11 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arrow Epidural Needle KZ-05500-007(Luer); KZ-05500-009 (NRFit)
FDA 510(k)
FDA Class 2
·Anesthesiology
Greenwald Surgical Company, Inc.
FDA UDI
GRACE MANUFACTURING, INC.·10801334008567·Otis Bougie-a-Boule. Mirror finish, stainless s...
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen BRAF V600E RGQ PCR Kit
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
FDA 510(k)
FDA Unclassified
·Unknown
PERFORMER HT/ HANG&GO HT BASIC
FDA 510(k)
FDA Class 2
·General Hospital
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen BRAF V600E RGQ PCR Kit
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·June 18, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·October 8, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
HANG&GO HT BASIC
FDA Adverse Event
Malfunction
·RAND S.R.L.·Product code LGZ·May 15, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024