20 results · 32ms · Sources: EU EUDAMED, US FDA

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cobas m 511 integrated hematology analyzer

FDA 510(k)
FDA Class 2 ·Hematology

Blue Cross Blue Shield/HealthSmart

FDA UDI
D-M-S HOLDINGS, INC.·00767056180697·BCBS MI- PREMIUM DIGITAL ARM BP

OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018

OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018

FLAATZ 760

FDA 510(k)
FDA Class 2 ·Radiology

REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538

FDA 510(k)
FDA Class 2 ·Cardiovascular

OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018

TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125

FDA Adverse Event
Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·September 14, 2012

OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 19, 2018

OVUM ASPIRATION NEEDLE SINGLE LUMEN

FDA Adverse Event
Injury ·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 22, 2018

BD SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 19, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 3, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·June 4, 2019

ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATIN

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·July 21, 2011

MEDULLARY REAMER Ø8 L385

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HTO·June 15, 2013

ACCESS

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·October 14, 2014

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 24, 2019

SYR 10ML SURESCRUB POSIFLUSH SALINE

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·August 14, 2020

CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

FDA Enforcement
Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 2021

Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377

FDA Enforcement
Class II ·Completed·Philips North America Llc·September 15, 2021