Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SURGI-PAP KIT (K850676)Surgipath Medical Industries, Inc.1985-03-22
CUE FERTILITY MONITOR (K850579)Zetek, Inc.1985-03-22
DNASE TEST MEDIA, CHRISTENSEN'S UREA AGAR (K850719)Rapid City Regional Hospital, Inc.1985-03-22
CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER (K850384)Cardiac Control Systems, Inc.1985-03-21
ACTH II BY RADIOIMMUNOASSAY (K850882)Immuno Nuclear Corp.1985-03-21
BIOSAMPLER (K844615)Biotek-Caribbean1985-03-21
KM PRODUCTS ASPIRATING TUBING (K850105)Km Products1985-03-21
IN-TH-EAR HEARING AID (K850123)General Hearing Instruments, Inc.1985-03-21
ACUFEX ARTHROSCOPIC SHAVER (K844130)Acufex Microsurgical, Inc.1985-03-21
CHLAMYDIA FLUORO-KIT 1680 (K850158)Clinical Sciences, Inc.1985-03-21
BASIS DIGITAL THERMOMETER MODEL BTM-1 (K844624)Terayco Intl., Ltd.1985-03-21
TITERTEK MULTISKAN MSS/340 (K844419)Flow Laboratories, Inc.1985-03-21
ENCORE FERRITIN REAGENT (K850680)Hybritech, Inc.1985-03-21
ARGYLE 15MM SWIVEL CONNECTOR (K850625)Sherwood Medical Co.1985-03-21
OPHTHALMIC DROPPER BOTTLES (K850962)Acacia, Inc.1985-03-21
ELECTRIC LIFT TABLE-OPHTHALMIC (K851008)Turbine Support Systems, Inc.1985-03-21
PAD, PRE-OPERATIVE PREPARATION (K850811)East Texas Lighthouse For the Blind1985-03-21
TITERTEK MULTISKAN MCC (K844418)Flow Laboratories, Inc.1985-03-21
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS (K845032)Pharmacia, Inc.1985-03-21
NASOPHARYNGEAL AIRWAY-ROBERTAZZI (K850644)Dryden Corp.1985-03-21
DART DAILY AIR REMOVAL TEST (K844512)American Sterilizer Co.1985-03-21
TITERTEK TWINREADER 78-630-00 (K844567)Flow Laboratories, Inc.1985-03-21
ISIS (K844736)Oxford Medilog, Inc.1985-03-21
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030 (K850488)Strato Medical Corp.1985-03-21
ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEM (K850533)Atlantic Optical Systems, Inc.1985-03-21
CUSTOM STERILE PROCEDURE KITS (K842356)Sterile Design, Inc.1985-03-21
CORNEASCOPE MODEL 1200 (K850665)Kera Corp.1985-03-20
SALT BROTH (K850846)Micro Media Laboratories1985-03-20
SELECTIVE CULTURE MEDIUM (K850736)Roseville Medical Laboratoriesu1985-03-20
AMDINOCILLIN 10 MCG SENSI-DISC (K850357)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-03-20
CELL CULTURE REFEED MEDIUM (K850537)Hillcrest Biologicals1985-03-20
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE (K850658)Oxoid U.S.A., Inc.1985-03-20
MUELLER HINTON CHOCOLATE AGAR (K850843)Micro Media Laboratories1985-03-20
C.N.V.T. (K850299)Pro-Lab, Inc.1985-03-20
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG (K850307)Pro-Lab, Inc.1985-03-20
CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING (K850731)Roseville Medical Laboratoriesu1985-03-20
MUCOLYSE (K850300)Pro-Lab, Inc.1985-03-20
CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (K850732)Roseville Medical Laboratoriesu1985-03-20
C.L.A.T. (K850308)Pro-Lab, Inc.1985-03-20
BUN (RATE) REAGENT (K850923)Sigma Diagnostics, Inc.1985-03-20
FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G (K850127)Computer Dialysis Systems, Inc.1985-03-20
VISOPROTECT: OCCULAR SHIELD (K850099)Rockway Enterprises, Inc.1985-03-20
TRANSPORT CULTURE MEDIUM (K850737)Roseville Medical Laboratoriesu1985-03-20
CEFTRIAXONE 30 MCG SENSI-DISC (K850358)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-03-20
CAMPYLOBACTER SUPPLEMENT -SKIRROW (K850306)Pro-Lab, Inc.1985-03-20
DIFFERENTIAL CULTURE MEDIUM (K850734)Roseville Medical Laboratoriesu1985-03-20
EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY (K850712)Syva Co.1985-03-20
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11 (K850883)Storz Instrument Co.1985-03-20
BRAIN HEART INFUSION AGAR (K850848)Micro Media Laboratories1985-03-20
AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (K850756)Travenol Laboratories, S.A.1985-03-20
CR-39 TYPE RESIN (K850905)Orplex Corp.1985-03-20
CORN MEAL AGAR (K850718)Rapid City Regional Hospital, Inc.1985-03-20
V AGAR (K850844)Micro Media Laboratories1985-03-20
MOD THAYER MARTIN MARTIN LEWIS (K850841)Micro Media Laboratories1985-03-20
YEAST DIALYSATE (K850301)Pro-Lab, Inc.1985-03-20
SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E (K850636)Fisher Scientific Co., LLC1985-03-20
MULTIPURPOSE CULTURE MEDIUM (K850733)Roseville Medical Laboratoriesu1985-03-20
BRAIN HEART INFUSION BROTH (K850842)Micro Media Laboratories1985-03-20
THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN (K850847)Micro Media Laboratories1985-03-20
0.85% SALINE (K850845)Micro Media Laboratories1985-03-20
SUPPLEMENT FOR CULTURE MEDIUM (K850738)Roseville Medical Laboratoriesu1985-03-20
AMDINOCILLIN 10 MCG SENSITIVITY DISCS (K850607)Difco Laboratories, Inc.1985-03-20
VISOPROTECT OCCULAR SHIELD (K850005)M.S.G. Health Systems, Inc.1985-03-20
DATA ZYME ACID PHOSPHATASE PROCEDURE (K850902)Data Medical Associates, Inc.1985-03-20
ABBOTT INPERSOL CYCLER 1000 (K845042)Abbott Laboratories1985-03-19
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & (K844955)Miles Laboratories, Inc.1985-03-19
GLUTAMYLTRANSFERASE ASSAY KIT (K850788)Diagnostic Chemicals, Ltd. (Usa)1985-03-19
ACCULEVEL THEOPHYLLINE TEST (K844642)Syva Co.1985-03-19
IVAC KEOFEED II POLYURETHANE FEEDING TUBE (K850182)Y1985-03-19
SERALYZER ARIS PHENYTOIN REAGENT STRIPS (K842092)Miles Laboratories, Inc.1985-03-19
CLOSED WOUND DRAIN (K850037)Consolidated Medical Equipment, Inc.1985-03-19
HEPATIC PARENCHYMAL SUCTION DISSECTOR (K850288)Beecher Medical Diagnostic Instrumentation1985-03-18
MENSINK-GOOSEN CATHETER (K844889)Goosen Enterprises, Inc.1985-03-18
PERIMETER YANKAUER SUCTION TIPS & SETS (K844924)Perimeter Medical, Inc.1985-03-18
PERIMETER THORACIC CATHETER (K844922)Perimeter Medical, Inc.1985-03-18
MULTIPLE OUTLET MANIFOLD (K850389)The Anspach Effort, Inc.1985-03-18
IRRIGA SUC ILLUM ISIS 710 & 7100 SERIES (K844973)Vital Metrics, Inc.1985-03-18
PERIMETER MEDIASTINAL DRAIN (K844925)Perimeter Medical, Inc.1985-03-18
WEILL CEMENTLESS THREADED ACETABULAR CUP (K844943)Advanced Biosearch Assn.1985-03-18
OIL, MINERAL (K844378)Treace Medical, Inc.1985-03-18
PERIMETER SUMP DRAIN (K844923)Perimeter Medical, Inc.1985-03-18
PERIMETER CLOSED WOUND RESEVOIR (K844921)Perimeter Medical, Inc.1985-03-18
PREFORMED DENTAL IMPRESSION TRAYS (K850776)L.A.K. Ent., Inc.1985-03-18
SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL (K850699)Williams Gold Refining Co., Inc.1985-03-18
SILICONE (K844377)Treace Medical, Inc.1985-03-18
FOREMOST DENTIN ADHESIVE (K845033)Foremost Dental Mfg., Inc.1985-03-18
FOREMOST LITE CURE PIT & FISSURE SEALANT (K845034)Foremost Dental Mfg., Inc.1985-03-18
CAULK DYCAL LIGHT CURED (K850641)Dentsply Intl.1985-03-18
ENRICHED CULTURE MEDIUM (K850735)Roseville Medical Laboratoriesu1985-03-16
CUSTOM OPEN HEART TRAY (K850072)Pro-Lab, Inc.1985-03-15
CONCEPT SUCTION SLEEVE (K850423)Concept, Inc.1985-03-14
AUTOFLUOR V SYSTEM (K842991)Tech America Diagnostics1985-03-14
AMYLASE PRODUCTS (K850798)Data Medical Associates, Inc.1985-03-14
ARTHROSCOPY SUCTION BIOPSY PUNCH (K850527)T. Korossurgical Instruments Corp.1985-03-14
SPECTRONIC 2000 SPECTROPHOTOMETER (K850767)Bausch & Lomb, Inc.1985-03-14
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN (K850587)Applications Lab1985-03-14
LIQUA-SONIC GEL (K841871)Chester Labs, Inc.1985-03-14
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS (K850334)Roche Diagnostic Systems, Inc.1985-03-14
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M (K850586)Applications Lab1985-03-14
VAS-CATH PARALLEL DUAL LUMAN JUGULAR CANNUAL CATH (K844336)Vas-Cath of Canada , Ltd.1985-03-13
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Every clearance here is in the API, with alerts when new ones post.