10,000 results · 173ms · 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.

IRM INC.

FDA registration
IRM INC.·2 products·🇰🇷 South Korea

I-Rapha View

FDA UDI
IRM Inc·08800184000009·

i-Rapha Solution

FDA UDI
IRM Inc·08800184000023·

GUIDESTAR¿ STEERABLE GUIDING SHEATH

FDA Adverse Event
Injury ·OSCOR INC.·Product code DYB·September 8, 2023

ULYS

FDA Adverse Event
Malfunction ·MICROPORT CRM S.R.L.·Product code MRM·March 26, 2024

IRM ZOE INTERMEDIATE RESTORATIVE MATERIAL

FDA Adverse Event
Injury ·DENTSPLY CAULK·Product code EBF·July 21, 2006

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINCE TECHNOLOGY CENTER·Product code HQC·May 28, 2010

INFINITI VISION SYSTEM OZIL

FDA Adverse Event
Malfunction ·ALCON - IRVINCE TECHNOLOGY CENTER·Product code HQC·April 30, 2010

SERIES TWENTY THOUSAND LEGACY

FDA Adverse Event
Injury ·ALCON - IRVINCE TECHNOLOGY CENTER·Product code HQE·January 17, 2002

ALLEGRETTO WAVE

FDA Adverse Event
Injury ·ALCON - IRVINCE TECHNOLOGY CENTER·Product code LZS·June 16, 2011

SERIES TWENTY THOUSAND LEGACY

FDA Adverse Event
Injury ·ALCON - IRVINCE TECH CTR·Product code HQE·November 15, 2007

PUREPOINT

FDA Adverse Event
Malfunction ·ALCON - IRVINCE TECHNOLOGY CENTER·Product code HQF·August 18, 2010

ITREL 3

FDA Adverse Event
Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 15, 2013

a. DERMA SCIENCES, INC. NG Strip FASTENER, NASAL TUBE IND WRAP(25/BX), Catalog NG25. b. DERMA SCIENCES, INC. Surgitube BANDAGE, GAUZE #2P 7/8"X50YDS DERSCI Catalog GL-242. c. DERMA SCIENCES, INC. Surgilast TUBE NET SZ3 MED 10YDS/EA HAND, ARM, LEG, FOOT SURGILAST Catalog # GL103. d. DERMA SCIENCES, INC. Surgitube & Surgigrip APPLICATOR, SURGITUBE/GRIP METAL SZ3 6" CHLD/ADLT DERSCI Catalog #GL-234.

FDA Enforcement
Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.

FDA Enforcement
Class II ·Terminated·Intuitive Surgical, Inc.·June 11, 2014

Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

FDA Enforcement
Class II ·Terminated·Church & Dwight Inc·August 8, 2012

Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal

FDA Enforcement
Class II ·Terminated·Church & Dwight Inc·August 8, 2012

Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

FDA Enforcement
Class II ·Terminated·Church & Dwight Inc·August 8, 2012

Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

FDA Enforcement
Class II ·Terminated·Church & Dwight Inc·August 8, 2012

Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

FDA Enforcement
Class II ·Terminated·Church & Dwight Inc·August 8, 2012