44 results · 23ms · Sources: EU EUDAMED, US FDA

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NeuroStar Advanced Therapy

FDA 510(k)
FDA Class 2 ·Neurology

Corneal Trephine

FDA UDI
KATENA PRODUCTS, INC.·00841668112939·CORNEAL TREPHINE BLADE8.0MM

GAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm

FDA UDI
W.H. Holden, Inc.·D9282011580·

Life Instruments

FDA UDI
Life Instrument Corporation·M93072011580C0·Custom Cobb Elevator 5/8" (5 3/4" handle)

LOGIQ E10

FDA 510(k)
FDA Class 2 ·Radiology

LIC INSTRUMENT PROCESSING SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

WALLFLEX DUODENAL

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MUM·January 22, 2025

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 29, 2011

PULSE GEN MODEL 103

FDA Adverse Event
Injury ·CYBERONICS INC·Product code LYJ·July 2, 2013

ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

PERITX DRAINAGE BAG

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 3, 2026

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

FDA Enforcement
Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·October 6, 2025

PLEURX DRAINAGE KIT 500ML 10/CS

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code DWM·July 25, 2025

PERITX PERITONEAL CATHETER & STARTER KIT

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code PNG·April 2, 2026