24 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Minitube Dentasleeve Protective Barrier Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Syntec-Taichung Non-sterile Bone Plate and Screw Implants
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04719864661307·Cortex Screw φ2.0 x 26 mm
PANALOK
FDA UDI
DEPUY MITEK, LLC·10886705001408·PANALOK Drill Bit 3.5mm
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551110514·HALO, 1203-5 VEST PED0, COOLMAX LINER, 1211-1 X...
ShurFit Interbody Device
FDA UDI
PRECISION SPINE, INC.·00840019936873·Instrument and Implant Tray
Straight Plate, 3.5mm
FDA UDI
I.T.S. GmbH·09120034304712·Straight Plate, 3.5mm, 6-Hole
Spex
FDA UDI
SPEX LIMITED·09420051707290·Spex 2-point hip belt, padded, centre pull with...
CORTAC®
FDA UDI
PMT CORPORATION·00650551143765·SUBDURAL GRID ELECTRODE, PLATINUM, 26 CONTACT, ...
VIDAS LYME IGM
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code LSR·April 22, 2021
APOLLO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FORTADERM WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
KINCISE™ System Acetabular Cup Extraction SST Head 26mm
FDA UDI
Spierings Orthopaedics B.V.·08720254007069·
CORTAC®
FDA UDI
PMT CORPORATION·00650551143772·SUBDURAL GRID ELECTRODE, PLATINUM, 26 CONTACT, ...
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA Adverse Event
Injury
·BIOENTERICS CORPORATION·Product code LTI·October 23, 2008
FLEXICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - SWINFORD·Product code KDJ·August 13, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
BD MICROLANCE¿ HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMI·March 16, 2023
ELECSYS FT3 III
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·December 6, 2021
I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers. 1. Forearm Plate, Curved; Article Numbers: 21604-6, 21604-9. 2. Forearm Plate, Straight; Article Numbers: 21605-11, 21605-6, 21605-9. 3. Straight Compression Plate; Article Numbers: 21105-6, 21105-8. 4. Straight Plate, 1.5mm; Article Numbers: 21104-4, 21104-5, 21104-6, 21104-7, 21104-8, 21104-9. 5. Straight Plate, 2.0mm; Article Numbers: 21101-5, 21101-6, 21101-7, 21101-8, 21101-9, 21101-11, 21101-13. 6. Straight Plate, 3.5mm; Article Number: 21102-6. 7. Straight Plate, 4.5mm; Article Numbers: 21103-8, 21103-11, 21103-10, 21103-11, 21103-12, 21103-13, 21103-8, 21103-9.
FDA Recall
Open, Classified
·I.T.S. GmbH Autal 28 Lasnitzhohe Austria·Product code HRS·January 23, 2026
Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Arjo Inc., Roselle, IL 60172; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff.
FDA Recall
Terminated
·ArjoHuntleigh·Product code FSA·April 27, 2009