20 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PRESAGE ST2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NA
FDA UDI
Smith & Nephew, Inc.·03596010038975·HOKE OSTEOTOME 4.7MM X 127MM
JOBST Anti-Em
FDA UDI
BSN MEDICAL, INC.·00035664114527·ANTI EM TH S-LO W 6 EN FR ES
InnoSpire Mini
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730002033·Innospire Mini with Battery (AUS), 6-pack
MAXCUT CARBIDE BUR (10/pk) FGSS 57
FDA UDI
SCOTT'S DENTAL SUPPLY L.L.C.·D77811114521·MAXCUT CARBIDE BUR (10/pk) Shape: Striaght Fiss...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448838·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032804·Coupling Treatment Tube for Metal Needles (12)
CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW
FDA 510(k)
FDA Class 2
·Radiology
CAVEX STABISIL
FDA 510(k)
FDA Class 2
·Dental
ARTICULEZE M HEAD 36MM +8.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
UNKNOWN DEPUY LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·May 13, 2011
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
UNKNOWN VLOC PRODUCT
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 23, 2017
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 11061648 SOMATOM go.Sim 11061660 & 11061668 SOMATOM go.Open Pro 11061670 & 11061678 SOMATOM X.cite 11330001 Intended Use: Computed tomography x-ray system
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025