12 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUBi Water Based Personal Lubricant
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114247·VECTIS 2-HOLE 4MM 25GA (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM
Oph. Cystotomes
FDA UDI
KATENA PRODUCTS, INC.·00841668113677·CYSTOTOME STRAIGHT 27GA
EHC400 DESKTOP PATIENT STATION; ECH600 CARE PROVIDER STATION
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOSCOPIC LASER DELIVERY SYSTEM-LASERTX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT CO.·Product code IRT·October 9, 2008
VIRTUOSO VR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 11, 2011
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·July 2, 2013
Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714
FDA Enforcement
Class III
·Ongoing·Young Dental Manufacturing I, LLC·December 28, 2022
ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, ATAR D-RL DISPOSABLE, ATAR D-MDTL DISPOSABLE, ATAR D-MDTS, ATAR D-R1 DISPOSABLE, ATAR D-R NP DISPOSABLE, ATAR D-MDT2, ATAR D-MDTR, ATAR D-R D2P, ATAR D-R T4P, ATAR D-R X2, ATAR D-V2, ATAR D-IS1-2PACE, PACE 101H, PACE 203H WITH ATAR D-MDTS, PACE 203H, PACE 101H WITH ATAR D-T, PACE 300, XI.D-A, DARK BLUE, DISPOSABLE, XI.D-V WHITE DISPOSABLE, XI.D-MDT DISPOSABLE 30 CM, XI.D-T DISPOSABLE, XI.D-RL, XI.D-R DISPOSABLE, 53912D - MDTS ATAR DISPOSABLE Cable is intended to connect an electrode/lead from a patients or another cable to a diagnostic machine or an external pacemaker
FDA Enforcement
Class I
·Terminated·Oscor, Inc.·July 19, 2017
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