18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114193·OLIVE POLISHER 23G ANG 10MM
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114254·CHAMBER MAINTAINER 25GA (PK/10)
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10
3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
FDA 510(k)
FDA Class 2
·General Hospital
SURGASSIST SYSTEM WITH CIRCULAR STAPLER DISPOSABLE LOADING UNIT, MODEL CS21,CS25,CS29,CS33
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RADIUS ROD PERSUADER
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code LXH·October 14, 2008
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 11, 2011
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 2, 2013
TOTAL ASR ACET IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·August 12, 2011
TOTAL ASR ACET IMP SIZE 46
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·August 12, 2011
DEPUY ASR XL FEM IMP SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·August 19, 2013
ASR TAP SLV ADAP 11/13 +6
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KWA·August 19, 2013
DEPUY ASR XL FEM IMP SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD.·Product code KXA·August 19, 2013
CHECK-IT
FDA Adverse Event
Malfunction
·LUCIRA HEALTH, INC.·Product code QJR·November 18, 2022
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 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