Atlas FDA

1995

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

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RecordFirmDate
HICHEM LDH/L REAGENT KIT (K946022)Hichem Diagnostics1995-02-23
BASIC REUSABLE TROCAR SYSTEM (K950500)Endoscopic Concepts, Inc.1995-02-23
IMMULITE(R) ALLERGY FOOD PANEL FP5E (K943194)Diagnostic Products Corp.1995-02-23
ENDCUP (K945862)Lewtek1995-02-23
ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (K921695)Parker Laboratories, Inc.1995-02-23
FUKUDA SANGYO MODEL SPIROANALYZER ST-180 (K943546)Spirosoft Northamerica, Inc.1995-02-23
VISITEC SCLERAL PLUG (K945114)Visitec Co.1995-02-23
VASOGENICS EECP-MC2 (K940264)Vasogenics, Inc.1995-02-23
HEMAGEN ENA SS-A KIT (EIA METHOD) (K946121)Hemagen Diagnostics, Inc.1995-02-22
DRUGS OF ABUSE CALIBRATOR (K950139)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (K946066)Cholestech Corp.1995-02-22
ABUSIGN DOA4 (K943439)Princeton BioMeditech Corp.1995-02-22
MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE (K940548)Medical Innovations Corp.1995-02-22
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL (K950399)Bionostics, Inc.1995-02-22
EMIT(R) IIC AMPHETAMINE ASSAY (K935352)Syva Co.1995-02-22
HEMAGEN ENA SS-B KIT (EIA METHOD) (K946120)Hemagen Diagnostics, Inc.1995-02-22
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK (K944697)Organon Teknika Corp.1995-02-22
OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE (K950166)Olympus America, Inc.1995-02-22
HEMAGEN ENA JO-1 KIT (EIA METHOD) (K946124)Hemagen Diagnostics, Inc.1995-02-22
DSL ACTIVE IGFBP-3 IRMA (DSL 6600) (K950228)Diagnostic Systems Laboratories, Inc.1995-02-22
TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (K946065)Cholestech Corp.1995-02-22
TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (K946063)Cholestech Corp.1995-02-22
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS) (K941762)Hogan & Hartson1995-02-22
CVPRO CARDIOVASCULAR PATCH (K943736)W. L. Gore & Associates, Inc.1995-02-22
DRUGS OF ABUSE CONTROLS (K950138)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
EMIT IIC PHENCYCLIDINE ASSAY (K935191)Syva Co.1995-02-22
EMIT IIC COCAINE METABOLITE ASSAY (K935323)Syva Co.1995-02-22
EMIT IIC BARBITURATE ASSAY (K935116)Syva Co.1995-02-22
ABUSIGN(TM) COC, DOA-COC, ACCUSIGN(TM) COC, DOA-COC, DIOSIGN(TM) COC, DOA-COC (K945609)Princeton BioMeditech Corp.1995-02-22
HANDYPACK 911SC (K944541)Pace Tech, Inc.1995-02-22
TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (K946067)Cholestech Corp.1995-02-22
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC (K944851)Rexton, Inc.1995-02-22
ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC (K945550)Princeton BioMeditech Corp.1995-02-22
SUNGLASSES (K946381)Ialin Optical Mfg., (H.K.) Co. , Ltd.1995-02-22
CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER (K946183)Heraeus Kulzer, Inc.1995-02-22
NON-UNIFORM ATTENUATION CORRECTION SYSTEM (K942145)Siemens Medical Solutions USA, Inc.1995-02-22
EMIT IIC CANNABINOID ASSAY (K940158)Syva Co.1995-02-22
RADIAS TOTAL T4 ENZYME IMMUNOASSAY (K946163)Bio-Rad1995-02-22
TOTAL CHOLESTEROL CASSETTE (K946064)Cholestech Corp.1995-02-22
HEMAGEN ENA SM KIT (EIA METHOD) (K946123)Hemagen Diagnostics, Inc.1995-02-22
340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER (K945408)Catachem, Inc.1995-02-22
LIFESIGN, CARE POINT, VITALSIGN, ACCUSIGN (K944325)Princeton BioMeditech Corp.1995-02-22
VAPOFIL (K945993)Southmedic, Inc.1995-02-22
DIGOXIN FLEX(TM) REAGENT CARTRIDGE (K946153)E.I. Dupont DE Nemours & Co., Inc.1995-02-22
HEMAGEN ENA SCL-70 KIT (EIA METHOD) (K946122)Hemagen Diagnostics, Inc.1995-02-22
503 MAXI COMPRESSOR (K940630)Medical Industries America, Inc.1995-02-21
ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES (K944487)Prizm Medical, Inc.1995-02-21
PACIFIER-THERMOMETER (K943362)Questech Intl., Inc.1995-02-21
A4722 OLYMPUS OPTICAL OBTURATOR (K950055)Olympus America, Inc.1995-02-21
SURGICAL SAW BLADES (K950403)Transidyne General Corp.1995-02-21
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (K924679)Air-Shields Vickers, Inc.1995-02-21
PHOTOTHERAPEUTIX MODEL 2400B (K933954)Avex Industries , Ltd.1995-02-21
MODEL 6100 AMBULATORY INFUSION SYSTEM (K943310)Pharmacia Deltec, Inc.1995-02-21
CAPNOSAT (K942849)Spegas Industries, Ltd.1995-02-21
SCANNING DIRECTOR (K944585)Prentke Romich Co.1995-02-21
PHOTOTHERAPEUTIX MODEL 1650B (K933953)Avex Industries , Ltd.1995-02-21
DISPOSABLE ASPIRATION/IRRIGATION CATHETER (K934154)Neuro Navigational Corp.1995-02-21
4-O2 PLUS (CPR) MOUTH BARRIER, CATALOG NO. 08050 (K950392)Cal West Trading Co.1995-02-21
KERRISON RONGEURS (K943583)Enterprise Medical Corp.1995-02-21
FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT (K950447)Vital Signs, Inc.1995-02-21
SMD ELECTRODES (K943009)Scientific Medical Devices, Inc.1995-02-21
SINOJET MAXILLARY SINUS PUNCTURE & IRRIGATION SYSTEM (K942495)Atos Medical AB1995-02-21
AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H (K945359)Artema Medical AB1995-02-21
CUTANEOUS ELECTRODE (K941986)Maxxim Medical1995-02-21
INTRODUCER NEEDLE (SEVERAL SIZES) (K933522)Mediziv Medical Products 1987 , Ltd.1995-02-21
MICOS MICROPULSE(TM) ALTERNATING PRESSURE WHEELCHAIR CUSHION (K945667)Micos Medical Systems1995-02-21
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE (K944861)KARL STORZ Endoscopy-America, Inc.1995-02-21
PHOTOTHERAPEUTIX MODEL 800B (K933952)Avex Industries , Ltd.1995-02-21
ULTIMAX (GREEN POWDER FREE EXAMINATION) (K943869)Wembley Rubber Products (M) Sdn Bhd1995-02-21
CPR MICROMASK (K943386)Plasco, Inc.1995-02-21
AD PERFECT (K940768)Chimera Research & Chemical, Inc.1995-02-17
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM (K946011)Argus Medical Co., Inc.1995-02-17
EPISTAXIS BALLOON CATHETER WITH PACKING (K945554)Ultracell Medical Technologies, Inc.1995-02-17
MEDSAT OXYGEN SATURATION SYSTEM (K941922)Medtronic Bio-Medicus, Inc.1995-02-17
THE HILL HI-LO TABLE (K934754)Hill Laboratories Co.1995-02-17
CABLE-EASE PLATE AND CABLE SYSTEM (K944529)Intermedics Orthopedics1995-02-17
THE HILL ADJUSTABLE AIR-FLEX MODEL (K932810)Hill Laboratories Co.1995-02-17
A3 ANKLE CPM UNIT (K945121)Toronto Medical, Inc.1995-02-17
BACT/ALERT FAN CULTURE BOTTLE (K944594)Organon Teknika Corp.1995-02-17
MAGNATHERM MODEL 1000 SS (K934151)Intl. Medical Electronics , Ltd.1995-02-17
VASCULAR ACCESS CATHETER ACCESSORIES (K935380)Bard Access Systems, Inc.1995-02-17
BRANEMARK SYSTEM SMILINE II (K944963)Nobelpharma USA, Inc.1995-02-17
NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECTRODES, AND CORDS (K945694)American Hydro-Surgical Instruments, Inc.1995-02-17
NON-PRESCRIPTION SUNGLASSES (K941266)Gbs Corp.1995-02-17
ECHOCARDIOGRAPHY (K945163)Tri W-G, Inc.1995-02-17
NON-PRESCRIPTION SUNGLASSES (K941267)Topstar Trading , Ltd.1995-02-17
NICOM DIGITAL IMAGE MANAGER (K945654)Camtronics, Ltd.1995-02-17
PHOTOTHERAPEUTIX MODEL 1600B (K935526)Avex Industries , Ltd.1995-02-17
ANGIOGRAPHIC SYSTEM (K944952)Acoma Medical Imaging, Inc.1995-02-17
EXPANDACELL NASAL PACK WITH AIRWAY (K950024)Shippert Medical Technologies Corp.1995-02-17
THE HILL ADJUSTABLE HA90E (K942026)Hill Laboratories Co.1995-02-17
PHOTOTHERAPEUTIX MODEL 3200A (K935524)Avex Industries , Ltd.1995-02-17
I.V. ROLLER GUARD CLAMP (K942446)Plastic Manufacturing and Marketing Group, Inc.1995-02-17
MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE (K943756)Alamar Biosciences, Inc.1995-02-17
KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER (K945890)KARL STORZ Endoscopy-America, Inc.1995-02-17
VIVAGLASS BASE (K950428)Ivoclar North America, Inc.1995-02-17
MODIFIED FOX EXTRA GRAM POSITIVE (K945997)Micro-Media Systems, Inc.1995-02-16
HARRY J. BOSWORTH RESIN I. (K946317)Harry J. Bosworth Co.1995-02-16
MILL-ROSE SCOPE CLEANING BRUSH (K946293)Mill-Rose Laboratory1995-02-16
DIENER RETRIEVAL DEVICES (K950559)Mill-Rose Laboratory1995-02-16
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Every clearance here is in the API, with alerts when new ones post.