Atlas FDA

1995

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

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RecordFirmDate
SAS FRANCISELLA TULARENSIS ANTIGEN (K952138)Sa Scientific, Inc.1995-07-17
STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT (K952250)Dade Intl., Inc.1995-07-17
ULTIMAX (K951473)Wembley Rubber Products (M) Sdn Bhd1995-07-17
SAS SALMONELLA H D ANTIGEN (K952135)Sa Scientific, Inc.1995-07-17
FREDEIC BEAUSOCEIL (K951551)Pascal Mathieux1995-07-17
ACTIVE INTACT PTH ELISA (K952199)Diagnostic Systems Laboratories, Inc.1995-07-17
GS & GS20 SURGICAL TOOL SYSTEM (K952463)Midas Rex Pneumatic Tools, Inc.1995-07-17
CERALAS DIODE LASER SYSTEM (MODEL CERALAS D50) (K951775)Ceram Optec, Inc.1995-07-17
OMS SLIMLINE PHACO HANDPIECE (K950218)Optical Micro Systems, Inc.1995-07-17
SPECTRADOP (K925078)Bennett and Assoc., Inc.1995-07-17
STC COCAINE METABOLITE EIA (K934775)Solarcare, Inc.1995-07-14
KIS-II IMPLANT FIXTURES (K951606)Implant Center of the Palm Beaches1995-07-14
AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) (K952211)Johnson & Johnson Clinical Diagnostics, Inc.1995-07-14
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 (K944957)Medtronic Blood Systems, Inc.1995-07-14
WATER JEL BURN KIT (K952561)Water-Jel Technologies, Inc.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE (K926253)Sudormed, Inc.1995-07-14
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 (K944956)The Heart Valve Div. Medtronic Cardiovascular Surg1995-07-14
BONE DRILL (K945706)Osteo Implant Corp.1995-07-14
DRESSING CHANGE TRAY (K952334)Busse Hospital Disposables, Inc.1995-07-14
ANEROID SPHYGMOMANOMETERS/MERCURIAL SPHYGMOMANOMETERSRS (K942543)Sankei Co., Ltd.1995-07-14
PRINCIPLE COMPONENT EEG ANALYSIS SOFTWARE (K951507)Neuroconcepts, Inc.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION (K935588)Sudormed, Inc.1995-07-14
QUANTITATIVE EEG ANALYSIS SOFTWARE (K951724)Neuroconcepts, Inc.1995-07-14
FILTERED EXTENSION SETS (K942988)B. Braun of America, Inc.1995-07-14
SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM (K951605)Spacelabs, Inc.1995-07-14
CAP-STIK (K934435)Mcshane Medical, Inc.1995-07-14
ORGANIC TAMPONS (K951924)Eco Yarn Co.1995-07-14
SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION (K935564)Sudormed, Inc.1995-07-14
PULPDENT GLASS IONOMER CEMENTS (K952854)Pulpdent Corp.1995-07-14
PRO-VENT, LINE DRAW, PULSATOR (K952516)Smiths Industries Medical Systems, Inc.1995-07-14
60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP (K952663)Distronic Sterile Products, Inc.1995-07-14
1.2MM DISPOSABLE NEUROVIEW(TM) PERFORMED ENDOSCOPE AND ACCESSORIES (K950154)Neuro Navigational Corp.1995-07-14
CITATION MULTIPLE USE DELTA SCOPE (K951941)Citation Medical Corp.1995-07-14
WELCH ALLYN FIBER OPTIC HEADLIGNT (K952289)Welch Allyn, Inc.1995-07-14
AMPHETAMINES MICRO-PLATE EIA (K935573)Solarcare Technologies Corp,Inc.1995-07-14
TE-800 PELVIC FLOOR EXERCISER (K945937)Myo/Kinetic Systems, Inc.1995-07-14
REF. 4102CV INTERMEDIARY TUBING, REF. 4509CV STERILE ZONE KIT (K951843)Future Medical Systems, Inc.1995-07-14
VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE (K945592)Vlv Associates, Inc.1995-07-14
OPIATES MICRO-PLATE ASSAY (K935565)Solarcare Technologies Corp,Inc.1995-07-14
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 (K944966)Medtronic Blood Systems, Inc.1995-07-14
GLUCOMETER ELITE M BLOOD GLUCOSE METER (K951537)Bayer Corp.1995-07-14
RADIOLOGY PACKS (K952539)Sterile Concepts, Inc.1995-07-14
CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 (K945296)Clarus Medical Systems, Inc.1995-07-14
DADE STRATUS TROPONIN-I CONTROL (K951888)Dade Intl., Inc.1995-07-13
MED-TEC TRAY ADAPTER (K950075)Medtec, Inc.1995-07-13
GLIDING NAIL (K951809)Encore Orthopedics, Inc.1995-07-13
BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES (K942087)Biopool AB1995-07-13
BIOMECHANIC LOW-PROFILE CABLE SYSTEM (K951844)Biomechanic, Inc.1995-07-13
MULTICURE(R) S GEL PAD (K950085)Multigestion (Deutschland) GmbH1995-07-13
OXBORO-MEDICAL CAUTERY TIP CLEANER (K952784)Oxboro Medical Intl., Inc.1995-07-13
CRONEX LOW ABSORPTION CASSETTE (K952891)The DU Pont Co.1995-07-13
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES (K936305)Radiometer America, Inc.1995-07-13
METALLIC RADIAL HEAD IMPLANTS (K944507)Wrightmedicaltechnologyinc1995-07-13
PARAMETERS MONITORES (K945099)Ivy Biomedical Systems, Inc.1995-07-13
FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE (K952823)Icor AB1995-07-13
STRATUS CARDIAC TROPONIN-I FLUOROMETRIC ENZYME IMMUNMNOASSAY & STRATUS CARDIAC TROPONIN-I CALIBRATORS (K951890)Dade Intl., Inc.1995-07-13
TENTATIVELY POLARUS EX ROD (K952534)Acu-Med, Inc.1995-07-13
CROSS MEDICAL - SYNERGY(TM) SPINE SYSTEM (K940631)Cross Medical Products, Inc.1995-07-13
SILON SILICONE FOAM SHEETING (K946362)Bio Med Sciences, Inc.1995-07-13
VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM (K952672)Bennett X-Ray Corp.1995-07-13
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS (K950595)Howmedica Corp.1995-07-12
DICOMIT (K951925)Dicomit Imaging Systems Corp.1995-07-12
WELLHOFER WP700 V. 3.2 (K945321)Medical Physics Instrumentation, Inc.1995-07-12
METAL FRAM WITH POLYCARBONATE LENS (K953002)Nakanishi Optical Products Corp.1995-07-12
BELTONE PERSONAL HEARING SCREENER (K943616)Beltone Electronics Corp.1995-07-12
KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT (K950962)KARL STORZ Endoscopy-America, Inc.1995-07-12
MED-TEC RADIO THERAPY TREATMENT CHAIR (K951947)Medtec, Inc.1995-07-12
A GEL WOUND DRESSING (K951862)Polymedica Industries, Inc.1995-07-12
COLLEGE OF AMER PATH (CAP) SURV VALID PROST SPEC ANTI (K942647)Scantibodies Laboratory, Inc.1995-07-12
READY NURSE SYSTEM (RNS) TRACH CARE KIT (K952925)Contour Fabricators of Florida, Inc.1995-07-12
SLIT LAMP AIA 11 (K953030)Naveen Intl., Inc.1995-07-12
CAP SAFE SYSTEM (K943057)Medical Safety Solutions1995-07-12
LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE (K942271)Level 1 Technologies, Inc.1995-07-12
DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS (K953012)Boston Surgical Products, Inc.1995-07-12
SUNGLASSES (K952890)Isohyper1995-07-12
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
MODEL 109 SERIES BLOOD PRODUCTS IRRADIATORS (K915766)J. L. Shepherd and Assoc.1995-07-12
MED-TEC TESTICULAR SEPARATOR (K951679)Medtec, Inc.1995-07-12
STERIGAUZE WET DRESSING (K952420)Acacia Laboratories, Inc.1995-07-12
SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G (K952822)Shimadzu Corp.1995-07-12
MODEL 143 SERIES BLOOD PRODUCT IRRADIATORS (K915767)J. L. Shepherd and Assoc.1995-07-12
BONE FIXATION NAIL (K943855)Acu Med, Inc.1995-07-12
DEVMED REUSEABLE TROCAR SYSTEM (K952723)Devmed Group, Inc.1995-07-11
ABELSON CRICOTHYROTOMY CANNULA (K952401)Gilbert Surgical Instruments, Inc.1995-07-11
CEDIA VITAMIN B12 (NO BOIL) ASSAY (K951134)Microgenics Corp.1995-07-11
BIO-VENT X IMPLANT (K950576)Core-Vent Corp.1995-07-11
J.B.S. CERVICAL SPINE SYSTEM (K942432)J.B.S., S.A.1995-07-11
VISUWELL SYPHILIS ANTIBODY (K932453)Biomira Diagnostics, Inc.1995-07-11
CLEAN-CUFF (K952038)Instrumed, Inc.1995-07-11
GOLD CD ULTRA MINI CANAL - MODULE (K951642)Electone, Inc.1995-07-11
MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (K942263)Zimmer, Inc.1995-07-11
SAFETY PLUS (K945843)Arent Fox1995-07-11
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) (K946150)Zimmer, Inc.1995-07-11
ABSORBABLE ACETABULAR SCREW (K946347)Zimmer, Inc.1995-07-11
CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBER (K951714)Cabot Medical Corp.1995-07-11
BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT (K951538)Syntron Bioresearch, Inc.1995-07-11
INTRODUCER (K951090)Ranfac, Corp.1995-07-11
CARIES DETECTOR (K951813)Kuraray Co.1995-07-11
PHENO-CEN GERMICIDAL DETERGENT (K951162)Central Solutions, Inc.1995-07-11
CEMENTRALIZER DISTAL STEM CENTRALIZER (K951930)Depuy, Inc.1995-07-11
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Every clearance here is in the API, with alerts when new ones post.