20 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

CAPRI Corpectomy Cage System

FDA 510(k)
FDA Class 2 ·Orthopedic

OsteoMed

FDA UDI
OSTEOMED LLC·00845694016056·Spectrum Distraction Tool, Horizontal Adjustment

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Enforcement
Class II ·Completed·Teleflex Medical Europe Ltd·August 25, 2021

RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 170050 b) 170055 c) 170060 d) 170065 e) 170070 f) 170075 g) 170080 h) 170085 i) 170090 j) 170095

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K1100550·Caddie, Misc Screws

N/A

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055001·MTM® NO TRACE (TM) 018 UL/4-4

IN-OVATION® L

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055011·IN-OVATION® L 018 UPPER 6-6

IN-OVATION® L

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K190055101·IN-OVATION® L 018 UL/7-7

BLOOD PRESSURE METER, MODEL CH-609

FDA 510(k)
FDA Class 2 ·Cardiovascular

BONALIVE GRANULES AND BONALIVE PLATES

FDA 510(k)
FDA Class 2 ·Dental

BINAXNOW COVID-19 ANTIGEN SELF TEST OTC 2 TEST PACK

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 30, 2021

STELLARIS ELITE VISION ENHANCEMENT SYSTEM

FDA Adverse Event
Injury ·BAUSCH + LOMB·Product code HQC·March 1, 2022

25 GA POSTERIOR WIDE-FIELD ELITE PACK

FDA Adverse Event
Malfunction ·BAUSCH + LOMB, INC·Product code HQC·December 6, 2019

TENSION FREE VAGINAL TAPE

FDA Adverse Event
Injury ·ETHICON, INC.·Product code OTN·June 14, 2013

SCORPIO TS MOD. TIB. TRAY

FDA Adverse Event
Injury ·STRYKER ORTHOPAEDICS MAHWAH·Product code JWH·July 13, 2011

D-FLEX TRIANGULAR RETRACTOR 80MM 5MM

FDA Adverse Event
Injury ·CAREFUSION·Product code GCJ·August 20, 2014

STELLARIS POWER SUPPLY II

FDA Adverse Event
Malfunction ·BAUSCH + LOMB·Product code HQC·August 1, 2023

UNKNOWN MICROCATHETER

FDA Adverse Event
Injury ·COVIDIEN (IRVINE)·Product code DQY·May 30, 2017

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

FDA Recall
Open, Classified ·TELEFLEX LLC·Product code BTR·May 25, 2023

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

FDA Enforcement
Class I ·Ongoing·TELEFLEX LLC·July 5, 2023