20 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
FDA 510(k)
FDA Unclassified
·Unknown
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704293760·
Key Surgical K-Wires and Steinmann Pins
FDA UDI
KEY SURGICAL, INC.·00849771015048·Steinmann Pins, Single diamond, 3 shank end, 5/...
NA
FDA UDI
KEY SURGICAL, INC.·10849771049903·Steinmann Pins, Single diamond, 3 shank end, 5/...
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
NON-CHLORINATED, POLYMER COATED POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES AND PROTEIN LABELING CLAIM OF
FDA 510(k)
FDA Class 1
·General Hospital
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
FDA 510(k)
FDA Class 2
·Cardiovascular
TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
OVUM ASPIRATION NEEDLE SINGLE LUMEN
FDA Adverse Event
Injury
·WILLIAM A. COOK AUSTRALIA, PTY LTD·Product code MQE·April 18, 2018
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
ACCU-CHEK ® MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 14, 2014
FRONT CUTTER
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXZ·June 15, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
TRU CC FEMORAL SIZE 1 LEFT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 15, 2025
INTER-LOCK SCREWDRIVER T25/3.5 HEX/224
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code HXX·June 13, 2024
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
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