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