19 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CaloPix
FDA 510(k)
FDA Class 2
·Pathology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813057766·STERILE CARBIDE BUR RA8
NA
FDA UDI
Stryker Leibinger GmbH & Co. KG·37613154997627·Bone Screws w. increased head,Cross Pin
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981310370·No-Profile Interbody, 4-Hole Faceplate 14mm
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306805950·Vu-Mar XL Speculum -Pederson, Large, 11.5cm x 2...
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250414200·ceraMotion® PZr Press Liner D2, 20 g / dental c...
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL
FDA 510(k)
FDA Class 1
·General Hospital
PLIX
FDA 510(k)
FDA Class 2
·Anesthesiology
NA
FDA UDI
aap Implantate AG·04042409451324·Cannulated Headless Bone Screw 2.5, L 14, TL 4 ...
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DRE·April 6, 2023
ALARIS SYSTEM
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·September 19, 2023
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 3, 2008
PRECISION®
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 15, 2011
E-POLY 36MM +3 MAXROM LINER SIZE23
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code MAY·July 26, 2013
VERSACROSS CONNECT LAAC ACCESS SOLUTION
FDA Adverse Event
Injury
·BAYLIS MEDICAL COMPANY INC.·Product code DXF·April 25, 2023
BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019