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Blue Sky Bio, LLC.

FDA UDI
BLUE SKY BIO LLC·00815131029031·BIO | One Stage Hand Piece Implant Driver Long

DML 3000

FDA UDI
QIAGEN SCIENCES INC.·04053228010777·

Driver manual long 15mm

FDA UDI
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD·07290018435823·

Stratum

FDA UDI
Medartis Inc.·00817701025474·STRM Lapidus Dorsal Medial Lt

DIGENE DML 2000 MICROPLATE LUMINOMETER

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NEOTREND-L SENSOR

FDA Adverse Event
Other ·DIAMETRICS MEDICAL, LTD.·Product code CCE·April 27, 2001

PARATREND 7+ SENSOR

FDA Adverse Event
Other ·DIAMETRICS MEDICAL, LTD.·Product code CCE·July 3, 2001

NEOTREND-L SENSOR

FDA Adverse Event
Other ·DIAMETRICS MEDICAL, LTD.·Product code CCE·July 23, 2004

MPACT IMPACTION PLATE DML

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·January 9, 2019

MPACT IMPACTION PLATE DML

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·June 16, 2017

COBAS INTEGRA 400+ CLINICAL CHEMISTRY ANALYZER

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 6, 2007

ATELLICA SAMPLE HANDLER PRIME

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·November 22, 2023

ATELLICA SAMPLE HANDLER PRIME

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·November 22, 2023

ATELLICA SAMPLE HANDLER PRIME

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·November 10, 2023

NEOTREND-L SENSOR

FDA Adverse Event
Other ·DIAMETRICS MEDICAL, LTD.·Product code CCE·October 8, 2004

ISYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·September 23, 2008

AERIS

FDA Adverse Event
Malfunction ·BRYAN MEDICAL, INC·Product code EOQ·January 15, 2016

CATHETER, SPINE-INTRADISCAL

FDA Adverse Event
Malfunction ·SMITH & NEPHEW INC., ENDOSCOPY DIVISION·Product code LNY·November 12, 2004

CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·October 15, 2019

A&E MEDICAL CORPORATION DISPOSABLE MYO LEAD (DML)

FDA Adverse Event
Malfunction ·ALTO DEVELOPMENT CORPORATION·Product code IKD·August 10, 2017