24 results · 35ms · 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.

Dong Hai Xiang Surgical Mask

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

Packed 5D Plus Lite Scanning Unit, RMA

FDA UDI
Align Technology, Inc.·00816063021025·Wand RMAs

NA

FDA UDI
Synthes GmbH·10886982152107·5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE...

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252254041·2.0MP LEFORT I PLATE,3MM ADVANCEMENT,R

COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST

FDA 510(k)
FDA Class 2 ·Cardiovascular

CLAY-PARK LABS, INC. - LUBRICATING JELLY

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

FDA Adverse Event
Injury ·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·October 16, 2008

OT PING METER

FDA Adverse Event
Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

OT ULTRA TEST STRIPS

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 9, 2013

METRIX AIR

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 7, 2019

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

HEMOCCULT® ICT TEST DEVICE

FDA Adverse Event
Injury ·BECKMAN COULTER·Product code KHE·June 3, 2013

MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 22, 2025

Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.

FDA Enforcement
Class II ·Terminated·Beckman Coulter Inc.·August 28, 2013