16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N)
FDA 510(k)
FDA Class 2
·Physical Medicine
Pomee
FDA UDI
POMEE CORPORATION·G15772330700·X- long stitch 6 1/4"
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113714·CYSTOTOME REVERSED FORM 25GA
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524025804·EXTRA LONG STITCH SCI 6.25""
ELMED
FDA UDI
ELMED INCORPORATED·00198506057298·Utility pliers. Slip joint. Tip 10mm wide. Over...
SURGICAL FACE MASK (Ear Loops and Tie-on)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code JJE·November 6, 2014
TRIATHLON PS X3 TIBIAL INSERT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 26, 2011
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 11, 2013
200 MICRON TFL SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code GEX·February 1, 2023
200 MICRON TFL SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code GEX·February 1, 2023
200 MICRON TFL SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code GEX·February 1, 2023
200 MICRON TFL SINGLE USE FIBER
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code GEX·February 1, 2023
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·June 6, 2022
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Enforcement
Class I
·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·May 14, 2025