Atlas FDA

1995

5,487 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES (K953496)Shield Gloves Manufacturer (M) Sdn Bhd1995-09-08
COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY (K936253)Light Diagnostics1995-09-08
COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY (K940472)Chemicon Intl., Inc.1995-09-08
MEDIX BIOTECH STREP A ANTIGEN DETECTION TEST (MODIFICATION) (K952873)Medix Biotech, Inc.1995-09-08
COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY (K936145)Chemicon Intl., Inc.1995-09-08
FORCEPS (K953962)Biopsys Medical, Inc.1995-09-08
PREVENTOR AND PROTECTOR LATEX CONDOMS (K945246)American Pharmaceutical Co., Inc.1995-09-07
REVOLUTION BOND (K953592)E&D Dental Products, Inc.1995-09-07
BOND-IT DUAL CURE ACTIVATOR (K953859)Jeneric/Pentron, Inc.1995-09-07
MTB 1043 TREATMENT BOOTH (K944133)Mark Solutions, Inc.1995-09-07
PPMI-(XXX) AND PPMO-(XXX) (K953231)Patriot Products, Inc.1995-09-07
HEARTCARD CARDIAC EVENT MONITOR (K944362)Instromedix, Inc.1995-09-07
TYPE 1 & 2 (HUMIDAIR I & II) (K953507)Icor AB1995-09-07
KARL STORZ SUCTION CATHETERS (K951250)KARL STORZ Endoscopy-America, Inc.1995-09-07
MARQUETTE DEFIB ELECTRODES (K952101)Marquette Electronics, Inc.1995-09-07
TROPICAIR CONVECTIVE WARING SYSTEM (K946196)Seabrook Medical Systems, Inc.1995-09-06
PARKER MODEL PM (K950376)Parker Treadmill Co., Inc.1995-09-06
CRONEX RADIATION THERAPY CASSETTE (K953724)E.I. Dupont DE Nemours & Co., Inc.1995-09-06
DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MM (K950476)Nikomed U.S.A., Inc.1995-09-06
CHESHIRE (K952778)Perceptive Systems, Inc.1995-09-06
PHACO TIP (K950881)American Optical Corp.1995-09-06
CRONEX RADIATION THERAPY VERIFICATION CASSETTE (K953725)E.I. Dupont DE Nemours & Co., Inc.1995-09-06
HICHEM ISE DILUENT KIT 70008 (K953860)Hichem Diagnostics1995-09-06
OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES (K951671)Osteonics Corp.1995-09-06
ACETAMINOPHEN ASSAY (K952949)Diagnostic Chemicals , Ltd.1995-09-06
URINARY METANEPHRINE KIT (K952919)Bioanalytical Systems, Inc.1995-09-06
KARL STORZ ENT SHAVER (K953370)KARL STORZ Endoscopy-America, Inc.1995-09-06
PRISM ELECTROSCOPE (K953849)KARL STORZ Endoscopy-America, Inc.1995-09-06
KONICA LASER IMAGER LI-21 (K950359)Storch Amini & Munves PC1995-09-06
TROPICAIR CONVECTIVE WARMING BLANKETS (K952086)Seabrook Medical Systems, Inc.1995-09-06
GLUCOSE TEST ITEM NUMBER 97375/94 (K951750)Emd Chemicals, Inc.1995-09-06
PARKER MODEL PE (K950377)Parker Treadmill Co., Inc.1995-09-06
3 LPM OXYGEN CONCENTRATOR (K952037)Devilbiss Health Care, Inc.1995-09-06
HICHEM ISE INTDERNAL REFERENCE KIT 70009 (K953861)Hichem Diagnostics1995-09-06
HICHEM ISE STANDARDS KIT 70011 (K953863)Hichem Diagnostics1995-09-06
HICHEM ISEKCI SOLUTION KIT 70010 (K953862)Hichem Diagnostics1995-09-06
LIGHT-CURE (K952858)Midwest Orthodontic Mfg.1995-09-05
VULCAN (K953594)Cmp Industries, LLC1995-09-05
LABORATORY SUPPLIES (K953380)Steri-Oss, Inc.1995-09-05
COVER GOWN (K952116)American Threshold Industries, Inc.1995-09-05
ELSA-HCT (K951708)Cis-Us, Inc.1995-09-05
MODEL A15-101 (K953191)Beaverstate Dental, Inc.1995-09-05
QUALICHECK 4 GLUCOSE (K952637)Radiometer America, Inc.1995-09-05
FLUOROSCAN NEONATAL (K950415)Isolab, Inc.1995-09-05
BIOSCAN (K952307)Biosys Laboratories, Inc.1995-09-05
AMPRI (K952833)Ampri Rubberware Industries Sdn Bhd1995-09-05
SEEK (K953526)Ultradent Products, Inc.1995-09-05
SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER (K952560)Sienco, Inc.1995-09-05
MODEL A15-103 (K953192)Beaverstate Dental, Inc.1995-09-05
MERTEX-PLUS O.R./SURGEONS GOWN (K953251)Mercana Industries , Ltd.1995-09-05
PRO-LOCK (K952857)Midwest Orthodontic Mfg.1995-09-05
BACK MASSAGER (K952043)Eight Corners, Inc.1995-09-01
GIP/MEDI-GLOBE ERCP CATHETERS (K953827)Medi-Globe Corp.1995-09-01
DYNATRON 850 (K941461)Dynatronics Research Corp.1995-09-01
STRYKER PRESSURE SENSING CANNULA (K944593)Stryker Endoscopy1995-09-01
UNIMAT PUMP (K953075)KARL STORZ Endoscopy-America, Inc.1995-09-01
DYNATRON 550 (K941577)Dynatronics Corp.1995-09-01
WALLACE IV CANNULA (K932946)Smiths Industries Medical Systems, Inc.1995-09-01
LEIBINGER STEREOPLAN PLUS STEROTACTIC TREATMENT PLAN ING SOFTWARE PACKAGE (K946033)Leibinger GmbH1995-09-01
POLLUX OA/POLLUX 30A/POLLUX 70A (K953484)Pollux Endoscopy, Inc.1995-09-01
ROGOZINSKI SPINAL ROD SYSTEM ROD-TO-BOLT (UNIVERSAL) CONNECTOR FOR USE WITH THE SIMMONS PLATING SYSTEM BOLT (K950865)Smith & Nephew Richards, Inc.1995-09-01
WALLACE Y-CAN (K932947)Smiths Industries Medical Systems, Inc.1995-09-01
MICRO-ARTHROSCOPE (K930084)Medical Devices, Inc.1995-09-01
QUANTA LITE IGA ACA (HRP) (K953366)Inova Diagnostics, Inc.1995-09-01
CASCASE 480 SNSLYZER (K951497)Helena Laboratories1995-09-01
DYNASORB (K951561)Dermarx Corp.1995-09-01
OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES (K951932)Osteonics Corp.1995-09-01
INNOVATIVE TECHNOLOGIES CALCIUM ALGINATE WOUND DRESSINGS (K953781)Innovative Technologies , Ltd.1995-09-01
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE BARE END FIBER (K952580)Gamp & Assoc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR (K952586)Gamp & Assoc.1995-09-01
TENDER TEMP (K951939)Investech, Ltd.1995-09-01
BIOINTEGRATOR, BIOINTEGRATOR PLUS (K942769)Bio Research Institute1995-09-01
MED-TECH LASER GAS MIXTURE (K953933)Medical Technical Gases Inc..1995-09-01
HARMAC EXTENSION INFUSION SET (K950895)Harmac Medical Products, Inc.1995-09-01
REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE (K951908)Regent Hospital Products1995-09-01
SF-CHECK (K952245)Streck Laboratories, Inc.1995-09-01
STRYKER UNIVERSAL ACL INSTRUMENTATION SYSTEM (K951267)Stryker Endoscopy1995-09-01
IMAGYN ENDOSCOPE (K951996)Imagyn Medical, Inc.1995-09-01
GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK (K952584)Gamp & Assoc.1995-09-01
MEDICAL GRADE SILICONE BLOCK (K952732)Bioplexus Corp.1995-08-31
ROTACHROM HEPARIN TEST KIT (K943515)American Bioproducts Co.1995-08-31
ROTACHROM HBPM/LMWH TEST KIT (K943516)American Bioproducts Co.1995-08-31
OSCILFLATOR (K952566)Surgical Technologies, Inc.1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K951950)Pacesetter, Inc.1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K952206)Pacesetter, Inc.1995-08-31
TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (K932571)Tomey Corporation USA1995-08-31
DUPONT LIPASE CALIBRATOR (K952815)Dupont Medical Products1995-08-31
SYNERMED CALCIUM REAGENT KIT (K953395)Synermed, Inc.1995-08-31
AMERIMED AS110 (K953069)Amerimed Systems L.C.1995-08-31
BONE MINERAL DENSITOMETER (K941362)Hologic, Inc.1995-08-30
MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL (K952459)Medtronic Vascular1995-08-30
QUIKSTRIP ONESTEP STREP A TEST IMMUNOCHROMA ASSAU (K935475)Syntron Bioresearch, Inc.1995-08-30
HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (K950624)Lifecore Biomedical, Inc.1995-08-30
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS (K952811)Implant Innovations, Inc.1995-08-30
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: COCRMO ALLOY (VITALIUM) BONE-MESH/PLATE & SCREWS (K952812)Implant Innovations, Inc.1995-08-30
MANAN NEPHROSTOMY DRAINAGE CATHETER (K953547)Manan Medical Products, Inc.1995-08-30
HEALTH IMAGE INC. HI STAR (K944724)Health Images, Inc.1995-08-30
QUIKPAC II ONESTEP STREP A IMMUNOCHROMATOGRAPHIC ASSAY (K935554)Syntron Bioresearch, Inc.1995-08-30
TRIUMPH-1 PORT (K951814)Horizon Medical Products, Inc.1995-08-29
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