412 results
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12ms
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Sources: EU EUDAMED, US FDA
SmartVest
FDA UDI
ELECTROMED, INC.·B102070124S9990·Supplement Kit (Custom International)
OSE
FDA UDI
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC·00810042124226·Nickel Titanium Open Coil Spring .014 x .036 - 15"
ZZZ
FDA Adverse Event
Injury
·HSINER CO., LTD.·Product code BZD·June 27, 2017
SYNCHRONY
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·October 22, 2024
ZZZ-PAP
FDA Adverse Event
Injury
·PROBASICS BY PMI·Product code BZD·November 19, 2009
ALWAYS ZZZ DISPOSABLE OVERNIGHT PERIOD UNDERWEAR LARGE
FDA Adverse Event
Injury
·PROCTER & GAMBLE CO.·Product code NUQ·February 23, 2026
GORE EXCLUDER ZZZ ENDOPROSTHESIS
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES·Product code MIH·July 1, 2013
Evo Medical Comfort PAP, CareFusion PureSom, and ProBasics Zzz-Pap Style
FDA UDI
SUNSET HEALTHCARE SOLUTIONS, INC.·00848530036003·Evo Medical Comfort PAP, CareFusion PureSom, an...
Evo Medical Comfort PAP,CareFusion PureSom,and ProBasics Zzz-Pap Style
FDA UDI
SUNSET HEALTHCARE SOLUTIONS, INC.·00848530035600·Evo Medical Comfort PAP, CareFusion PureSom, an...
Evo Medical Comfort PAP,CareFusion PureSom,and ProBasics Zzz-Pap Style
FDA UDI
SUNSET HEALTHCARE SOLUTIONS, INC.·00848530035860·Evo Medical Comfort PAP, CareFusion PureSom, an...
REAL RESPIRATORY BACTERIAL PANEL 2 (B. pertussis, B. parapertussis, B. holmesii) (Code/código: 5.182.XXX.88.ZZZ)
Device
EU IVDR
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Eu Ivd Class B
·OPERON, S.A.·On the market·1 country
Evo Medical Comfort PAP,CareFusion PureSom,and ProBasics Zzz-Pap Style Foam
FDA UDI
SUNSET HEALTHCARE SOLUTIONS, INC.·00848530035631·Evo Medical Comfort PAP, CareFusion PureSom, an...
Evo Medical Comfort PAP,CareFusion PureSom,and ProBasics Zzz-Pap Style Foam
FDA UDI
SUNSET HEALTHCARE SOLUTIONS, INC.·00848530035624·Evo Medical Comfort PAP, CareFusion PureSom, an...
CAPSURE SENSE LEAD MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO VILLALBA·Product code DTB·September 30, 2025
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·January 25, 2018
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOLTON MEDICAL, INC.·Product code MIH·June 3, 2022
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 25, 2013
CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
FDA Recall
Terminated
·Invision Technologies Inc·Product code ZZZ·October 7, 2005
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
FDA Recall
Terminated
·Compass Health Brands (Corporate Office)·Product code BZD·June 18, 2018
Sterile Procedural Trays, labeled as the following: a. AV SHUNT CDS b. ZALE V-P SHUNT CDS c. NEURO CDS-LF d. MAJOR NEURO e. NEURO PACK-LF f. CUSTOM NEURO PACK-LF g. NEURO PACK-LF h. NEURO PACK-LF i. NEURO PACK-LF j. NEURO PACK-LF k. NEURO/LAMINECTOMY BASIN PK-LF l. U H S NEURO PACK SC m. NEURO PACK-CELEBRATION n. NEURO PACK o. NEURO BASIN PACK-LF p. NEURO PACK q. MAJOR NEURO PK-LF r. NINOR NEURO PK-LF s. NEURO VP SHUNT/VAGAL NERVE-RF t. NEURO PACK-LF u. NEURO PACK v. CRANIOTOMY w. PEDIATRIC NEURO PACK x. NEURO MATRIX PACK y. ACOUSTIC NEUROMA PACK-LF z. MAJOR NEURO PACK-LF aa. SCRIPPS SW NEURO PACK-LF bb. NEURO PACK cc. GENERAL PACK dd. NEURO PK ee. NEURO PACK ff. NEURO PACK gg. NEURO PACK hh. NEURO PACK-LF ii. NEURO PACK jj. NEURO PACK kk. NEURO PACK ll. NEURO PACK mm. CRANIOTOMY PACK nn. PK, NEURO-MINOR oo. NEURO PACK pp. NEURO PACK qq. NEURO PACK rr. PK, NEURO-MINOR ss. NEURO BASIC tt. NEURO BASIC uu. CRANIOTOMY PACK (CRSJE)227-LF vv. NEURO PACK ww. NEURO PACK xx. NEURO CRANI PACK yy. NEURO PACK zz. NEURO TRAY-LF aaa. NEURO PACK bbb. WH NEURO PACK ccc. RFT ISC-N NEURO PACK ddd. NEURO-LF eee. NEURO PACK fff. NEURO LUMBAR PACK ggg. NEURO FUSION PACK-LF hhh. NEURO CERVICAL PACK iii. NEURO PACK jjj. VP SHUNT PACK kkk. NEURO BASIC PACK lll. NEURO PACK mmm. CHRISTUS CHILDRENS NEURO PK nnn. CHRISTUS CHILDRENS VP SHUNT PK ooo. RF NEURO-SHUNT PACK ppp. NEURO PACK qqq. NEURO PACK rrr. NEURO ST DAVIDS MEDICAL CTR sss. GIO NEURO PACK ttt. NEURO KIT uuu. DISCECTOMY PACK vvv. NEURO PACK www. BASIC NEURO PACK-LF xxx. NEURO PACK yyy. NEURO PACK zzz. NEURO aaaa. NEURO bbbb. FHCW NEURO PACK cccc. NEURO FERREE dddd. NEURO eeee. NEURO PACK CW ffff. NEURO gggg. FHT NEURO hhhh. NEURO BASIC iiii. NEURO LUMBAR jjjj. NCH NEURO kkkk. TAVI llll. CHN OR NEURO mmmm. NEURO PACK-LF nnnn. NEURO-CRANI-LF
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code OJG·November 17, 2022