| AMBU NEONATE SILICONE RESUSCITATOR (K993278) | Ambu, Inc. | 2000-05-17 |
| AXIOM MULTIPURPOSE WOUND DRAIN (K993592) | Axiom Medical, Inc. | 2000-05-17 |
| C-IT (K000520) | Bregas AB | 2000-05-16 |
| SPIROVIT SP-2, PNEUMOCHECK II (K992823) | Schiller AG | 2000-05-12 |
| AIRPILOTMASK, MODEL TMS-900 (K992192) | Tiara Medical Systems, Inc. | 2000-05-12 |
| ESPIRT (K001208) | Respironics, Inc. | 2000-05-12 |
| RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S (K001030) | Dymedix, Inc. | 2000-05-11 |
| DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR (K000706) | Datex-Ohmeda, Inc. | 2000-05-11 |
| CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (K993619) | Sims Portex, Inc. | 2000-04-28 |
| PORTABLE INTENSIVE CARE UNIT, MODEL PIC (K000712) | Medical Research Laboratories, Inc. | 2000-04-27 |
| STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (K000964) | Automatic Liquid Packaging, Inc. | 2000-04-25 |
| DATES-OHMEDA AESTIVA SMARTVENT MRI (K993410) | Datex-Ohmeda, Inc. | 2000-04-25 |
| DEVILBISS NEBULIZER MODEL 800 (K993492) | Sunrise Medical Hhg, Inc. | 2000-04-21 |
| PICO SMOKERLYZER, MODEL EC-50 (K000962) | Bedfont Scientific, Ltd. | 2000-04-20 |
| MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT (K993268) | Mallinckrodt Dar S.R.L. | 2000-04-19 |
| RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE (K000406) | Rhino Metrics A/S | 2000-04-17 |
| INCENTIVE SPIROMETER (K000314) | Engineered Medical Systems | 2000-04-12 |
| DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA (K000275) | Datex-Ohmeda, Inc. | 2000-04-12 |
| UNIPOLAR NEEDLES (K000722) | Pajunk GmbH | 2000-03-31 |
| MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS (K000697) | Allegiance Healthcare Corp. | 2000-03-30 |
| SPIRO PRO (K000648) | Erich Jaeger GmbH | 2000-03-29 |
| BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLES (K000495) | Ballard Medical Products | 2000-03-28 |
| POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER (K993199) | Ferraris Medical, Inc. | 2000-03-28 |
| RUSCH MANUAL RESUSCITATOR BAG (K993194) | Rusch, Inc. | 2000-03-24 |
| SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 (K994352) | Hudson Respiratory Care, Inc. | 2000-03-22 |
| BIPAP SYNCHRONY HC (K992530) | Respironics, Inc. | 2000-03-20 |
| POSITUBE (K000045) | Paraproducts, Inc. | 2000-03-15 |
| DATEX-OHMEDA TONOMETRY MODULE M-TONO (K993656) | Datex-Ohmeda, Inc. | 2000-03-15 |
| NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER (K990897) | Puritan-Bennett Ireland, Ltd. | 2000-03-15 |
| MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 (K993584) | Nellcor Puritan Bennett France Dvpt. | 2000-03-07 |
| QUICKAIR CHOKE RELIEVER, MODEL 59-001A (DEN000004) | Maet Industries, Inc. | 2000-02-29 |
| ONEFLOW (K980951) | Sti Medical | 2000-02-25 |
| OXYCON PRO (K992214) | Erich Jaeger B.V. | 2000-02-22 |
| DATEX-OHMEDA INOVENT DELIVERY SYSTEM (K000186) | Datex-Ohmeda | 2000-02-10 |
| VITALOGRAPH MICRO (K991412) | Vitalograph, Inc. | 2000-02-04 |
| ILM ENDOTRACHEAL TUBE (K991580) | The Laryngeal Mask Co., Ltd. | 2000-02-04 |
| TED 200T7 OXYGEN MONITOR (K990403) | Teledyne Electronic Technologies | 2000-02-03 |
| SNAP MODEL 5 (K992322) | Snap Laboratories, LLC | 2000-02-02 |
| RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY (K993786) | Rusch Intl. | 2000-02-02 |
| METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (K991355) | Instrumentation Industries, Inc. | 2000-01-27 |
| ABI VEST AIRWAY CLEARANCE SYSTEM (K993629) | American Biosystems, Inc. | 2000-01-21 |
| MODIFICATION TO LASER-SHIELD II (K993582) | Xomed, Inc. | 2000-01-20 |
| 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR, BAG RESERVOIR, 1ST RE (K991861) | Sims Portex, Inc. | 2000-01-18 |
| HANNAH WIRELESS VITAL SIGNS MONITOR (K991087) | Ilife Systems, Inc. | 2000-01-12 |
| SIEMEMNS INFINITY ETC02 POD (K992116) | Siemens Medical Solutions USA, Inc. | 2000-01-12 |
| FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01 (K992256) | Intercontinental New Technologies, Inc. | 2000-01-11 |
| HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 (K990856) | Bird Products Corp. | 2000-01-11 |
| OHMEDA INOVENT DELIVERY SYSTEM (DEN000001) | Ohmeda Medical | 2000-01-11 |
| FLOSENSE, MODEL 29-8010 (K990962) | Sdi Diagnostics, Inc. | 2000-01-07 |
| SALTER AIRE COMPRESSOR (K992285) | Salter Labs | 2000-01-07 |
| CRITERION 40 OR PM 40 (K992101) | Caradyne, Ltd. | 2000-01-06 |
| BIRD V.I.P. GOLD/STERLING (K993449) | Bird Products Corp. | 1999-12-20 |
| AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS (K993833) | Allegiance Healthcare Corp. | 1999-12-10 |
| CPAP/PRO CPAP INTERFACE (K992384) | Stevenson Industries, Inc. | 1999-12-01 |
| NASAL AIRE (K990659) | Breathing Technologies Corp. | 1999-11-26 |
| PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 (K993071) | Puritan Bennett Corp. | 1999-11-24 |
| TRENDCARE CALIBRATOR MODEL SCU 7007 (K983198) | Diametrics Medical, Ltd. | 1999-11-23 |
| NELLCOR PURITAN BENNETT ACHIEVA VENTILATOR AND REPORT GENERATOR (K990177) | Nellcor Puritan Bennett, Inc. | 1999-11-18 |
| HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOLITE 2 FAMILY OF AUTOLOGOUS BLOOD RECOVER (K993581) | Haemonetics Corp. | 1999-11-18 |
| SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER (K990927) | Perry Baromedical Corp. | 1999-11-12 |
| EZFLOW MAX, MODEL 1007 (K993558) | Piper Medical Products | 1999-11-12 |
| ROADRUNNER, PEP THERAPY DEVICE (K991561) | Dhd Healthcare Corp. | 1999-11-10 |
| RESPIRONICS TOTAL FACE MASK (K992969) | Respironics, Inc. | 1999-11-10 |
| PRIMEAIRE (K992722) | Thayer Medical Corp. | 1999-11-10 |
| MILLENNIUM INFANT VENTILATOR (K993167) | Sechrist Industries, Inc. | 1999-11-10 |
| TED 60T OXYGEN ANALYZER (K990457) | Teledyne Electronic Technologies | 1999-11-09 |
| FACE-2-FACE CPR PROTECTION SHIELD (K991617) | Whiteline Plastics, Inc. | 1999-11-03 |
| DEVILBISS 5 LITER OXYGEN CONCENTRATOR (K991722) | Sunrise Medical Hhg, Inc. | 1999-11-03 |
| SIEMENS FIO2 SENSOR (K991884) | Siemens Medical Solutions USA, Inc. | 1999-11-03 |
| RESPALERT (K992618) | Harwill Medical (Pty) , Ltd. | 1999-10-29 |
| SPRING-WOUND EPIDURAL CATHETER (K991879) | Micor, Inc. | 1999-10-28 |
| MODEL IRC 1001 AEROSOL COMPRESSOR (K992643) | Invacare Corp. | 1999-10-27 |
| VIRTUOSO LX SMART CPAP SYSTEM (K993433) | Respironics, Inc. | 1999-10-27 |
| CRICOTHYROTOMY TUBE (K983000) | Polamedco, Inc. | 1999-10-27 |
| GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (K992421) | Accutron, Inc. | 1999-10-27 |
| IQ NASAL MASK, MODEL P/N 50160 (K993269) | Sleepnet Corporation | 1999-10-27 |
| ARIA LX CPAP SYSTEM (K993307) | Respironics, Inc. | 1999-10-27 |
| AMBU HAND POWER SUCTION PUMP (K992902) | Ambu, Inc. | 1999-10-25 |
| PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM (K993220) | Puritan Bennett Corp. | 1999-10-22 |
| SIMS PORTEX EPIDURAL CATHETER, 20G MODEL# 4910-16/17; 21G MODEL# 4910-18 (K992471) | Sims Portex, Inc. | 1999-10-22 |
| VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM (K983627) | Invacare Corp. | 1999-10-22 |
| HTU3 (K984313) | Hyox Systems , Ltd. | 1999-10-22 |
| OPAP (K991926) | Opap, Inc. | 1999-10-18 |
| ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM (K992723) | Transfusion Technologies Corp. | 1999-10-18 |
| PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI (K993088) | Puritan Bennett Corp. | 1999-10-08 |
| ETCO2 VITAL SIGNS MODULE (K983864) | Mennen Medical, Inc. | 1999-10-08 |
| SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER (K992986) | Salter Labs | 1999-09-24 |
| PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040) (K990960) | Perimed, Inc. | 1999-09-23 |
| E100M VENTILATOR (E100M) (K972833) | Newport Medical Instruments, Inc. | 1999-09-23 |
| OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (K992670) | Instrumentation Industries, Inc. | 1999-09-17 |
| BEAR CUB 750 PSV (K992788) | Bear Medical Systems, Inc. | 1999-09-16 |
| FRESH AIR (K981047) | Colorado Medtech, Inc. | 1999-09-16 |
| AEROCHAMBER PLUS VALVED HOLDING CHAMBER (K992917) | Trudell Medical Int'L | 1999-09-14 |
| HAMILTON MEDICAL GALILEOVENTILATOR (K982910) | Hamilton Medical, Inc. | 1999-09-14 |
| COLLINS CPL (K992743) | Collins Medical, Inc. | 1999-09-13 |
| KION ANESTHESIA SYSTEM (K973971) | Siemens Medical Solutions USA, Inc. | 1999-09-13 |
| IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 (K992057) | Sims Portex, Inc. | 1999-09-13 |
| COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION (K991986) | Cobe Cardiovascular, Inc. | 1999-09-09 |
| POCKETSPACER (K992038) | Ferraris Medical, Inc. | 1999-09-09 |
| SHINMED MODEL SW-966 ULTRASONIC NEBULIZER (K980024) | Shining World Health Care Co., Ltd. | 1999-09-03 |