21 results · 20ms · Sources: EU EUDAMED, US FDA

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RELIANCE ENDOSCOPE PROCESSING SYSTEM

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

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV

B.BRAUN

FDA UDI
B.Braun Avitum AG·04046963686710·OPTION ACCU DIALOG + SW9.XX

JOBST Bella Strong

FDA UDI
BSN MEDICAL, INC.·00035664009199·BELLA STRONG 15-20 MM HG ARMSLEEVE KNIT WELT SI...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694008914·2 x 4 Hole Compression Right Oblique T Plate

CRYOPEN CRYOSURGICAL SYSTEM, K102214

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

LDL CHOL Reagent Kit

FDA UDI
MEDICA CORPORATION·00386100002206·LDL Cholesterol Reagent Kit for use with EasyRA...

METRO SOFT

FDA 510(k)
FDA Class 2 ·Ophthalmic

SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE

FDA 510(k)
FDA Class 2 ·General Hospital

ALARIS SYSTEM

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·February 3, 2022

THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

FDA Adverse Event
Death ·THORATEC CORPORATION·Product code DSQ·January 23, 2025

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

TANDEM T:SLIM INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·September 17, 2014

CONSTELLATION WITH LASER

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 19, 2011

Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

Model Number L210 PROPONENT SR SL Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021