| OXI-SNAP (K971184) | Snap Laboratories, LLC | 1997-10-01 |
| SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES (K971808) | Monarch Medical | 1997-09-26 |
| POCKET RESCUE (K970688) | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| SANPO I (K964541) | Koike Medical Co. | 1997-09-26 |
| SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF (K971267) | Mallinckrodt Medical | 1997-09-25 |
| PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM WITH PARATREND 7 PLUS MULTIPARAMETER SENSOR (K970906) | Diametrics Medical, Ltd. | 1997-09-23 |
| CAPNOXYGEN MASK (K971229) | Medsys, Inc. | 1997-09-23 |
| EZ SPRAY (K972397) | Intertex Research, Inc. | 1997-09-23 |
| ONE-WAY VALVE (WITH CONNECTOR) (K970780) | Instrumentation Industries, Inc. | 1997-09-18 |
| SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT (K972283) | Sims | 1997-09-17 |
| DRAGER-VAPOR 2000 (K971923) | Draeger Medical, Inc. | 1997-09-16 |
| NELLCOR PURITAN BENNETT GEMINI (K972248) | Nellcor Puritan Bennett, Inc. | 1997-09-12 |
| HP ORVUE INTRA-OP (M2510A) (K965160) | Hewlett-Packard GmbH | 1997-09-11 |
| NARKOMED M ANESTHESIA SYSTEM (M) (K971425) | Draeger Medical, Inc. | 1997-09-10 |
| COSMED K4 (K963373) | Cosmed Srl | 1997-09-10 |
| AMSINO SUCTION CATHETER (K973199) | Amsino Intl., Inc. | 1997-09-10 |
| SULLIVAN HUMIDAIRE HEATED HUMIDIFIER (K971260) | Resmed Corp | 1997-09-04 |
| ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP (K972139) | Davis & Geck, Inc. | 1997-09-03 |
| BRONCHIAL BLOCKER (K962167) | Cook, Inc. | 1997-08-29 |
| SODIUM CHLORIDE INHALATION SOLUTION, USP (K972466) | Holopack International, LP | 1997-08-28 |
| STERILE WATER FOR INHALATION, USP (K972467) | Holopack International, LP | 1997-08-28 |
| EVITA 2 DURA (K970165) | Drager, Inc. | 1997-08-26 |
| T-WALL UNCUFFED TRACHEAL TUBE (K970196) | Vital Signs, Inc. | 1997-08-21 |
| ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR (K972371) | Brasamerica Medical Equipment, Inc. | 1997-08-19 |
| OXLIFE EXCELL OXYGEN CONCENTRATORS (K971964) | Oxlife, Inc. | 1997-08-15 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311 (K972086) | Alexander Mfg. Co. | 1997-08-12 |
| ANODYNE CC (K963481) | Heyer America, Inc. | 1997-08-11 |
| MDILOG, MODEL MDC-511 (K970344) | Medtrak Technologies, Inc. | 1997-08-06 |
| PARI PEP THERAPY SYSTEM (K972042) | Pari Holding Co. | 1997-08-05 |
| REGANES SPINAL NEEDLE (VARIOUS) (K971645) | Avid N.I.T., Inc. | 1997-08-01 |
| PORT-NEB (K971933) | Medic-Aid , Ltd. | 1997-08-01 |
| HAND HELD MEDISPACER (K972237) | Thayer Medical Corp. | 1997-07-31 |
| TMS COMFORT SERIES NASAL CPAP MASK (K964092) | Tiara Medical Systems, Inc. | 1997-07-31 |
| PROTEGE LIQUID OXYGEN SYSTEM (K971545) | Healthdyne Technologies, Inc. | 1997-07-25 |
| CPROTECTOR 2000 (K960587) | Certified Safety Mfg., Inc. | 1997-07-21 |
| SCT 3000 HEATED HUMIDIFIER (K970478) | Marquest Medical Products, Inc. | 1997-07-16 |
| FLOTEC OXYSAVRR (S) (K970371) | Flotec, Inc. | 1997-07-10 |
| MANUAL RESUSCITATOR (K963848) | Owens-Brigam Medical Co. | 1997-07-07 |
| PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA (K963732) | Mallinckrodt Medical | 1997-06-26 |
| FILTER (K970102) | Promedic, Inc. | 1997-06-24 |
| THAIRAPY VEST SYSTEM (K965192) | American Biosystems, Inc. | 1997-06-24 |
| MASTER NEB II (K970542) | Bremed Italia, S.R.L. | 1997-06-24 |
| OXYPURE PORTABLE OXYGEN GENERATOR (K971129) | Arbor Research Corp. | 1997-06-24 |
| SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM (K970771) | Resmed, Ltd. | 1997-06-20 |
| MORPHEE PLUS ALPHA (K964019) | Nellcor Puritan Bennett, Inc. | 1997-06-18 |
| KEY CHAIN EMERGENCY AIRWAY (K962312) | Ffrench Pocket Emergency Airway, Inc. | 1997-06-17 |
| OHMEDA APAC (ADVANCED PORTABLE ANESTHESIA CARE) SYSTEM (K965041) | Ohmeda Medical | 1997-06-17 |
| MICRODL DIARYCARD SPIROMETER (K965042) | Micro Direct, Inc. | 1997-06-17 |
| DATEX ENGSTOM MANUAL RESUSCITATOR (K970991) | Promedic, Inc. | 1997-06-16 |
| C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SET (K971274) | Fresenius AG | 1997-06-13 |
| SIMS HYPERINFLATION BAG SYSTEM (K970785) | Sims | 1997-06-13 |
| DEVILBISS 8650D (K963349) | Devilbiss Health Care, Inc. | 1997-06-13 |
| INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT) (K970959) | Instrumentation Industries, Inc. | 1997-06-13 |
| PEAK FLOW METER (K970507) | Intl. Medical, Inc. | 1997-06-13 |
| MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER (K961779) | Avion Medical Products, Inc. | 1997-06-13 |
| MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717) | Millipore Corp. | 1997-06-10 |
| DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) (K951928) | Csen , Ltd. | 1997-05-30 |
| COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER) (K951927) | Csen , Ltd. | 1997-05-30 |
| WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM (K952545) | Wright Industries | 1997-05-28 |
| NEO-CARE LUMBER PUNCTURE KIT (K970997) | Klein-Baker Medical, Inc. | 1997-05-22 |
| SCOPETEX(TM) (K945590) | Smith Helms Mulliss & Moore, L.L.P. | 1997-05-20 |
| DHD EMERALD PRODUCT (K970596) | Dhd Diemolding Healthcare Div. | 1997-05-16 |
| AMBU SPUR NEONATE (K964584) | Ambu, Inc. | 1997-05-15 |
| MODEL 405T WITH ETCO2 OPTION (K964961) | Ivy Biomedical Systems, Inc. | 1997-05-14 |
| COMBINATION OXIMETER/CARBON DIOXIDE GAS ANALYZER (K964239) | Spegas Industries, Ltd. | 1997-05-09 |
| SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM (K970516) | Resmed, Ltd. | 1997-05-09 |
| AS/3 NMT MODULE (K955026) | Datex Medical Instrumentation, Inc. | 1997-04-28 |
| MODEL 1920 WASTE GAS SCAVENGER (K963601) | G. Dundas Co. | 1997-04-28 |
| E-Z SPACER MASK (SMALL) (K964956) | Airpharma, LLC | 1997-04-23 |
| PLEUR-EVAC SAHARA PLUS MODEL S-1150 CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM (K963850) | Deknatel, Inc. | 1997-04-22 |
| CAPNOCHECK PLUS (K970209) | Bci Intl., Inc. | 1997-04-18 |
| MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (K961972) | Aequitron Medical, Inc. | 1997-04-18 |
| QUARTET CLINICAL SYSTEM (K963761) | Respironics, Inc. | 1997-04-18 |
| OPTIVENT (K963793) | Health Care Products, Inc. | 1997-04-16 |
| MODEL 1700 TRANQUILITY BILEVEL SYSTEM (K970173) | Healthdyne Technologies, Inc. | 1997-04-16 |
| HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402) (K964382) | Gibeck, Inc. | 1997-04-15 |
| COMPRESSOR/NEBULIZER #3650 (K970289) | Devilbiss Health Care, Inc. | 1997-04-15 |
| POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (K961790) | Optical Sensors, Inc. | 1997-04-09 |
| SPIRACLE TECHNOLOGY - MODEL 302 OX INHALATOR (K963755) | Spiracle Technology | 1997-04-08 |
| SYRINGEFILTER (K960928) | Arbor Technologies, Inc. | 1997-04-04 |
| TONOCAP, TC-200 AND ACCESSORY CATHETERS (K962638) | Instrumentarium Corp. | 1997-04-04 |
| VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101 (K964360) | Novametrix Medical Systems, Inc. | 1997-04-04 |
| PERIFIX PEDIATRIC EPIDURAL KIT (K962696) | B.Braun Medical, Inc. | 1997-04-03 |
| MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR (K954120) | Magnetic Resonance Equipment Corp. | 1997-04-02 |
| JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 (K970035) | Graham-Field, Inc. | 1997-04-01 |
| FPT NEBULIZER (K970010) | Fluid Propulsion Technologies, Inc. | 1997-04-01 |
| BENCHMARK TRANSFER TEST (K954730) | P.K. Morgan , Ltd. | 1997-04-01 |
| C.E. VASCULAR MACHINE (K960840) | C.E. Diagnosis, Inc. | 1997-03-28 |
| NASALFLAIR (K951944) | Airways Ltd., Inc. | 1997-03-28 |
| CUFFED OROPHARYNGEAL AIRWAY (COPA) (K955721) | Mallinckrodt Medical | 1997-03-28 |
| PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U) (K965239) | Accutron, Inc. | 1997-03-28 |
| UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) (K970046) | Accutron, Inc. | 1997-03-28 |
| HI-LO EVAC AND EVAC II ENDOTRACHEAL TUBES (K965132) | Mallinckrodt Medical | 1997-03-20 |
| TRANSTRACHEAL CATHETER (ACC. RAVUSSIN). (K955461) | VBM Medizintechnik GmbH | 1997-03-19 |
| TUOHY EPIDURAL NEEDLES (K961152) | Hakko Shoji Co., Ltd. | 1997-03-19 |
| SPINAL NEEDLES (K961151) | Hakko Shoji Co., Ltd. | 1997-03-19 |
| THE SWIRLER NEBULIZER (K952910) | Amici, Inc. | 1997-03-19 |
| NARKOMED GS ANESTHESIA SYSTEM (K963994) | Draeger Medical, Inc. | 1997-03-19 |
| REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142 (K963347) | Instrumentation Industries, Inc. | 1997-03-19 |
| MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM (K965251) | Medtronic Vascular | 1997-03-18 |