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