21 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR
FDA 510(k)
FDA Class 2
·Ophthalmic
Prodigy Voice Blood Glucose Monitoring System
FDA UDI
Prodigy Diabetes Care, LLC·00384840519008·Prodigy Voice Blood Glucose Monitoring System (...
Ophthalmic Forceps
FDA UDI
KATENA PRODUCTS, INC.·00841668106198·CASTROVIEJO-COLIBRI FORCEPS
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04059993074051·ELVAREX 3/BERMUDA PANTY/WITH SLIP FORM ON BOTH ...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702445862·Elvarex Forte 3/Knee High/Slant-Closed Toe-Elep...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702492453·Elvarex 4/Thigh High/Slant-Open Toe/Dotted 5 c...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702250015·Elvarex 2/Thigh High/Slant-Open Toe-Elephantias...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702458534·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE/DOTTED SILIC...
JOBST Elvarex
FDA UDI
BSN-Jobst GmbH·04019702293760·Elvarex 3/Thigh High/Slant-Open Toe-Elephantias...
ALINITY C CARBON DIOXIDE REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT GMBH·Product code KHS·November 11, 2021
ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST
FDA 510(k)
FDA Class 2
·Immunology
GLUCOSE (HEXOKINASE)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BD BBL¿ TRYPTICASE¿ SOY BROTH
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO.·Product code JSG·August 1, 2019
QUILL SRS
FDA Adverse Event
Other
·SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)·Product code NEW·August 24, 2009
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·March 14, 2011
TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION BASE PLATE INSERTER
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·May 22, 2008
The Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280 is used to transmit patient(s) physiological measurements and data to a monitor.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·April 27, 2016
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024
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