Panels › General Hospital › Product code FLN · Class 2
Monitor, Electric For Gravity Flow Infusion Systems
Regulation 880.2420
0510(k)s in 12 months (39 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FLN
| Company | 510(k)s | Recalls |
|---|---|---|
| Imed Corp. | 4 | 0 |
| Shift Labs | 2 | 0 |
| Travenol Laboratories, S.A. | 2 | 0 |
| A.R. Nelson Co., Inc. | 1 | 0 |
| Aci Medical, Inc. | 1 | 0 |
| Alexander Mfg. Co. | 1 | 0 |
| American Mcgaw | 1 | 0 |
| Baxter Healthcare Corp | 1 | 0 |
| Centaur Sciences, Inc. | 1 | 0 |
| Coleman Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2018 | K172242 | DripAssist Plus Shift Labs, Inc. | FLN |
| Oct 13, 2015 | K150687 | DripAssist Shift Labs | FLN |
| Apr 24, 2014 | K133870 | FLUID LEVEL MONITOR Coleman Laboratories | FLN |
| Apr 17, 2008 | K080704 | LOW FLUID ALARM Em-Tec GmbH, DE | FLN |
| Feb 22, 2006 | K050783 | ISSYS DRUG FLOW MONITOR Integrated Sensing Systems, Inc. | FLN |
| Feb 14, 2006 | K060123 | LEVELERT II FLUID LEVEL SENSOR Smith & Nephew, Inc. | FLN |
| Apr 7, 2003 | K030136 | DRIP ALERT Drip Alert, Inc. | FLN |
| Aug 6, 2002 | K022248 | STRYKER L3 HYDROLERT Stryker Endoscopy | FLN |
| Oct 15, 2001 | K013121 | MT ALERT INFUSION MONITOR Sierra Biosearch, Inc. | FLN |
| Nov 20, 1997 | K973025 | FLUID CENTURION (4-100-00) Northgate Technologies, Inc. | FLN |
| Jul 3, 1997 | K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 Alexander Mfg. Co. | FLN |
| May 26, 1993 | K923561 | AC-901 I.V. INFUSION DROP COUNTER Lamtic, Inc. | FLN |
| Oct 3, 1991 | K910323 | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) Uab Research Foundation | FLN |
| Oct 1, 1990 | K902808 | DRIPTROL Trans-Pacific Healthcare-USA | FLN |
| Aug 30, 1990 | K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM Smith & Nephew Dyonics, Inc. | FLN |
| Oct 27, 1989 | K893693 | H.U. I.V. DROP COUNTER Li-Lien Corp. | FLN |
| Jan 9, 1986 | K853843 | IV MATE Medtech Intl., Inc. | FLN |
| Nov 12, 1985 | K853549 | MCGAW/DROP WATCH FLOW MONITOR American Mcgaw | FLN |
| Jun 27, 1985 | K852433 | INFUSAFE 205 CATOLOG NO. 205.000 Medix Medical Electronics (U.S.A.), Inc. | FLN |
| Apr 4, 1985 | K850710 | TRAVENOL FLO-GARD 500 IV MONITOR Travenol Laboratories, S.A. | FLN |
| Jan 22, 1985 | K844309 | IV RATEMETER Aci Medical, Inc. | FLN |
| Jan 22, 1985 | K844227 | INFUSART Sartorius, Inc., DE | FLN |
| Jan 14, 1985 | K844556 | KHM 2000 DRIP WATCHER The Timeter Group | FLN |
| Jul 12, 1983 | K831596 | DROP RATE COUNTER #340 Imed Corp. | FLN |
| Jan 26, 1983 | K823018 | MODEL 460 INTERMITTENT MEDICATION DELIV Y | FLN |
| Aug 16, 1982 | K821823 | I.V. SENTINEL The John Bunn Co. | FLN |
| Nov 12, 1980 | K802166 | MODEL AS* 7B AUTOSYRINGE INFUSION PUMP Baxter Healthcare Corp | FLN |
| Oct 31, 1980 | K802011 | INFUSSION ALARM SYSTEM I.A.S. CAT.#1118 Pollak (Intl.), Ltd. | FLN |
| Oct 23, 1980 | K801734 | IMED DROP RATE CALCULATOR #340 Imed Corp. | FLN |
| Sep 16, 1980 | K802101 | I.V. SENTRY ALARM DEVICE Pike Medical Co. | FLN |
| Jul 30, 1979 | K790836 | GUARDIAN II I.V. CONTROLLER Centaur Sciences, Inc. | FLN |
| May 14, 1979 | K790669 | DROP CONTROLLER Imed Corp. | FLN |
| Nov 22, 1978 | K781589 | VOLUMETRIC CONTROLLER MODEL 310 Imed Corp. | FLN |
| Oct 27, 1978 | K781717 | MONITOR, GRAVITY IRRIGATION DRIP Syntel, Inc. | FLN |
| Oct 25, 1978 | K781297 | INTRA-ALERT Pan-Tech Research, Inc. | FLN |
| Apr 10, 1978 | K780223 | PARENTERAL INFUSION CONTROLLER Travenol Laboratories, S.A. | FLN |
| Feb 21, 1978 | K780106 | PARENTERAL INFUSION CONTROLLER, ELEC. National Patent Development Corp. | FLN |
| Jan 5, 1977 | K760931 | I.V. DRIP MONITOR ALARM DEVICE, MONIFLO Diemolding Corp. | FLN |
| Dec 23, 1976 | K760694 | ARNCO I.V. MONITOR A.R. Nelson Co., Inc. | FLN |
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