System
FDA UDI
Kalitec Direct LLC·B07323K0101160·Distractor, Smooth Paddle, Lordotic, 16mm
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0101160·Distractor, Smooth Paddle, 16mm
LifeBand® Load-distributing Band
FDA UDI
Zoll Circulation, Inc.·00849111001601·Single-use chest compression band. (1 per pack...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197192415·Ferreira Style Breast Retractor
70x16m...
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
FDA 510(k)
FDA Class 2
·Radiology
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NITINOL TC ELECTRODE
FDA Adverse Event
Malfunction
·COSMAN MEDICAL·Product code GXI·August 29, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2025
PRECISION SPECTRA ?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 15, 2025
EMAX 2 PLUS MOTOR
FDA Adverse Event
Malfunction
·THE ANSPACH EFFORT, INC.·Product code HBC·April 15, 2013
ACRYSOF IQ TORIC
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·April 22, 2011
ACCU-CHEK COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 3, 2008
CIDEX OPA SOLUTION
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code MED·April 14, 2016
ElectroMist product codes: 36-3310-25 - Product Usage: Electrode conductivity spray solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
Alpha Conducting solution product codes:3310-15 ACS - Product Usage: Electrode conductivity spray solution.
FDA Enforcement
Class II
·Terminated·Pharmaceutical Innovations, Inc.·July 24, 2019
ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code MIH·August 8, 2018