25 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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iCodeConnect
FDA 510(k)
FDA Class 2
·Anesthesiology
Prodent
FDA UDI
Prodent Dental Technology (Shenzhen) Co., Ltd.·06970553800031·
RESTORIS
FDA UDI
MAKO SURGICAL CORP.·00848486020071·MCK BASEPLATE TEMPLATE (SIZE 7 LM/RL)
Prodent
FDA UDI
Prodent Dental Technology (Shenzhen) Co., Ltd.·06970553800058·
N/A
FDA UDI
GEORGE TIEMANN & CO.·B5821601270·FORCEPS
OsteoMed
FDA UDI
OSTEOMED LLC·00845694032643·1.7mm Drill/Countersink Combo, Short, Manual
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962154441·GERALD BIPOLAR BAYONET FORCEPS, 6 1/2"
HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
ELI 230 ELECTROCARDIOGRAPH
FDA 510(k)
FDA Class 2
·Cardiovascular
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 6, 2016
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 12, 2017
CATHETER MOUNT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZO·September 6, 2016
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code NPT·June 10, 2013
VASOVIEW HEMOPRO 2 EVH SYSTEM
FDA Adverse Event
Malfunction
·MAQUET CARDIOVASCULAR, LLC·Product code GEI·June 2, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008
TFNA FEM NAIL Ø10 R 125° L320 TIMO15
FDA Adverse Event
Injury
·OBERDORF : SYNTHES PRODUKTIONS GMBH·Product code HSB·February 7, 2018
10MM/125 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 21, 2018
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·January 4, 2017
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·July 29, 2020
MEVION S250i, MEVION S250; Proton Radiation Treatment System
FDA Enforcement
Class II
·Terminated·Mevion Medical Systems, Inc.·July 1, 2020