40 results · 31ms · 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.

PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE

FDA 510(k)
FDA Class 2 ·Ophthalmic

Zimmer

FDA UDI
Preat Corporation·00842092100486·Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin ...

Implant Prosthetics

FDA UDI
Preat Corporation·00842092127353·Zimmer® TSV-compatible 3.5/4.5/5.7mm Guide Pin ...

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA UDI
FX SOLUTIONS·03701037307380·LEFT AIMER PRCT II

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151801·IN-OVATION® C EURO 018 U5-5 CS HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151101·IN-OVATION® C Base Rx 018 UP5-5 CHK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151111·IN-OVATION® C Base Rx 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151811·IN-OVATION® C EURO 018 U5-5 CS-BC HK

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151001·IN-OVATION® C Base Rx 018 U5-5

IN-OVATION® C

FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K100151611·IN-OVATION® C Roncone 018 U5-5 CS BC HK

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACTICOAT FOAM DRESSING

FDA 510(k)
FDA Unclassified ·Unknown

TUFF IMPLANT

FDA Adverse Event
Injury ·NORIS MEDICAL LTD·Product code DZE·January 26, 2025

CRE 18-20MM 8CM F/G

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORK LTD.·Product code KNQ·March 21, 2007

RANGER MONITOR W/SNAPS, LARGE & POWER SUPPLY

FDA Adverse Event
Malfunction ·VERATHON MEDICAL (CANADA) ULC.·Product code CCW·February 14, 2013

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

FDA Adverse Event
Injury ·Product code KDJ·February 24, 2011

RESTORE PRIME

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 19, 2008

Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

FDA Recall
Completed ·Percussionaire Corporation·Product code CBK·September 14, 2020

Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

FDA Enforcement
Class II ·Completed·Percussionaire Corporation·November 15, 2023

LEEP SYSTEM 1000 ESU GEN

FDA Adverse Event
Malfunction ·COOPERSURGICAL, INC.·Product code HGI·September 20, 2021