21 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT
FDA 510(k)
FDA Class 2
·Anesthesiology
PORTEX GENERAL ANESTHESIA CIRCUITS
FDA Adverse Event
Malfunction
·SMITHS MEDICAL INTERNATIONAL, LTD.·Product code CAI·May 18, 2022
RMO
FDA UDI
Rmo, Inc.·00885797099747·LING RETNR BD 3X3 6 CS WO/INST
RMO
FDA UDI
Rmo, Inc.·00885797099730·LING RETNR BOND 3X3 6 CASE KIT
Natus
FDA UDI
NATUS NEUROLOGY INCORPORATED·00382830020824·P32-STIM POD 1 (A-D)-10' (CR)
Metal Custom Rx
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746103469·BRACKET NARROW TWIN RIGHT LATERAL 022 TQ=+14 A=...
LIFEPAK® 12 defibrillator/monitor
FDA UDI
PHYSIO-CONTROL, INC.·00885074269269·LP12AABCBBBABBBBBABAAAAALP12 MONITOR-DEFIB
EARLE'S BALANCED SALTS (EBSS) NO. 200-2506
FDA 510(k)
FDA Class 1
·Hematology
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3945000025060·Carry case/Charger for 10 WVSMs - Graphite
BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B
FDA 510(k)
FDA Class 2
·Orthopedic
LIFESHIELD ADDITIVE PIERCING PIN
FDA 510(k)
FDA Class 2
·General Hospital
12MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/LEFT-STER
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HSB·March 13, 2013
LOCKING SCREW VARIAX FULL THREAD 2.7MM / L55MM
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS SELZACH·Product code KTT·February 16, 2011
PUMP MMT-512LNAL PRDGM INS CL EN US LN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·February 26, 2008
PRESIDIO 10 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
PRESIDIO 18 - CERECYTE MICROCOIL
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HCG·June 9, 2016
COOK SPECTRUM
FDA Adverse Event
Malfunction
·COOK INC·Product code FOZ·July 5, 2019
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
FDA Recall
Terminated
·Zimmer Inc.·Product code KWS·August 23, 2005
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·March 27, 2013