12 results · 28ms · 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.

Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197538343·Ikuta Bone Clamp 8 pointed theet jaw, fo rked c...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197538329·Ikuta Bone Clamp 8 pointed theet jaw, fo rked c...

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197538350·Ikuta Bone Clamp 8 pointed theet jaw, fo rked c...

AT HOME DRUG TESTT, MODEL 9150 T

FDA 510(k)
FDA Unclassified ·Unknown

MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

NEXGEN LPS-FLEX FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER, INC.·Product code JWH·August 10, 2011

ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code NIQ·October 29, 2014

RIATA ST ACTIVE FIXATION

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 8, 2013

EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

FDA Enforcement
Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015