42 results · 32ms · 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.

Elite SPK, Compasso, Elite SPK Kit

FDA 510(k)
FDA Class 2 ·Orthopedic

Polysorb

FDA UDI
Covidien LP·10884521176812·Meniscal Stapler Handle

BioHorizons

FDA UDI
BIOHORIZONS IMPLANT SYSTEMS, INC·00847236001803·The External System Surgical Kit

EZ-Fill Root Canal Cement

FDA UDI
ESSENTIAL DENTAL SYSTEMS, INC.·00766054000136·Root Canal Cement Powder Jar/Gel Tube with Bi-D...

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167521605000·

Apelo® / Apelo® MIS

FDA UDI
ATLAS SPINE, INC.·M68111001605000·5.5mm x 500mm MIS Contoured Rod

Vusion CS Plus

FDA UDI
Ortho Development Corporation·00822409025473·16 mm x 5 mm x Parallel

PSL CLASSIC SLIT LAMP

FDA 510(k)
FDA Class 2 ·Ophthalmic

SPEEDY ORTHODONTIC SCREW

FDA 510(k)
FDA Class 2 ·Dental

T:SLIM G5 SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OYC·September 10, 2018

T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 11, 2020

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code LZG·March 3, 2020

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 14, 2022

ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161 (5000 TEST KIT)

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

INFINION CX

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 10, 2023

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Injury ·TANDEM DIABETES CARE·Product code QFG·February 16, 2022

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 6, 2024

Widex

FDA UDI
Widex A/S·05706069724592·Widex UNIQUE U-CIC-M (Light beige S-440 )

Widex

FDA UDI
Widex A/S·05706069724639·Widex UNIQUE U-CIC-M (Clay brown S-440 )

Widex

FDA UDI
Widex A/S·05706069563177·Widex UNIQUE U-CIC-M (Clay brown )