28 results · 27ms · 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.

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

Hader

FDA UDI
Preat Corporation·00842092112731·Hader Red Riders- Increased

GE

FDA UDI
Philips Ds North America LLC·00884838065628·High Resolution Wrist Coil (Receive Only)

Lieberman Speculum

FDA UDI
SONTEC INSTRUMENTS, INC.·00192896109162·Lieberman Speculum Temporal Approach 26 Millime...

Personalized Mobile Floss Bus Cards Mint

FDA UDI
PRACTICON, INC.·00723896009314·Dental Floss

Best Medical International

FDA UDI
BEST MEDICAL INTERNATIONAL, INC.·00841365107603·

Sklar®

FDA UDI
SKLAR CORPORATION·10649111377310·TRAY COVER FOR 10-1753

Sklar

FDA UDI
SKLAR CORPORATION·30649111240601·TRAY COVER FOR 10-1753 PACK/12

Sklar®

FDA UDI
SKLAR CORPORATION·30649111101971·COVER FOR 10-1753 - PACK OF 6

MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

EXEL SECURETOUCH PTP SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

STENOSCOP

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 30, 2013

PROFEMUR MODULAR FEMORAL NECK

FDA Adverse Event
Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LWJ·August 7, 2008

INNOVA 2000

FDA Adverse Event
Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 10, 2011

HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710006412

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·June 12, 2024

Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025