| MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET (K013916) | Cook, Inc. | 2001-12-20 |
| SPIRIT 300 (K013251) | Caire, Inc. | 2001-12-18 |
| HOME-AWAY SYSTEM (K004047) | In-X Corp. | 2001-12-18 |
| SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407E (K010925) | Siemens Elema AB | 2001-12-18 |
| RENMED CONTAMI-SHIELD BREATHING CIRCUIT SLEEVE, MODEL 9999/01 (K013200) | Rennels Medical Corp. | 2001-12-14 |
| KNIGHTSTAR 330 VENTILATOR (K003075) | Mallinckrodt, Inc. | 2001-12-11 |
| MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 (K013027) | Respironics Healthscan, Inc. | 2001-12-06 |
| AVID-NIT PLASTIC HUB LUTZ EPIDURAL NEEDLE,MODEL RP2035L, AVID-NIT METAL HUB LUTZ EPIDURAL NEEDLE, MODEL RM2035L (K013231) | Avid N.I.T., Inc. | 2001-12-03 |
| KP + LFM (K013489) | Pds Healthcare Products, Inc. | 2001-11-29 |
| MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE (K013845) | Oridion Medical 1987 , Ltd. | 2001-11-29 |
| MULTISTIM (K011308) | Pajunk GmbH | 2001-11-29 |
| OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) (K001121) | Engineered Medical Technology, Inc. | 2001-11-29 |
| TOTAL O2 (K013472) | Chad Therapeutics, Inc. | 2001-11-28 |
| RUSCH BRONCHUS BLOCKER KIT (K010596) | Rusch Intl. | 2001-11-21 |
| BALLPEN SPINAL NEEDLE W/WO INTRODUCER (K011122) | Rusch Intl. | 2001-11-16 |
| MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE (K011536) | Oridion Medical 1987 , Ltd. | 2001-11-14 |
| WATCH-PAT 100 (K010739) | Itamar Medical (C.M.) 1997 , Ltd. | 2001-11-06 |
| BERNOULLI VENTILATOR MANAGEMENT SYSTEM (K011861) | Cardiopulmonary Corp. | 2001-11-06 |
| MINIME NASAL MASK, MODEL P/N 50220 (K013306) | Sleepnet Corporation | 2001-11-02 |
| MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM (K013215) | Nuvasive, Inc. | 2001-10-16 |
| MAGELLAN-2200, MODEL 1 (K010613) | Oceanic Medical Products, Inc. | 2001-10-12 |
| SDI SB OFFICE, MODEL 29- (K011470) | Sdi Diagnostics, Inc. | 2001-10-12 |
| MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016) | Cook, Inc. | 2001-10-09 |
| ABI VEST AIRWAY CLEARANCE SYSTEM (K012928) | Advanced Respiratory | 2001-10-09 |
| MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE (K012485) | King Systems Corp. | 2001-10-09 |
| END EXPIRATORY FILTER, MODEL RT020 (K002839) | Fisher & Paykel Healthcare, Ltd. | 2001-10-04 |
| OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI (K012446) | Charles A. Smith | 2001-10-03 |
| TE ME NA POLYSTIM NERVE STIMILATOR (K990323) | Te ME NA S.A.R.L. | 2001-09-28 |
| AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER (K012939) | Monaghan Medical Corp. | 2001-09-28 |
| V*CARE MANUAL RESUSCITATOR (K012842) | Ventlab Corp. | 2001-09-18 |
| MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT (K012584) | Bd | 2001-09-06 |
| VENTVIEW, MODEL 8414095 (K012177) | Drager Medizintechnik GmbH | 2001-09-04 |
| MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS (K011844) | Merits Health Products., Inc. | 2001-08-28 |
| INFANT OXYGEN TREATMENT HOOD (K011565) | Gulf Coast Hyperbarics, Inc. | 2001-08-16 |
| MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE (K012395) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| MAC-LINE CO2 NASAL CANNULA SAMPLE LINE (K012391) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE (K012394) | Oridion Medical 1987 , Ltd. | 2001-08-15 |
| THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY (K011210) | Rusch Intl. | 2001-08-15 |
| TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE (K011571) | The RX Files Corp. | 2001-08-09 |
| MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT (K012034) | Sensor Medics Corp. | 2001-07-24 |
| AV 800 VENTILATOR (K010317) | Penlon , Ltd. | 2001-07-23 |
| ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 (K012207) | Tiara Medical Systems, Inc. | 2001-07-23 |
| FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW (K012178) | Fresenius Hemotechnology, Inc. | 2001-07-23 |
| PRIMA OXYGEN MONITOR (K010318) | Penlon , Ltd. | 2001-07-23 |
| FADASIS MEDICAL FM-1 NO BLENDER (K011874) | Fadasis Medical, Inc. | 2001-07-20 |
| IVENT 201 PORTABLE VENTILATOR (K011957) | Versamed , Ltd. | 2001-07-18 |
| BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM (K011312) | Khrunichev State Research & Production Space Centr | 2001-07-18 |
| MEDICAL DEPOT POWER NEB 1 (K012006) | Medical Depot, Inc. | 2001-07-13 |
| DEVILBISS 9000 SERIES CPAP, MODEL 9001 (K011229) | Sunrise Medical Hhg, Inc. | 2001-07-11 |
| SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE (K003663) | Spacelabs Medical, Inc. | 2001-06-28 |
| BIPAP PRO BI-LEVEL SYSTEM (K011714) | Respironics, Inc. | 2001-06-28 |
| Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (K003927) | Cheen Houng Ent. Co. , Ltd. | 2001-06-26 |
| MANAN SPRITACRE SPINAL NEEDLES (K011209) | Manan Medical Products, Inc. | 2001-06-26 |
| ORACLE ORAL MASK (K003894) | Fisher & Paykel Healthcare, Ltd. | 2001-06-25 |
| SAVINA (K003068) | Drager Medizintechnik GmbH | 2001-06-25 |
| COMOACT ULTRASONIC NEBULIZER, MODEL 3060 (K002543) | San UP S.A. | 2001-06-14 |
| NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 (K010093) | Drager Medizintechnik GmbH | 2001-06-14 |
| NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI (K011125) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| OXYGEN SUPPLY TUBING, MODEL 1115 (K011134) | Hudson Respiratory Care, Inc. | 2001-06-13 |
| INFANT FLOW SYSTEM, MODEL M672P (K011516) | Eme (Electro Medical Equipment) , Ltd. | 2001-06-08 |
| AIRLIFE HEPA FILTER (K011132) | Allegiance Healthcare Corp. | 2001-06-08 |
| SIGMA DELTA (K002343) | Penlon , Ltd. | 2001-06-08 |
| STIMUPLEX HNS-11 (K003983) | Stockert GmbH | 2001-06-06 |
| HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR (K002846) | Headstar Medical Products Co., Ltd. | 2001-06-06 |
| INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM (K003472) | Sequal Technologies, Inc. | 2001-06-04 |
| SPINAL EPIDURAL NEEDLES (K002405) | Te ME NA S.A.R.L. | 2001-06-01 |
| RESPIRATORY HUMIDIFIER, MODEL HC150 (K003973) | Fisher & Paykel Healthcare, Ltd. | 2001-06-01 |
| KOKO PEAK KP; KOKO PEAK KP+ (K010009) | Pds Healthcare Products, Inc. | 2001-06-01 |
| CT SPACER (K010680) | Clinical Technologies, Inc. | 2001-05-23 |
| VEGA ULTRASONIC NEBULIZER (K002831) | Vega Technologies, Inc. | 2001-05-23 |
| BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690 (K003251) | Blease Medical Equipment , Ltd. | 2001-05-23 |
| OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830 (K010747) | Western Ent. | 2001-05-16 |
| SEA-LONG MEDICAL TREATMENT HOOD (K010659) | Sea-Long Medical Systems, Inc. | 2001-05-16 |
| DEVILBISS HUMIDIFIER (K003626) | Sunrise Medical Hhg, Inc. | 2001-05-04 |
| MICROGAS 7650 TRANSCUTANEOUS MONITOR (K003943) | Linde Medical Sensors AG | 2001-05-04 |
| REMREST (K002763) | Medical Industries America, Inc. | 2001-05-04 |
| MICROSTREAM ORAL NASAL CANNULA FILTERLINE (K011050) | Oridion Medical 1987 , Ltd. | 2001-05-04 |
| TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 (K010578) | Taga Medical Technologies, Inc. | 2001-04-25 |
| DORNIR LC-1 CPAP SYSTEM (K010704) | Prym Medical , Ltd. | 2001-04-18 |
| INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 (K003561) | Invacare Corp. | 2001-04-17 |
| CAPNOPROBE SL, MODEL 2000 (K010795) | Optical Sensors, Inc. | 2001-04-11 |
| PNS MAGNETIC STIMULATOR SYSTEM (K002889) | Neotonus, Inc. | 2001-04-06 |
| REMSTAR PLUS CPAP SYSTEM (K010263) | Respironics, Inc. | 2001-03-29 |
| CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411 (K010389) | Chad Therapeutics, Inc. | 2001-03-23 |
| VENTURE HOME FILL II, MODEL IOH 200 (K003939) | Invacare Corp. | 2001-03-21 |
| MODIFICATION TO LAP TOP VENTILATOR (LTV) (K010608) | Pulmonetic Systems, Inc. | 2001-03-20 |
| PM 1800 CONSERVING DEVICE (K001412) | Precision Medical, Inc. | 2001-03-20 |
| MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 (K003344) | Medical Depot, Inc. | 2001-03-15 |
| Y2000 POCKET RESCUE (K010191) | Cheen Houng Ent. Co. , Ltd. | 2001-03-14 |
| SMOOTH-FLO CIRCUIT (K010402) | Hudson Respiratory Care, Inc. | 2001-03-14 |
| 'ALL 2000' % OXYGEN ANALYZER (K002382) | Analytical Industries, Inc. | 2001-03-14 |
| O2/CO2 NASAL FILTERLINE (K010024) | Oridion Medical 1987 , Ltd. | 2001-03-14 |
| PRONEB ULTRA MODEL NUMBER 85B0100 (K002862) | Pari Holding Co. | 2001-03-13 |
| ULTRASONIC NEBULIZER, MODEL NE-520 (K002153) | Medisana USA, Inc. | 2001-03-13 |
| SLEEVED FILTER (K010040) | King Systems Corp. | 2001-03-09 |
| INFINITY ETCO2 + RESPIRATORY MECHANICS POD (K003550) | Siemens Medical Solutions USA, Inc. | 2001-03-07 |
| BREAS HA50 HUMIDIFIER, MODEL HA50 (K002454) | Vital Signs, Inc. | 2001-03-07 |
| SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 (K002468) | San UP S.A. | 2001-03-02 |
| SNAP MODEL 6 (K002095) | Snap Laboratories, LLC | 2001-03-02 |
| 100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I (K010382) | Sensidyne, Inc. | 2001-03-01 |