25 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.

PicoSure Workstation

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

ARTHRO-PIERCE

FDA UDI
Smith & Nephew, Inc.·03596010601377·MTO ARTHRO-PIERCE INSTR 45 L

DG Gel 8 Anti-c

FDA UDI
DIAGNOSTIC GRIFOLS SA·08436583731079·For the determination of human c antigen on the...

Hayden Medical

FDA UDI
Hayden Medical, Inc.·00840319721926·Sheehan Osteotome 6-1/4" (15.6cm), 15mm wide, h...

BOSS Instruments

FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515036390·Stille Osteo, str, 10mm, 6 1/4"

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 24, 2022

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 24, 2022

INTERFUSE T INVERTEBRAL BODY FUSION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

VERDICT -II METHAMPHETAMINE

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BINAXNOW COVID-19 ANTIGEN SELF-TEST

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 8, 2022

GALAXY G3 MINI 1.5MM X 3CM

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·August 13, 2020

RELIANCE 4-FRONT

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·February 3, 2022

SM204 M-SERIES W/BIG WHEEL

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·July 11, 2011

ONE TOUCH PING METER

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code NBW·October 20, 2008

2124215-2013-06838

FDA Adverse Event
Malfunction ·GUIDANT PUERTO RICO BV·Product code NVN·July 8, 2013

FLEXTEND

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code DTB·July 15, 2025

ATTUNE PS RP INSRT SZ8 6MM

FDA Adverse Event
Malfunction ·DEPUY IRELAND - 9616671·Product code NJL·March 14, 2025

SKINTACT

FDA Adverse Event
Malfunction ·LEONHARD LANG GMBH·Product code MKJ·January 13, 2022

Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.

FDA Enforcement
Class II ·Ongoing·Windstone Medical Packaging, Inc.·October 16, 2024

DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·April 19, 2023