17 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Power Wheelchair
FDA 510(k)
FDA Class 2
·Physical Medicine
BD BBL™ Simmons Citrate Agar Slants
FDA UDI
BECTON, DICKINSON AND COMPANY·30382902210260·BD BBL™ Simmons Citrate Agar Slants, Package of...
FareTec PST
FDA UDI
FARETEC, INC.·B54122210260·FareTec PST Military, green, soft case
SIMPLEX/SARAL
FDA UDI
PARAMOUNT SURGICALS, INC.·00852647007771·1 LEVEL CERVICAL PLATE 26 MM
S2 FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
FLO-GUARD BREATHING FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
CAPTURE-R READY INDICATOR CELLS
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·October 3, 2013
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
CD HORIZON LEGACY 5.5
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·February 12, 2025
UNIFY ASSURA CRT-D
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·November 3, 2014
OPTI-FREE MULTI-ACTION UNIT DOSE SOLUTION
FDA Adverse Event
Injury
·ALCON - KAYSERSBERG FRANCE·Product code LPN·May 21, 2013
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011
EVO+VISIAN Implantable Collamer Lens, REF:VTICM5_13.7. Phakic Toric Intraocular lens.
FDA Enforcement
Class II
·Ongoing·Staar Surgical Company·December 13, 2023
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365. Product consists of a transseptal needle and obturator.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 24, 2021
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018