33 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AEROmini Tracheobronchial Stent System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00721902524974·INSTRUMENT 9181200 UNIVERSAL HANDLE
CARBON FIBER ROD, Ø5.0mm x 200mm
FDA UDI
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665022483·
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702454086·E2/AG/SL-OT-KC/NOP-I-OH/BLU
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668100950·DESMARRES LID RETRACTOR #0
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361626·Integra® Miltex® Desmarres Chalazion Forceps 3-...
OrthoMedFlex
FDA UDI
ORTHOMEDFLEX LLC·M7161111812000·Origin Hip Stem, Standard Offset Collarless, Ce...
PILLCAM EXPRESS VIDEO CAPSULES DELIVERY DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4
FDA 510(k)
FDA Class 2
·Dental
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·May 26, 2023
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 28, 2021
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981330927·Lollipop Trial, Anterior-Angled, 18mm x 12mm x ...
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·February 19, 2015
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 2, 2008
HUDSON REUSABLE MANUAL RESUSCITATION BAG/MASK
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTM·July 7, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·July 31, 2009
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·September 29, 2021
ELECTROSURGICAL GENERATOR "ESG-300"
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code GEI·March 18, 2020
Discovery MR750w 3.0T, whole body magnetic resonance scanner
FDA Enforcement
Class II
·Ongoing·GE Medical Systems, LLC·December 4, 2024