Atlas FDA

1992

3,665 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT (K920504)Medix Biotech, Inc.1992-03-02
SRI TESTOSTERONE ENZYME IMMUNOASSAY (K915164)Serono-Baker Diagnostics, Inc.1992-03-02
DW236-34 ALLOY FOR PORCELAIN FUSED TO METAL (K920560)Invoclar North America, Inc.1992-03-02
SR-ISOSIT SPECTRA LINK SYSTEM (K910069)Ivoclar North America, Inc.1992-03-02
DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. (K920561)Ivoclar North America, Inc.1992-03-02
SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) (K914886)Serono-Baker Diagnostics, Inc.1992-03-02
KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM (K914728)Eastman Kodak Company1992-03-02
IMPROVED DENTAL OPERATING LIGHT (K920017)Den-Tal-Ez Mfg Co., Inc.1992-03-02
PRISMA UNIVERSAL BOND(R) 3 (K915830)Dentsply Intl.1992-03-02
CW DOPPLER 2.25 MHZ PROBE (K903562)Diasonics, Inc.1992-03-02
TSH CONTROL (K915325)Polymedco, Inc.1992-03-02
CRITIC-AID WOUND DRESSING (K912506)Sween Corp.1992-03-02
RETINA TESTER (K914393)Retina Tester1992-03-02
IMPROVED DENTAL CHAIR (K920016)Den-Tal-Ez Mfg Co., Inc.1992-03-02
TURBIQUANT (K920124)Behring Diagnostics, Inc.1992-03-02
FLO-GARD(R) 6301 (K915523)Baxter Healthcare Corp1992-02-28
RTS TECHNOLOGY MODELS 721,722,723,724 (K914578)Rts Technology, Inc.1992-02-28
SKIN STAPLE REMOVER KIT (K915430)Cypress Medical Products, Ltd.1992-02-28
INTRADUCER (K920040)Taut, Inc.1992-02-28
DL100 C02 SURGICAL LASER SYSTEM (K915085)Mnlase, Inc.1992-02-28
RAMBACH AGAR (K912924)Rantran, Inc.1992-02-28
FLO-GARD(R) 6201 (K915522)Baxter Healthcare Corp1992-02-28
INSTRUMENT ORGANIZER (K914960)O.R. Concepts, Inc.1992-02-28
DAVOL ELECTROSUGICAL PROBES (K915406)Davol, Inc.1992-02-28
METAL URETERAL BASKET STONE DISLODGER, FLAT WIRE (K914112)Annex Medical, Inc.1992-02-28
METAL URETERAL BASKET STONE DISLODGER, HELICAL (K914111)Annex Medical, Inc.1992-02-28
GRASPING FORCEPS (K914110)Annex Medical, Inc.1992-02-28
CORTICAL BONE SCREW (K915448)Dow Corning Wright1992-02-28
XPR PRINTER REDUNDANCY (K914444)Vortech Data, Inc.1992-02-27
MEDRAD PATHFINDER HR ROADMAPPING SYSTEM (K914366)Medrad, Inc.1992-02-27
ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT (K914404)Lunar1992-02-27
ALTAIR (K912728)Diagnostic Medical Instruments1992-02-27
STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES (K914531)Arrow Intl., Inc.1992-02-27
S.A.A. EYE GLASS FRAMES (K915783)Yau Yee Optical Co., Ltd.1992-02-27
INSTRUMENTARIUM MEGA4 (K915552)Instrumentarium Imaging, Inc.1992-02-27
ENZYGNOST(R) ANTI-CMV/IGM (K913693)Behring Diagnostics, Inc.1992-02-27
PSG(TM) 20 GUAGE DOPPLER NEEDLE (K913941)Peripheral Systems Group1992-02-27
CANNABINOID EIA TEST (K920311)Diagnostic Reagents, Inc.1992-02-27
MEDIQUIP I.A. FIELD CONV KIT/AMSCO 2080 SER TABLE (K914417)Med-Vac, Inc.1992-02-27
FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM (K915535)Lunar1992-02-27
IN THE EAR HEARING AID (K915450)Zenith/Omni Hearing Instruments, Inc.1992-02-27
CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS (K915644)Nuccardiac Software, Inc.1992-02-27
STERILETX POWDER FREE LATEX EXAMINATION GLOVES (K915189)Transcorp1992-02-27
EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY (K920507)Syva Co.1992-02-27
SYTEC DENTASCAN (K914305)General Electric Co.1992-02-27
EXTEND-EAR (K920466)Sonovation, Inc. Dba Avr Sonovation1992-02-27
LASER SYSTEMS FOR PERCUTANEOUS LUMBAR DISCECTOMY (K912618)Heraeus Lasersonics, Inc.1992-02-27
GUIDEWIRE INTRODUCER SET (K915421)B. Braun of America, Inc.1992-02-27
APEX HELIX - A (K914807)Elscint, Inc.1992-02-27
IL TEST CANNABINOID, 35282 (K920418)Instrumentation Laboratory CO1992-02-27
TOUCH TALKER (K914259)Prentke Romich Co.1992-02-27
SPECTACLE FRAMES+ SUNGLASSSES(NON PRESC.) (K914954)Jsu Corp.1992-02-27
DESERET GUIDEWIRE INTRODUCER (K915496)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-27
IR-192 IMPLANT, MODIFICATION (K915253)Omnitron Intl., Inc.1992-02-27
XENON CIRCUIT (K914747)Gibeck, Inc.1992-02-27
ACID PHOSPHATASE REAGENT SET (K915705)Tech Intl. Co.1992-02-27
PURITAN-BENNET INFANT MANUAL RESUSCITATOR MODIFIED (K920570)Puritan Bennett Corp.1992-02-27
OPTION U1 FOR THE DPS-PLUS SYSTEM (K915305)Adac Laboratories1992-02-26
MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS (K912685)Nihon Kohden America, Inc.1992-02-26
AIRWAY THERMISTOR (K914219)Synectics-Dantec1992-02-26
CATHWRITER(TM) (K914105)Softheart, Inc.1992-02-26
PIKOS 01 & PIKOS E 01 (K914109)Biotronik, GmbH & Co.1992-02-26
SENSORMEDICS OXYSHUTTLE II(TM) (K913790)Sensor Medics Corp.1992-02-26
AMMONIA REAGENT SET (K915707)Tech Intl. Co.1992-02-26
THAYER EXPANSION CHAMBER METERED DOSE INHALER (K914283)Thayer Medical Corp.1992-02-26
IONOFIL/LONOFIL MOLAR (K915619)Voco GmbH1992-02-25
GASTROINTESTINAL TUBE AND ACCESSORIES (K914492)Sandoz Nutrition1992-02-25
NMC CYCLER MACHINE (K905809)National Medical Care, Medical Products Div., Inc.1992-02-25
EZ GOLD (K915626)Ivoclar North America, Inc.1992-02-25
NASOGASTRIC FEEDING TUBE KITS (K915439)Sandoz Nutrition1992-02-25
NASOJEJUNAL FEEDING TUBE W/GASTRIC DRAINAGE (K913407)Sandoz Nutrition1992-02-25
PROVICOL (K915618)Voco GmbH1992-02-25
ACCESS IMPRESSION BARREL (K913974)Centrix, Inc.1992-02-25
EXCEL MODEL XLT-ONE ND:YAG LASER SYSTEM (K914849)Excel Tech. , Ltd.1992-02-25
FEEDING TUBE Y-PORT CONNECTOR (K915438)Sandoz Nutrition1992-02-24
URETHRALPRESSURE PROFILE CATHETER (K915484)Life-Tech Intl., Inc.1992-02-24
STERILE DISPOSABLE WET SKIN SCRUB TRAY (K914174)Medical Device Inspection Co., Inc.1992-02-24
URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL (K912888)Dynagen, Inc.1992-02-24
STERILE CUSTOM SURGICAL KITS (K914244)Ulti-Med Intl., Inc.1992-02-24
SELECTACUT BIOPSY DEVICE (K914215)Biomni Medical Systems, Inc.1992-02-24
DRS-4 DIALYZER REPROCESSING SYSTEM (K914580)Seratronics, Inc.1992-02-24
VISITEC CANALICULAR STENT (K915809)Visitec Co.1992-02-24
LATERALASE (K915354)Trimedyne, Inc.1992-02-24
PHACO 20/20 SYSTEM I (K915457)Innovative Medical Systems, Inc.1992-02-24
SILVER FOAM WOUND DRESSING (K914579)Vitaphore Corp.1992-02-21
OPACITRAC (K915356)Oculon Corp.1992-02-21
CAPIOX LEVEL ALARM (K915337)Terumo Medical Corp.1992-02-21
PEDIATRIC DISPOSABLE EXTERNAL DEFIBRILATION/ECG (K912966)Physio-Control Corp.1992-02-21
SURGICAL ELECTRICAL PENCIL (K913623)Aaron Medical, Inc.1992-02-21
VENTREX ALLERGEN DISC (K913833)Ventrex Laboratories, Inc.1992-02-21
NGM ESTP MODULE (K911646)Datex Division Instrumentarium Corp.1992-02-21
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG) (K915851)Quidel Corp.1992-02-21
ECONOMATE/PATRIOT (K912794)Foothills Medical Equipment, Inc.1992-02-21
STORZ MICRO CUTTER 25 GAUGE PACK (K913504)Storz1992-02-21
MULTILASE 2100 A (K913290)Teknomed, Inc.1992-02-21
MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEM (K912879)Sunrise Technologies, Inc.1992-02-21
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING (K915553)C.R. Bard, Inc.1992-02-21
XENON ARC ENDOSCOPE LIGHT SOURCE (K920403)Medical Device Inspection Co., Inc.1992-02-21
URIC ACID REAGENT SET (K914158)Tech Intl. Co.1992-02-21
RSP MEGA SAMPLE PROCESSOR (K915492)Tecan U.S., Ltd.1992-02-21
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Every clearance here is in the API, with alerts when new ones post.