73 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.

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136

FDA 510(k)
FDA Class 2 ·Hematology

MiniKut

FDA UDI
DENTAL ENGINEERING LABORATORIES, LLC·00850001745758·MiniKut Retreatment Endodontic Files 20/.06, 25...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X0620250·6mm H x 20mm W x 25mm L x 0 degrees XLIF

Kalitec Universal Instruments

FDA UDI
Kalitec Direct LLC·B07301K0602250·Tray, Base, 2.25"

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X06202580·6mm H x 20mm W x 25mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X062025120·6mm H x 20mm W x 25mm L x 12 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L062025120·6mm H x 20mm W x 25mm L XLIF Trial 12 degree Lo...

RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)
FDA Class 2 ·Ophthalmic

MACROPORE SURGIWRAP (TS)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 8, 2025

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·August 11, 2025

UNKNOWN LIGASURE INSTRUMENT

FDA Adverse Event
Injury ·COVIDIEN MFG DC BOULDER·Product code GEI·February 28, 2025

Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST G02278 CTU14.0-40-ST G02327 CTU14.0-30 G02791 CTU14.0-50-ST G02464 C-CTU14.0-30-ST G02898

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·October 5, 2022

Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0 G17542

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·October 5, 2022

Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534

FDA Enforcement
Class II ·Ongoing·Cook Incorporated·October 5, 2022

FLOGARD

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 16, 2013

CORFLO CUBBY DUAL PORT STANDARD BALLOON

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code KNT·June 13, 2008

9600

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·October 29, 2025

PIPELINE

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·March 14, 2025