16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FDA 510(k)
FDA Class 2
·Dental
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169524811·GUIDE 2150218 O51 SCREW GUIDE 18MM
Oticon
FDA UDI
Oticon A/S·05707131286437·H16V2 TI, MINIRITE 312 WL STG
TraumaOne SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036284633·
TraumaOne SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036136758·
WAVELIGHT SINON
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
FDA 510(k)
FDA Unclassified
·Unknown
CAPTURED HIP SCREW 135 DEGREE 4 HOLE PLATE
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
CAPTURED HIP SCREW LAG SCREW
FDA Adverse Event
Malfunction
·BIOMET TRAUMA·Product code KTT·May 3, 2017
OT VERIO FLEX METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 1, 2015
UNKNOWN HIP ACETABULAR LINERS
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS INC US·Product code KWA·June 6, 2013
MX-PRO R-3 AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·June 10, 2011
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTERICS CORP.·Product code LTI·September 3, 2008
32MM I.D. SIZE D HIGH WALL LINER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LPH·March 31, 2022
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025