26 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964073564·Endo Carry-on Procedure Kit includes Enzymatic ...
Trocar
FDA UDI
SOPRO-COMEG GmbH·04059082005294·
EASYRA ALKALINE PHOSPHATASE, ASPARTATE AMINOTRANSFERASE AND AMYLASE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 2, 2019
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL·Product code GFD·October 25, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 3, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
MICRO DRILL LONG STRAIGHT ATTACHMENT
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·May 18, 2011
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 17, 2013
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 17, 2013
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 17, 2013
SERIES 20000 LEGACY
FDA Adverse Event
Injury
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 17, 2013
MARK II INFLATABLE PENILE PROSTHESIS
FDA Adverse Event
Injury
·MENTOR UROLOGY, INC.·Product code FHW·August 15, 1997
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023
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