SMARTbuilder System (SB1)

FDA UDI

Osstem Implant Co., Ltd.·08800000925196·

SMARTbuilder System (SB1)

FDA UDI

Osstem Implant Co., Ltd.·08800000925226·

Status DS™ 8 card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000433·Status DS™ T/O/C/A//BZ/BA/TC/P card; 25 Test kit

Status DS™ 8 card

FDA UDI

PRINCETON BIOMEDITECH CORPORATION·10743816000440·Status DS™ T/O/C/A//BZ/BA/TC/P card; 10 Test kit

Speedboat Flush SB1 Instrument

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

AAIO-7, AAIO WIRLESS

FDA 510(k)

FDA Class 2 ·Ophthalmic

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)

FDA UDI

ALERE SAN DIEGO, INC.·00810124273286·

STATDIP®

FDA UDI

MICRO DISTRIBUTING, L.C·00816036020062·STAT DOA Single Test CLIA Waived Dipcard, 25Pcs...

iScreen™

FDA UDI

Instant Technologies, Inc.·00817405022281·iScreen BZO Panel(Urine) 25T

DTX®

FDA UDI

ONE STEP DETEX ASSOCIATES·10858917006014·

NA

FDA UDI

ALERE SAN DIEGO, INC.·10815845020178·

NA

FDA UDI

ALERE SAN DIEGO, INC.·10815845020185·

iCassette™

FDA UDI

Instant Technologies, Inc.·00817405022564·iCassette BZO Dev(Urine) 25T

Gas-machine, anesthesia

FDA registration

ACCUTRON, INC.·1 product·🇺🇸 United States

Avance CS2 Carestation

FDA registration

Datex-Ohmeda, Inc.·1 product·🇺🇸 United States

Aestiva/5 MRI

FDA registration

Datex-Ohmeda, Inc.·1 product·🇺🇸 United States

BleaseGenius

FDA registration

SPACELABS HEALTHCARE LTD.·1 product·🇬🇧 United Kingdom

CompuRecord System

FDA registration

Philips Electronics Ltd·1 product·🇨🇦 Canada