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