25 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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STEAM DOT BLU PROCESS INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
NA
FDA UDI
Smith & Nephew, Inc.·03596010038982·HOKE OSTEOTOME 6.4MM X 127MM
InnoSpire Mini
FDA UDI
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD·00383730002040·Innospire Mini with Battery (UK), 6-pack
StaXx® XDL System
FDA UDI
Spine Wave, Inc.·10840642100952·Cartridge Bi-Convex Lordotic Expandable Implant...
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213032811·Coupling Treatment Tube for Metal Needles (13)
Life Instruments
FDA UDI
Life Instrument Corporation·M930711145300·Ring Curette 3mm Micro Handle 250mm working length
DONJOY PAIN BUSTER
FDA Adverse Event
Malfunction
·DONJOY DJO, LLC·Product code MEB·February 8, 2008
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
FDA 510(k)
FDA Class 2
·Dental
TOOTH SHADE RESIN MATERIAL
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108305·Polyaxial Screw 4.5mm diameter 35mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108329·Polyaxial Screw 4.5mm diameter 45mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108299·Polyaxial Screw 4.5mm diameter 30mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108282·Polyaxial Screw 4.5mm diameter 25mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108312·Polyaxial Screw 4.5mm diameter 40mm length for ...
PRONTO SPOT CHECK PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 9, 2018
ACCESS® 2 IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·October 15, 2011
INFUSOMAT SPACE - US VERSION
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FPA·April 12, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 2, 2011
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