Remote Diagnostic Technologies , Ltd.
Remote Diagnostic Technologies , Ltd. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2018, with 12 FDA device recalls on record.
Top product codes for Remote Diagnostic Technologies , Ltd.
FDA recalls by Remote Diagnostic Technologies , Ltd.
10 most recent of 12- Z-1027-2026 — Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
- Z-2175-2025 — Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
- Z-1666-2025 — Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
- Z-1729-2025 — Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
- Z-0557-2025 — Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
- Z-2028-2024 — Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Z-2625-2023 — Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
- Z-1825-2023 — Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Z-1321-2023 — Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
- Z-0861-2022 — Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Remote Diagnostic Technologies , Ltd.
- K173768 — Tempus Pro Patient Monitor
- K170567 — Tempus Pro Patient Monitor
- K133973 — TEMPUS PRO WITH ENHANCED FEATURES
- K134014 — TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
- K133988 — TEMPUS PRO EXTENDED FEATURES
- K130773 — TEMPUS PRO PATIENT MONITOR
- K113105 — TEMPUSIC PATIENT MONITOR
- K101264 — TEMPUS IC PROFESSIONAL PATIENT MONITOR
- K082718 — TEMPUSIC PATIENT MONITOR
- K033410 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
- K010436 — TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
Data sourced from openFDA. This site is unofficial and independent of the FDA.