23 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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A-SCAN PLUS CONNECT
FDA 510(k)
FDA Class 2
·Radiology
ArgenZ ST 98x14 ML B3
FDA UDI
ARGEN CORPORATION, THE·D818123349·Dental porcelain/ceramic restoration kit
BACKSTOP CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT)
FDA 510(k)
FDA Class 2
·Ophthalmic
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·June 15, 2023
ROD, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·May 14, 2019
5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 21, 2013
ACCOLADE PLUS TMZF HIP STEM #4
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·September 26, 2014
CORE CONSOLE WITH INTEGRAL IRRIGATION PUMP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 8, 2011
ILIAC SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·October 16, 2019
POLARIS SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·January 8, 2020
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
FDA Enforcement
Class II
·Terminated·Excelsior Medical Corp·June 22, 2016
THREE PEG PATELLA 41MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 26, 2025
CANNULATED TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·December 3, 2020
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 5, 2023
SERVO-I BASE UNIT
FDA Adverse Event
Injury
·MAQUET CRITICAL CARE AB·Product code CBK·December 4, 2023
POLARIS CURVED ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019
POLARIS TRANSLATION SCREW, UNKNOWN SIZE
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code NKB·November 27, 2019
POLARIS CURVED ROD, UNKNOWN
FDA Adverse Event
Injury
·ZIMMER BIOMET SPINE INC.·Product code MNH·November 27, 2019