Atlas FDA

1998

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

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RecordFirmDate
CARDIOSMART ST (K973403)Marquette Medical Systems, Inc.1998-03-12
TS2000 MEDICAL DEVICE MONITOR (K973640)Trincore Systems, Inc.1998-03-12
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS (K974756)Biodynamic Technologies, Inc.1998-03-12
REUSABLE FINGER SENSOR 3444 (K974697)Bci Intl., Inc.1998-03-11
QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012 (K980532)Phamatech1998-03-11
FACEBOW (K980195)Ortho Kinetics Corp.1998-03-11
BAUSCH & LOMB WETTING AND SOAKING SOLUTION (K980133)Polymer Technology Corp.1998-03-11
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS (K974780)Bausch & Lomb, Inc.1998-03-11
ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B (K972603)Dr. Lee Co., Ltd.1998-03-11
CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 (K973999)Diagnostic Chemicals , Ltd.1998-03-11
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) (K970653)Baxter Healthcare Corp1998-03-11
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) (K970662)Baxter Healthcare Corp1998-03-11
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT (K980127)Catheter Innovations, Inc.1998-03-11
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER (K973238)Bill Olson Corp.1998-03-11
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE) (K980318)Hartalega Sdn Bhd1998-03-11
ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR (K974671)Athena Technology, Inc.1998-03-11
72 HOUR USE TRACH CARE WITH MICROBAN (K974630)Ballard Medical Products1998-03-11
TEMPORARY OCCLUSION BALLOON SYSTEM (K972777)Percu Surge, Inc.1998-03-11
BRUXTRAK MATERIAL (K974160)Bruxcare, LLC1998-03-11
CO-STAT(TM) END TIDAL BREATH ANALYZER (K974805)Natus Medical, Inc.1998-03-11
23:1 REDUCTION ANGLE (K973800)Midwest Dental Products Corp.1998-03-11
MULTITEST CD3/CD8/CD45/CD4 (K974360)Becton Dickinson Immunocytometry Systems1998-03-11
CREST TOOTHBRUSH WITH MICROSHIELD (K973236)Procter & Gamble Co.1998-03-11
FRIALIT-2 PROTECT ABUTMENT (K974628)Friatec AG1998-03-11
IMPOWER EXTERNAL VACUUM SYSTEM (K980291)Imagyn Medical Technologies, Inc.1998-03-11
PYLORI DETECT IGG (K973508)Micro Detect, Inc.1998-03-10
CARBON FIBER BREAST BOARD (K974703)Medtec, Inc.1998-03-10
RENU MULTIPLUS MULTI-PURPOSE SOLUTION (K974723)Bausch & Lomb, Inc.1998-03-10
ULTRABUR (K974174)Mednet Locator, Inc.1998-03-10
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K980026)Trace America, Inc.1998-03-10
VIDAS D-DIMER (DD) ASSAY (K973819)Biomerieux Vitek, Inc.1998-03-10
SIBELMED AC50D (K973377)Trutone1998-03-10
GEMINI STANDARD AND MINI VALVES (K974708)Neurocare Group1998-03-10
PLAQUAGRAFE, AGRAFE P4V (K974603)Atlas Technology1998-03-10
AEROETCHER (K973679)Parkell, Inc.1998-03-10
EPILASER I UPGRADE KIT (K980160)Palomar Medical Products, Inc.1998-03-10
TEMPO AND TEMP H20 (K973748)Smith1998-03-10
HEAT STACK (K980086)Medical Solutions, Inc.1998-03-10
OUTLOOK SYSTEM ENHANCEMENT PACKAGE (K974844)Philips Medical Systems (Cleveland), Inc.1998-03-10
DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL (K974781)Depuy, Inc.1998-03-10
AURORA TITANIUM SPINAL ROD SYSTEM (K974734)United States Surgical, A Division of Tyco Healthc1998-03-10
CARRARA PDF, CARRARA H, CARRARA R (K980597)European Dental Imports, Inc.1998-03-09
HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE (K974759)Hydrox Laboratories1998-03-09
ADC COMPACT (AGFA DIAGNOSTIC CENTER) (K974597)Bayer Corp., Agfa Div.1998-03-09
SYNERGY (K974465)Coltene/Whaledent, Inc.1998-03-09
FLOWABLE HYBRID (K980298)Cosmedent, Inc.1998-03-09
ENDOPATH ENDOSCOPIC TISSUE FASTENING SYSTEM (ETFS) (K980022)Ethicon Endo-Surgery, Inc.1998-03-09
CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET (K980123)Louisville Laboratories, Inc.1998-03-09
NON-WOVEN COMPRESS (K980382)Convatec, A Division of E.R. Squibb & Sons1998-03-09
H2O (K974587)Grass-Telefactor Product Group1998-03-09
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS (K980092)Smith & Nephew, Inc.1998-03-09
NP MEDICAL CAPLESS LUER ACTIVATED VALVE (K973916)Np Medical, Inc.1998-03-09
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L (K974789)Lumenis, Inc.1998-03-09
DAUM NEUROBIOPSY NEEDLE (K974631)Daum Corp.1998-03-09
PROGOLD ELECTROCOPING SYSTEM (K980613)Micro Dental Laboratories1998-03-09
PERSYST PRISM (K974718)Persyst Development Corp.1998-03-09
HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE (K974758)Hydrox Laboratories1998-03-09
DAUM BIOPSYGUN (K974576)Daum Corp.1998-03-06
AMPLATZ GOOSE NECK SNARE KIT/ CATHETER (K972511)Microvena Corp.1998-03-06
CARESIDE ANALYZER (K980056)Exigent Diagnostics, Inc.1998-03-06
DAUM NEUROPUNCTURE NEEDLE (K974574)Daum Corp.1998-03-06
AIMSTEP PREGNANCY (K980531)Germaine Laboratories, Inc.1998-03-06
DAUM ASPIRATIONBIOPSY NEEDLE (K974575)Daum Corp.1998-03-06
DIAMEDIX IS-RF TEST SYSTEM (K974889)Diamedix Corp.1998-03-06
ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) (K980190)Chiron Corp.1998-03-06
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (K974751)General Hearing Instruments, Inc.1998-03-06
IF-727 INTERFERENTIAL STIMULATOR (K974585)Skylark Device Co., Ltd.1998-03-06
RANDOX CREATININE (K973993)Randox Laboratories, Ltd.1998-03-06
OSTEOMARK (K980518)Ostex Intl., Inc.1998-03-06
MITEK BTB ABSORBABLE (PLA) CROSS PIN (K974291)Mitek Products1998-03-05
KANEDA ANTERIOR SCOLIOSIS SYSTEM KASS (K974757)Acromed Corp.1998-03-05
BIO-LOGIC CEEGRAPH 128-CHANNEL RECORDING SYSTEM (K973883)Bio-Logic Systems Corp.1998-03-05
ESOP S/C FEMORAL STEM (K964878)Fournitures Hospitalieres1998-03-05
20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE (K972185)Steripak, Ltd.1998-03-05
MEPIFORM ADHERENT SILICONE DRESSING FOR SCAR CARE (K974354)Sca Molnlycke1998-03-05
SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM (K973836)Cross Medical Products, Inc.1998-03-05
PSI-TEC ASPIRATOR (K980392)Byron Medical1998-03-05
TIR/TIJ AND POLYROX (K972500)Biotronik, Inc.1998-03-04
SHIMASONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM (K973802)Shimadzu Medical Systems1998-03-04
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT (K974311)Gyrus Ent LLC1998-03-04
GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102 (K974614)Elscint, Inc.1998-03-04
DYNA VUE 3-D IMAGING PRODUCT (K974755)Imd Systems, Inc.1998-03-04
SPECTRUM DESIGNS CLEFT CHIN IMPLANT (K980461)Spectrum Designs, Inc.1998-03-04
J-TIP NEEDLESS INJECTOR (K980082)National Medical Products, Inc.1998-03-04
BIOSENSOR HOLTER MONITOR SYSTEM (K974192)Biosensor Corp.1998-03-04
OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM (K971840)Invivo Research, Inc.1998-03-04
MATRIX MT-MX3 (K974700)Medtec, Inc.1998-03-04
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591)Morax1998-03-04
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER (K974625)Alcon Laboratories1998-03-04
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746 (K974624)Alcon Laboratories1998-03-04
HANDI OXYGEN ANALYZER (K973282)Ceramatec, Inc.1998-03-04
FLEXIGEL-G HYDROGEL WOUND DRESSING (K980097)Innovative Technologies , Ltd.1998-03-04
CYBERSONIC (K980075)American Dentronics, Inc.1998-03-04
IMPLANT SITE DILATORS (K980374)BioHorizons Implant Systems, Inc.1998-03-04
CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002 (K980514)Medical Analysis Systems, Inc.1998-03-04
BIOSENSOR HOLTER MONITOR SYSTEM (K974546)Biosensor Corp.1998-03-04
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM (K974558)Biomet, Inc.1998-03-04
ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 (K980031)Diagnostic Chemicals , Ltd.1998-03-03
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (K971522)Abbott Laboratories1998-03-03
SPECTRUM DESIGNS PROFILE MALAR IMPLANT (K980139)Spectrum Designs, Inc.1998-03-03
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Every clearance here is in the API, with alerts when new ones post.