21 results · 24ms · 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.

CA 125 II CALSET II

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N/A

FDA UDI
TETRA MEDICAL SUPPLY CORP.·00614138109551·VINYL CAST BOOT, OPEN, MEDIUM

Accent Buccal Tube

FDA UDI
ORMCO CORPORATION·00889989053661·ACCENT B/T 5SGL 2ND NDX -10TX18 UR

INTREPED, Intraosseous Fusion Device

FDA UDI
Auxano Medical LLC·00850055649149·INTREPED 12 Tap

OsteoMed

FDA UDI
OSTEOMED LLC·00845694038775·2.0mm 3 Hole Lozenge Straight Reduction Plate, ...

Reef TA

FDA UDI
Seaspine Orthopedics Corporation·10889981193614·Interbody, 11mm x 40mm x 11mm, 20 deg

Reef TA

FDA UDI
Seaspine Orthopedics Corporation·10889981208721·Trial, 11mm x 40mm x 11mm, 20 deg

Reef TH

FDA UDI
Seaspine Orthopedics Corporation·10889981201609·Interbody, 11mm x 40mm x 11mm, 20 deg

X SERIES

FDA UDI
Zoll Medical Corporation·00847946030056·X SERIES ADVANCED, 3/5 LEAD, SPO2, SPCO, SPMET,...

X SERIES

FDA UDI
Zoll Medical Corporation·00847946059699·X SERIES ADVANCED, MONITOR/DEFIBRILLATOR, 3/5 L...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694064545·2.0 System 3 Hole Lozenge Straight Medium Plate...

SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA, YYY=LENGTH-IN MM)

FDA 510(k)
FDA Class 2 ·Orthopedic

TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2024

Widex

FDA UDI
Widex A/S·05706069605723·Widex UNIQUE U-FP (Silver white ) 440, Telecoil...

Widex

FDA UDI
Widex A/S·05706069594799·Widex UNIQUE U-FM (Silver white ) 440, RC coil

TRILOGY 100

FDA Adverse Event
Malfunction ·RESPIRONICS INC.·Product code CBK·May 29, 2013

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·June 25, 2011

PRECISE OTW NITINOL STENT

FDA Adverse Event
Injury ·CORDIS DE MEXICO·Product code NIM·August 28, 2008

BD MAX¿ ENTERIC BACTERIAL PANEL

FDA Adverse Event
Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·October 12, 2023