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

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SURECALL LABOR MONITOR

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

ACRY CETTE

FDA UDI
DENTAL MANUFACTURING SPA·08056865013022·

MIRABAY

FDA UDI
Mirabay Orthodontics Corp.·05061075029155·OPTIMAL SYMMETRY ARCHWIRE TRANS THERM PL 0.014 ...

OsteoMed

FDA UDI
OSTEOMED LLC·00845694002882·15mm Right L Plate

Trivicta

FDA UDI
Ortho Development Corporation·00822409123414·Collarless STD Size 2

OneLIF™

FDA UDI
Novapproach Spine LLC·G07001151300020·Starter Trial, Small, 13deg, 7mm AH - 2PH

Perfect Fit

FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020377·Cadwell Disposable Pediatric Effort Belt, 2 pcs

Perfect Fit

FDA UDI
DYMEDIX DIAGNOSTICS, INC.·00817377020384·Cadwell Disposable Adult Effort Belt, 2 pcs

Monkey Rings™ External Fixation System

FDA UDI
Paragon 28, Inc.·00889795116444·Slotted Angled Socket Wrench, 10mm

OsteoMed

FDA UDI
OSTEOMED LLC·00845694063753·1.6 System 15mm Right L Plate Sterile Qty 5

LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.

FDA 510(k)
FDA Class 2 ·General Hospital

SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

WAVEWRITER ALPHA? 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 29, 2025

TPRLC 133 MP TYPE1 PPS HO 17.0

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·April 13, 2020

TERUFLEX BLOOD BAG SYSTEM

FDA Adverse Event
Malfunction ·TERUMO CORPORATION/TERUMO BCT·Product code KSR·May 24, 2013

SNESOR ENLITE

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 19, 2014

ANEURX ABDOMINAL STENT GRAFT SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 10, 2011

CRANIOFACIAL RIGID FIXATION SYSTEM

FDA Adverse Event
Injury ·OSTEOMED·Product code MQN·November 7, 2013

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015