22 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STINGRAY CERVICAL CAGE; SHARK IMPLANT (PLIF); BULL SHARK IMPLANT(PLIF); TIGER IMPLANT (TLIF); GREAT WHITE IMPLANTS(ALIF)
FDA 510(k)
FDA Class 2
·Orthopedic
CoRoent
FDA UDI
Nuvasive, Inc.·00887517635600·CoRoent Ant TLIF PEEK, 10x12x32mm 12°
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872673143·LEVAMED STABILI-TRI ANK SUP BLU L II
JOBST Bella Strong
FDA UDI
BSN MEDICAL, INC.·00035664009663·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113325·PHACO KNIFE 2.8MM ANGLED (BX/5)
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780179078·Integra® Jarit® Potts-Smith Scissors, 7", Super...
OPTIBOND 2
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO PANAVIA F
FDA 510(k)
FDA Class 2
·Dental
HEARTMATE II LVAS
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·April 30, 2013
BUDDE HALO RETRACTOR
FDA Adverse Event
Malfunction
·INTEGRA LIFESCIENCES CORPORATION·Product code GZT·August 27, 2014
ECHELON*FLEX45 ARTICULATING
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 25, 2011
DELTAFILL18 10MM X 40CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020
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
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021