28 results · 34ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

Reform Pedicle Screw System

FDA 510(k)
FDA Class 2 ·Orthopedic

ReLine

FDA UDI
Nuvasive, Inc.·00195377047342·RELINE-O Trial,7mm H Pedicle L-pop

OsteoMed

FDA UDI
OSTEOMED LLC·00845694006415·1.6mm Pilot Drill, OSTEOPOWER

Olympus

FDA UDI
Gyrus ACMI, LLC·00810008185155·ES-IP BASE SYSTEM, SPLIT RACK, THREE ROOM with ...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776165574·MURPHY RETR PRONG SHP -

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·04546540356635·TROCAR

NA

FDA UDI
Stryker Leibinger GmbH & Co. KG·07613154639328·TROCAR FOR 92-62009

Bradshaw Medical Inc.

FDA UDI
Bradshaw Medical, Inc.·00810019930195·BIT, HEXALOBE 10 AO

Insurgical, Inc.

FDA UDI
Insurgical, Inc.·00850056900133·Reprocessed VHP Reciprocating Saw

HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS FOR THE LIMB

FDA 510(k)
FDA Class 2 ·Cardiovascular

XR PRIMER 2

FDA 510(k)
FDA Class 2 ·Dental

NEW CORONA VIRUS NUCLEIC ACID DETECTION KIT

FDA Adverse Event
Malfunction ·PERKINELMER, INC.·Product code QJR·March 5, 2021

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·July 19, 2021

T:FLEX INSULIN DELIVERY SYSTEM

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code LZG·August 13, 2019

L3C3850 - GENTLECATH

FDA Adverse Event
Malfunction ·UNOMEDICAL S.R.O.·Product code GBM·January 4, 2021

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·November 12, 2020

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·October 16, 2019

CADD

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·June 10, 2022

UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

FDA Adverse Event
Other ·BECKMAN COULTER, INC.·Product code MMI·October 1, 2008

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011