19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CORE DISPOSABLE INSUFFLATION TUBING
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257010099·M.3 SOFT OA BRACE, VARUS, RIGHT, MD
RP Standard Healing Abutment, 2.0mm Cuff, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549107788·Healing Caps are intended for placement onto th...
Pedo OnBrace Crown UL6 (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199014130·
Elite®Opti-MIM® Bondable Buccal Tubes
FDA UDI
Ortho Organizers, Inc.·00190707070229·.018 L6R STD OPTI-MIM -25T DB
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
FDA 510(k)
FDA Class 3
·Cardiovascular
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
ENVISTA IOL
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 7, 2015
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·January 8, 2013
SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER SINGLE PIECE FOLDABLE INTRAOCUL
FDA Adverse Event
Injury
·STAAR SURGICAL CO.·Product code HQL·November 3, 2010
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 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