38 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
Bur PM2-70 80K FC Ø0.5 St
FDA UDI
Bien-Air Surgery SA·17630055504309·
M.I.S INTERNAL FEMOROPOPLITEAL CAROTID ARTERY CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921004750·M.I.S INTERNAL FEMOROPOPLITEAL CAROTID ARTERY C...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450177990·
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476682·
Femoral Cutting Block
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215041120·
D/C CORE MATERIAL
FDA 510(k)
FDA Class 2
·Dental
BRACHYSEED
FDA 510(k)
FDA Class 2
·Radiology
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, MEDIUM, 12°
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·September 4, 2024
UNKNOWN IV CATHETER
FDA Adverse Event
Injury
·BD (SUZHOU)·Product code FOZ·January 13, 2016
ACCU-CHEK ® SPIRIT
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·May 8, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TYCOHEALTHCARE·Product code BTR·May 17, 2011
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 12°, STERILE, SINGLE USE
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·May 24, 2023
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE, LARGE, 30°, STERILE, SINGLE USE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 6, 2023
HF-RESECTION ELECTRODE, LOOP
FDA Adverse Event
Injury
·OLYMPUS WINTER & IBE GMBH·Product code FAS·June 2, 2023
CPS TIB SPINDLE LT 12X37X42MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 16, 2019
HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·June 12, 2024
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).
FDA Enforcement
Class II
·Terminated·CME America, LLC·December 9, 2020