37 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
FDA 510(k)
FDA Class 2
·General Hospital
GammaPro High Sensitivity Probe
FDA UDI
Kubtec·B619GPROHISPROBE0·GammaPro High Sensitivity Probe used for wirele...
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489105619·PowerChem Neoprene Exam Gloves, Extra Small
GammaPro High Sensitivity Probe
FDA UDI
Kubtec·B619K0019C01UW0·GammaPro High Sensitivity Probe used for wirele...
GRADIA®
FDA UDI
Gc America Inc.·D0470019011·GRADIA® gum Modifier (GM32), 2.4 mL
GRADIA®
FDA UDI
Gc America Inc.·14548161393232·GRADIA® gum Modifier (GM32), 2.4 mL
JOBST Custom Seamless Soft
FDA UDI
BSN-Jobst GmbH·04059993138982·CUSTOM SEAMLESS SOFT 2/AG-HT ONE LEG PANTY/CLOS...
No Mix30
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746007781·NO MIX:30 ADHESIVE 14 GMS
Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-0029-901, 6650-0080-901, 6650-0032-901, 6650-0077-901, 6650-001-901, 6650-0006-901, 6650-0129-901, 6650-0063-902, 6650-0130-901, 6650-0082-902, 6650-0061-902, 6650-0131-902, 6650-0034-902, 6650-0104-902, 6650-0066-902, 6650-0042-902, 6650-0143-901, 6650-0148-902, 6650-0152-901, 6650-0107-902, 6650-0136-902, 6650-0060-902, 6650-0056-902, 6650-0043-902. Labeled as OMNIBED ENG EBASE S-HUMID, GIRAFFE OMNIBED, GIRAFFE OMNIBED CARESTATION CS1, GIRAFFE OMNIBED CARESTATION, OMNIBED SW EBASE S-HUMID, Giraffe OmniBed Legacy, OMNIBED FR EBASE S-HUMID, OMNIBED GR EBASE S-HUMID, OMNIBED SP EBASE S-HUMID, ASSY-LAU, OMNIBED ENG EBASE S-HUMI D, Finished good - Make, OBSOLETE-OMNIBED UK EBASE S-HUMID, OMNIBED UK EBASE S-HUMID. Incubator, Neonatal
FDA Recall
Open, Classified
·DATEX--OHMEDA, INC.·Product code FMZ·May 19, 2023
KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
FDA 510(k)
FDA Class 2
·Cardiovascular
CastleLoc Pectus Bar System Instrument Set
FDA UDI
L&K BIOMED CO. ,LTD.·08809986460295·EZ Crane System 1
Trulink
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522125942·NIBP,HOSE,NEO.,QUICK RELEASE
Compumedics Quik-Cap
FDA UDI
COMPUMEDICS LIMITED·09342451004673·Quik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch...
ENDOSKELETON® DPK
FDA UDI
TITAN SPINE, LLC·00191375052357·Lid (cover)
WVSM Wireless Vital Signs Monitor
FDA UDI
ATHENA GTX, INC.·B3944670019010·WVSM Power Cord (US)
QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 17, 2024
SUMMIT POR TAPER SZ6 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDIC INC, 1818910·Product code LPH·June 21, 2018
MINICAP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 13, 2015
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·August 12, 2014