23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NATURALASE CO2 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bone cutters
FDA UDI
DFS - DIAMON GmbH·04057176162977·Bone cutter FGXL C162 1,6mm
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·00035664103330·FOR MEN 8-15 MM HG KNEE HIGH LARGE WHITE 1 EN F...
N/A
FDA UDI
Smith & Nephew, Inc.·03596010035011·HIBBS OSTEOTOME CURVED 12.7MM
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306802812·Freeman Rake Retractor, 4 Sharp Prongs, 4cm wid...
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776371821·Mueller-Style Phlebectomy Hook, left, size 3
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450231838·
FIAB SPA, MODELS F7244, F7233, F7234, F7277
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CRYOCARE CS SURGICAL SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 7, 2025
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 11, 2015
STRATUS CS
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DAP·November 9, 2015
SMARTSET GHV GENTAMICIN 40G
FDA Adverse Event
Injury
·DEPUY CMW - 9610921·Product code LOD·October 17, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAB·September 23, 2014
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·May 20, 2011
CLOSUREFAST CATHETER
FDA Adverse Event
Injury
·COVIDIEN·Product code GEI·February 6, 2026
DISPOSABLE STERILE HIGH TEMPERATURE ELECTROCAUTERY (HTC) F7244
FDA Adverse Event
Injury
·FIAB SPA·Product code GEI·October 12, 2023
Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Product Usage: Intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator The CUSA Electrosurgical Module (CEM) provides Desiccate Coagulation waveform electrosurgical capability to CUSA Excel handpieces. The CUSA handpiece with the CEM Nosecone works in conjunction with the Force FX generator in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·February 26, 2014
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016