| FADASSI MEDICAL FM-1 NO BLENDER (K003665) | Fadasis Medical, Inc. | 2001-02-23 |
| PERCUSSIVENEB, MODEL PN-2001 (K003684) | Vortran Medical Technology 1, Inc. | 2001-02-23 |
| CORTEX METAMAX (K001631) | Cortex Biophysik GmbH | 2001-02-22 |
| TE ME NA EPIDURAL CATHETER (K991259) | Te ME NA S.A.R.L. | 2001-02-21 |
| MODULAR (K001988) | Heyer America, Inc. | 2001-02-05 |
| OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) (K003704) | Optovent AB | 2001-02-05 |
| ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (K002201) | Sims Portex, Inc. | 2001-02-05 |
| TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR (K003982) | Magnetic Resonance Equipment Corp. | 2001-01-26 |
| NARKOMED MRI-2, MODEL NM-MRI-2 (K003579) | Draeger Medical, Inc. | 2001-01-22 |
| PC FLOW + (K001528) | Spirometrics Medical Equipment Co. | 2001-01-18 |
| COSMED QUARK (K001174) | Cosmed Srl | 2001-01-11 |
| MICROSTREAM EXTERNAL BATTERY CHARGER (K002163) | Oridion Medical 1987 , Ltd. | 2001-01-11 |
| APNOESCREEN PRO, ALPHA SCREEN PRO (K000396) | Erich Jaeger, Inc. | 2000-12-27 |
| CAPNO PROBE A (K984579) | Optical Sensors, Inc. | 2000-12-21 |
| BIRD TBIRD LEGACY VENTILATOR (K003770) | Bird Products Corp. | 2000-12-15 |
| M-XX OXYGEN SENSORS (K002384) | International Business Strategies | 2000-12-15 |
| METALYZER, MODEL 2; METALYZER, MODEL 3 (K993641) | Cortex Biophysik GmbH | 2000-12-14 |
| BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (K002506) | Sims Portex, Inc. | 2000-12-14 |
| MAGELLAN VENTILATOR (K002951) | Oceanic Medical Products, Inc. | 2000-12-08 |
| TCM400 (K001866) | Radiometer Medical A/S | 2000-12-07 |
| SLEEPSTRIP DISPOSABLE APNEA SCREENER (K002135) | Influent , Ltd. | 2000-12-06 |
| MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS (K002795) | Hypertec, Inc. | 2000-12-06 |
| MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401 (K003455) | Chad Therapeutics, Inc. | 2000-12-06 |
| MODEL 5000 MULTIPLACE HYPERBARIC THERAPY (K002794) | Hypertec, Inc. | 2000-12-06 |
| ACAPELLA (K002768) | Dhd Healthcare Corp. | 2000-12-05 |
| DISPOSABLE PRESSURE MONITOR (K003497) | Engineered Medical Systems | 2000-11-30 |
| SENSAIRE DIAGNOSTIC SPIROMETER (K001278) | Qrs Diagnostic, LLC | 2000-11-29 |
| ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER (K002288) | Cook, Inc. | 2000-11-28 |
| EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING (K002598) | J. H. Emerson Co. | 2000-11-22 |
| CLINIFLO INCENTIVE SPIROMETER (K003146) | Dhd Healthcare Corp. | 2000-11-21 |
| SILENT NIGHT V (K000253) | Sleep Solutions, Inc. | 2000-11-16 |
| VBMAX (K000654) | A-M Systems, Inc. | 2000-11-14 |
| NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K002677) | Nuvasive, Inc. | 2000-11-13 |
| BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE (K002499) | Brentwood Medical Technology Corp. | 2000-11-08 |
| SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (K003315) | Mallinckrodt, Inc. | 2000-11-08 |
| MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (K001714) | Mercury Medical | 2000-11-03 |
| CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60 (K001213) | Hudson Respiratory Care, Inc. | 2000-11-03 |
| LITEAIRE (K993101) | Thayer Medical Corp. | 2000-10-26 |
| HEATED HUMIDIFIER (K983783) | Pegasus Research Corp. | 2000-10-24 |
| PDT DOSECALCULATOR, MODEL 80000 (K000418) | Retinalabs.Com | 2000-10-24 |
| VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX (K002284) | Invacare Corp. | 2000-10-24 |
| AERO-CLICK (K993094) | Map Medizintechnik Fur Arzt Und Patient GmbH | 2000-10-23 |
| PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION (K001646) | Puritan Bennett Corp. | 2000-10-20 |
| ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+E (K002686) | Nellcor Puritan Bennett, Inc. | 2000-10-18 |
| CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 (K994059) | Hdc Corp. | 2000-10-13 |
| AERONEB PORTABLE NEBULIZER (K003022) | Aerogen, Inc. | 2000-10-13 |
| VENTILATOR, CONTINUOUS (RESPIRATOR), MODEL LTV 1000 (K002881) | Pulmonetic Systems, Inc. | 2000-10-11 |
| NARKOMAT, MODEL 2000 (K000995) | Heyer America, Inc. | 2000-10-11 |
| RESUSCI INFLATE-A-SHIELD CPR BARRIER (K001742) | Laerdal Medical Corp. | 2000-10-06 |
| SPIROL EPIDURAL CATHETER (K000886) | Abbott Laboratories | 2000-10-05 |
| DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER (K002878) | Datex-Ohmeda, Inc. | 2000-09-21 |
| MICOR CONDUCTION CATHETER (K001717) | Micor, Inc. | 2000-09-20 |
| IPI HUMIDIFIER CHAMBER (K993282) | I.P.I. Medical Products | 2000-09-18 |
| LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC) (K002255) | Wolfe Tory Medical, Inc. | 2000-09-18 |
| HUMID-HEAT (K993773) | Hudson Rcj AB | 2000-09-13 |
| RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 (K000705) | Respironics, Inc. | 2000-09-08 |
| VITALOGRAPH BASE STATION (K000599) | Vitalograph, Inc. | 2000-09-08 |
| SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 (K002465) | Respironics, Inc. | 2000-09-08 |
| BREEZE SLEEPGEAR WITH DREAMSEAL (K002001) | Puritan Bennett Corp. | 2000-09-06 |
| IMPULSE SELECT (K001579) | Airsep Corp. | 2000-08-31 |
| SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR (K000700) | Sensidyne, Inc. | 2000-08-31 |
| ULTIMA SMARTBELT, MODEL 0560 (K001743) | Braebon Medical Corp. | 2000-08-25 |
| AERONEB II, MODEL APN 200 (K992831) | Aerogen, Inc. | 2000-08-25 |
| VAPOTHERM, MODEL 2000I (K000401) | Vapotherm, Inc. | 2000-08-24 |
| DATEX-OHMEDA COMPACT AIRWAY MODULE M-CAIOVX AND M-COVX (VERSION 01) AND ACCESSORIES (K001814) | Datex-Ohmeda | 2000-08-23 |
| OFFICE BASED ANESTHESIA MACHINE, MODEL OBA-1 (K000859) | Charles A. Smith | 2000-08-23 |
| SANSIBAR CPAP SYSTEM (K000888) | Prym Medical , Ltd. | 2000-08-15 |
| MICOR ANESTHESIA CONDUCTION KIT (K001940) | Micor, Inc. | 2000-08-11 |
| MALLARD AIR OXYGEN ACCUBLENDER (K001609) | Mallard Medical, Inc. | 2000-08-10 |
| MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES (K001727) | Blease Medical Equipment , Ltd. | 2000-08-09 |
| AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 (K000653) | Pulmonox Medical Corp. | 2000-08-04 |
| NEWPORT HT50 VENTILATOR WITH HUMIDIFIER HT50-H, NEWPORT HT50 VENTILATOR WITHOUT HUMIDIFIER, HT50-H1, NEWPORT HT50 VENTIL (K992133) | Newport Medical Instruments, Inc. | 2000-08-04 |
| BREAS PV 100 CPAP SYSTEM (K001553) | Vital Signs, Inc. | 2000-08-03 |
| GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER (K001409) | Hyperbaric Technologies, Inc. | 2000-08-02 |
| CPAP SYSTEM, MODEL 102001 (K001318) | Sims Portex, Inc. | 2000-07-20 |
| 19 GA PLASTIC REINFORCED EPIDURAL CATHETER (K001587) | Arrow Intl., Inc. | 2000-07-12 |
| AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (K001502) | Erich Jaeger GmbH | 2000-07-12 |
| PROLONG, MODELS PL50, PL100, PL150 (K001129) | Life-Tech Intl., Inc. | 2000-07-06 |
| RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000 (K001430) | Vortran Medical Technology 1, Inc. | 2000-07-05 |
| AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) (K001137) | Trudell Medical Int'L | 2000-07-05 |
| MALLINCKRODT, GOODKNIGHT 418S (K001845) | Mallinckrodt Developpement France | 2000-07-05 |
| OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130 (K001095) | Teledyne Analytical Instruments | 2000-06-30 |
| GALILEO VENTILATOR (K001686) | Hamilton Medical, Inc. | 2000-06-23 |
| CRITERION 60 OR PM 60 (K000959) | Caradyne, Ltd. | 2000-06-22 |
| BIPAP DUET LX BI-LEVEL SYSTEM (K000994) | Respironics, Inc. | 2000-06-22 |
| OCD2001 (K992935) | Contemporary Products, Inc. | 2000-06-20 |
| CHAD THERAPEUTICS OXYMATIC MODEL 401 (K000890) | Chad Therapeutics, Inc. | 2000-06-16 |
| CONTEMPRO-MIST (K000543) | Contemporary Products, Inc. | 2000-06-16 |
| NARKOMED MRI , NM-MRI (K001488) | Draeger Medical, Inc. | 2000-06-09 |
| TRI-BALL (K994074) | Leventon, S.A. | 2000-06-08 |
| BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 (K990435) | Apex Medical Corp. | 2000-06-05 |
| PHOENIX EPIDURAL & SPINAL NEEDLES (K990519) | Myco Medical Supplies, Inc. | 2000-06-02 |
| RUSCH EMERGENCY MASK (K993528) | Rusch, Inc. | 2000-05-31 |
| BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER (K993010) | Environmental Tectonics Corp. | 2000-05-30 |
| MODIFICATION TO KION ANESTHESIA SYSTEM (K001315) | Siemens Elema AB | 2000-05-26 |
| SWIVEL ELBOW (K000215) | Engineered Medical Systems | 2000-05-26 |
| HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 780-43 (K993355) | Hudson Respiratory Care, Inc. | 2000-05-24 |
| HME-BOOSTER (K990614) | King Systems Corp. | 2000-05-23 |
| NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 (K993921) | Ndd Medical Technologies | 2000-05-23 |
| MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (K994188) | Agilent Technologies, GmbH | 2000-05-19 |