Atlas FDA

1998

3,775 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SUPERGLOVES POWDERED NITRILE (K980966)Supermax Sdn Bhd1998-07-22
MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220 (K981493)Polymer Technology Systems, Inc.1998-07-22
ALBP (K981814)Abbott Laboratories1998-07-22
PLAYTEX SILK GLIDE ODOR ABSORBING FLUSHABLE CARDBOARD TAMPONS #13598 (K981760)Playtime Products, Inc.1998-07-22
GOODKNIGHT 418 CPAP SYSTEM (K980365)Nellcor Puritan Bennett, Inc.1998-07-22
REFRACTEC MCS-100 (K980522)Refractec, Inc.1998-07-22
CORE AND COIL ASSEMBLY GUIDEWIRE (K971322)Lake Region Mfg., Inc.1998-07-22
VCA IGG ELISA TEST SYSTEM (K980912)Clark Laboratories, Inc.1998-07-22
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM (K981750)Wieslab AB1998-07-22
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 (K981083)Biotronik, Inc.1998-07-22
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K981926)Emd Chemicals, Inc.1998-07-22
LAPARO-TENSER (K970712)L & T S.N.C. DI E. Lucini & C.1998-07-21
ITI STENT (K980290)Intratherapeutics, Inc.1998-07-21
EPILASER NORMAL MODE RUBY LASER (K980517)Palomar Medical Products, Inc.1998-07-21
MODEL 02 OXYGEN ANALYZER (K971084)Oxigraf, Inc.1998-07-21
CONTRAST CONTROL DEVICE (K982123)Medex, Inc.1998-07-21
WALLSTENT ENDOPROSTHESIS (K982184)Boston Scientific Scimed, Inc.1998-07-21
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (K974200)Orca Diagnostics Corp.1998-07-21
MPS HUBER NEEDLE EXTENSION SET (K982047)Medical Product Specialists1998-07-21
DORNIER MEDILAS E (K981438)Dornier Surgical Products, Inc.1998-07-20
STATUSFLOW (K982231)R&D Systems, Inc.1998-07-20
WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES (K980302)Richard Wolf Medical Instruments Corp.1998-07-20
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY (K981637)Linvatec Corp.1998-07-20
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT (K981030)The Binding Site, Ltd.1998-07-20
PRO VISION (K980648)Algotec Systems, Ltd.1998-07-20
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT (K981029)The Binding Site, Ltd.1998-07-20
OMNITECH RESECTOSCOPE ROLLER ELECTRODE (K981463)Omnitech Systems, Inc.1998-07-17
WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCRE (K981967)Arthrotek/Biomet, Inc.1998-07-17
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM (K981424)Nomos Corp.1998-07-17
SYNTHES (USA) DHS HELIX SYSTEM (K981757)Synthes (Usa)1998-07-17
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A (K981576)Hewlett-Packard GmbH1998-07-17
MEDICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSALE SEMI-AUTOMATIC BIOPDY INSTRUMENT (K982085)Medical Device Technologies, Inc.1998-07-17
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790 (K980668)Cryomedical Sciences, Inc.1998-07-17
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002 (K981730)Nk Biotechnical Corp.1998-07-17
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX (K981745)Sunscope Intl., Inc.1998-07-17
DIAMOND PROBE/PERIO 2000 SYSTEM (DEN980003)Diamond General Development Corp.1998-07-17
BIOLOX ALUMINA CERAMIC FEMORAL HEAD (K981847)Smith & Nephew, Inc.1998-07-17
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM (K980778)Johnson & Johnson Professionals, Inc.1998-07-17
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM (K970069)Ihd, Inc.1998-07-17
DORNIER MEDILAS H (K981718)Dornier Surgical Products, Inc.1998-07-17
BMC RF CANNULA (K972846)Baylis Medical Co., Inc.1998-07-17
EXTERNAL FIXATION (K981716)Avanta Orthopaedics, Inc.1998-07-17
Squirt Fluid Delivery System (K981417)Merit Medical Systems, Inc.1998-07-17
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722 (K980670)Cryomedical Sciences, Inc.1998-07-17
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR (K981602)Sunrise Medical Hhg, Inc.1998-07-17
NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/ HOLSTER, ES SMOKE & FLUID PENCIL W/ HOLSTER MODEL (K981614)Aaron Medical Industries1998-07-17
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM (K973430)Eastman Kodak Company1998-07-17
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ (K981641)Instrumentarium Corp.1998-07-17
COLORPAC TOXIN A (K980185)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-07-17
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED DELIVERY DEVICES (K972575)Laserscope1998-07-17
RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR (K981672)Radiotherapeutics Corp.1998-07-17
AMBU TUBECHECK (K981891)Ambu, Inc.1998-07-17
KNIGHTSTAR 335 (K973004)Puritan Bennett Corp.1998-07-16
LC POSITIONER (K981414)Fischer Imaging Corp.1998-07-16
CERVIX COIL LATEX SHEATH (K981406)Philips Medical Systems (Cleveland), Inc.1998-07-16
EQUINOXE (K980920)Bouvier Hydro, Inc.1998-07-16
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN) (K972700)Exmoor Plastics , Ltd.1998-07-16
OSCILLOMATE NIBP / SP02 EMS MONITOR (K980879)Cas Medical Systems, Inc.1998-07-16
SYNERGY LT (K981405)Oxford Instruments, Plc.1998-07-16
CPR FILTERSHIELD (K980066)Plasco, Inc.1998-07-16
AURORA DIODE LASER SYSTEM (K974586)Premier Laser Systems, Inc.1998-07-15
ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1 (K981381)Guidant Corp.1998-07-15
AVIVA SYSTEMS MODEL NUMBERS 1010, 2020 (K981533)American Telecare, Inc.1998-07-15
NTI CLENCHING SUPPRESSION SYSTEM (K981546)Heraeus Kulzer, Inc.1998-07-15
HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER (K974736)Heartport, Inc.1998-07-15
FLOW-EZE BLUNT CANNULA (1999BC) (K972538)Acacia, Inc.1998-07-15
OCULOSTAT (K981235)Laser Center Dev. Corp.1998-07-15
TYMPANOSTOMY TUBE (K981575)Grace Medical, Inc.1998-07-15
VACUETTE MULTIPLE SAMPLE LUER ADAPTER (K981619)Greiner Meditech, Inc.1998-07-15
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) (K972728)Bd Becton Dickinson Vacutainer Systems Preanalytic1998-07-15
BIOPSY M (K982049)Sitco, Inc.1998-07-14
SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T (K974457)Hewlett-Packard Co.1998-07-14
FLUOROSPOT COMPACT (K982028)Siemens Medical Solutions USA, Inc.1998-07-14
PAR-ONE (K981391)Remel, Inc.1998-07-14
XR-910 (K981466)Imaging Sciences Intl., Inc.1998-07-14
MEMBRANE TACK (K981459)Biomet, Inc.1998-07-14
AUTO-INJECTOR, SURE-INJECT 2000 (K981266)Mighty Mo, Corp.1998-07-14
0-20 CM H20 PEEP VALVE (K981415)Cheen Houng Ent. Co. , Ltd.1998-07-14
C3 EXTERNAL MALE BLADDER CONTROL DEVICE (K974040)Timm Research Co.1998-07-14
CAAS II LVA BIPLANE OPTION (K982203)Pie Medical Equipment B.V.1998-07-14
SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) (K974730)Graphic Controls Corp.1998-07-14
CARESIDE HDL-CHOLESTEROL (K981899)Exigent Diagnostics, Inc.1998-07-14
OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE (K981475)Toshiba America Mri, Inc.1998-07-14
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (K982250)Beckman Instruments, Inc.1998-07-14
CANDELA GENTLELASE GL DERMATOLOGICAL LASER (K981351)Candela Corp.1998-07-13
LM ANCHOR (K981764)Li Medical Technologies, Inc.1998-07-13
LORENZ PECTUS SUPPORT BAR STABILIZER (K981789)Walter Lorenz Surgical, Inc.1998-07-13
PRESSURE TRANSDUCER AIRFLOW SENSOR (K982293)Pro-Tech Services, Inc.1998-07-13
ELECTRONIC MUSCLE STIMULATOR - MICROSTIM J-1304D (K980040)Nisha Communication Industries1998-07-13
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS (K972401)Howmedica Corp.1998-07-13
HERMES OPERATING ROOM CONTROL CENTER WITH THE WOM 20L INSUFFLATOR (K980787)Computer Motion, Inc.1998-07-13
DEPUY GLOBAL SHOULDER GLENOID (K981487)DePuy Orthopaedics, Inc.1998-07-13
MAGNETIC PORT SILICONE TISSUE EXPANDER (K982067)Specialty Surgical Products, Inc.1998-07-13
ARTOSCAN S (K981358)Biosound Esaote, Inc.1998-07-13
LM ANCHOR (K981755)Li Medical Technologies, Inc.1998-07-13
POWERSTAR BIPOLAR SCISSORS (K981361)ETHICON, Inc.1998-07-13
SURGILON, DERMALON, & OPHTHALON (K981582)Davis & Geck, Inc.1998-07-13
ANSPACH SUTURE ANCHOR (K981688)The Anspach Effort, Inc.1998-07-13
LACTOSORB POP RIVET (K981798)Biomet, Inc.1998-07-13
SUTURE PLACEMENT DEVICE AND ACCESSORIES (K981531)Lsi Solutions1998-07-13
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