21 results
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38ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
FDA 510(k)
FDA Class 2
·Anesthesiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198895·AK3 Congruent Insert Trial Size 1, 11mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450217849·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450226230·
Gorilla Plating System
FDA UDI
Paragon 28, Inc.·00889795017772·Gorilla, Plate, Med Col Rescue, 2.0mm Thk, 11-H...
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07310K0191110·Dilator, Small
PANORET, MODEL 1000A
FDA 510(k)
FDA Class 2
·Ophthalmic
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 17, 2025
INRATIO
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code GJS·September 27, 2010
PASSPORT 2 MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 16, 2014
AORTIC AP360
FDA Adverse Event
Death
·MEDTRONIC ATS, INC.·Product code LWQ·May 6, 2011
BD RAPID DETECTION OF SARS-COV-2 VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·October 1, 2021
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·October 15, 2025
BD RAPID DETECTION OF SARS-COV-2 VERITOR¿
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code QKP·November 19, 2021
PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·April 23, 2026
LGN PRSFT STEM 10MMX220MM STRT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 19, 2017
LEGION HK HINGE KNEE SYSTEM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KRO·March 15, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012