33 results · 22ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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