Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
ALLEGRO (TM) FERRITIN IMMUNOASSAY SYSTEM (K874572)Nichols Institute Diagnostics1987-12-02
CAPTAIN POWER SUNGLASSES STYLES: #1020 #1021 (K873983)Arcotoys, Inc.1987-12-02
TECNOL FLUID SHIELD SURGICAL MASK (K874608)Tecnol New Jersey Wound Care, Inc.1987-12-02
ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE (K874585)Angiomed U.S., Inc.1987-12-02
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS (K873857)Dow Corning Wright1987-12-01
ABBOTT PAP-EIA (K873903)Abbott Laboratories1987-12-01
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE (K871517)Olympus Corp.1987-11-30
GAIT-AID ORTHOPEDIC INSOLE (K874502)Gait-Aid, Inc.1987-11-30
OLYMPUS LUS ULTRASONIC LITHOTRIPTER (K873367)Olympus Corp.1987-11-30
LIFECARE EXHALATION VALVE #06-699 (K873570)Lifecare Services, Inc.1987-11-30
ROTASCREEN EIA (K873740)Mercia Diagnostics , Ltd.1987-11-27
LAD MODEL 735 LUMINOMETER (K874262)Los Alamos Diagnostics1987-11-27
DYNAMARK 1000 (K873979)Dynamedics, Inc.1987-11-27
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER (K873438)C.R. Bard, Inc.1987-11-27
REUMA TEST (K873782)Sclavo, Inc.1987-11-27
REFLEX(TM) CA-T CLIP APPLIER (K873309)Richard-Allan Medical Ind., Inc.1987-11-27
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT (K872948)Uresil Corp.1987-11-27
TELEPHONE DEFIBRILLATOR SYSTEM (K864257)Medphone Corp.1987-11-27
CONCEPT SUTURE NEEDLE (K874515)Concept, Inc.1987-11-27
CLOSED FOLEY CATHETER SYSTEM (K873288)Todd Medical, Inc.1987-11-27
SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER (K873760)Coherent Medical Group1987-11-27
ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY (K873080)Andronic Devices, Ltd.1987-11-25
MULTICHEM (R) TOTAL BILIRUBIN (K874311)Simmler, Inc.1987-11-25
BIOSURE SPECIMEN COLLECTION CONTAINER (K873593)Biosure, Inc.1987-11-25
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER (K873734)Toa Medical Electronics USA, Inc.1987-11-25
IQ/QCA TOTAL BILIRUBIN (K874261)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-11-25
TISSUE CULTURE FLASKS (K873890)Nunc, Inc.1987-11-25
IGE ENZYME IMMUNOASSAY TEST KIT NO. MB-1064 (K874406)Medix Biotech, Inc.1987-11-25
CIC-RAJI CELL REPLACEMENT ENZYME IMMUNOASSAY (K874379)Cytotech, Inc.1987-11-25
MYCO-FLUOR REAGENT A & B (K874662)Scott Laboratories, Inc.1987-11-25
VIDEO ARTHROSCOPE, 1.7MM X 55 MM (K873387)Arthropedics, Inc.1987-11-25
CREAT BRAND O-RISE GENERAL ASPIRATOR (K873940)Aesthetech Corp.1987-11-25
LIVE OAK ALLERGEN DISC (K874440)Incstar Corp.1987-11-25
FIAX TEST KIT FOR ENA (RNP/SM) ANTIBODIES (K873708)Whittaker Bioproducts, Inc.1987-11-25
TISSUE CULTURE DISHES (K873891)Nunc, Inc.1987-11-25
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS (K874364)Bausch & Lomb, Inc.1987-11-25
EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 (K874476)Em Diagnostic Systems, Inc.1987-11-25
CANNULA AND GENERAL PURPOSE ASPIRATOR (K873552)Cosmedtech, Inc.1987-11-25
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 (K874031)Diagnostic Products Corp.1987-11-25
ARTHROBOT 100 UPPER LIMB POSITIONER (K873079)Andronic Devices, Ltd.1987-11-25
TISSUE CULTURE TUBES (K873889)Nunc, Inc.1987-11-25
O.P.T.(TM) OVULATION PREDICTION TEST (K870584)Warner-Lambert Co.1987-11-25
BAXA EXACTA-MED PHARMACY PUMP (K873875)Baxa Corp., Sub. of Cook Group, Inc.1987-11-24
TODD MEDICAL/SKILLED CARE PRODUCTS (K873499)Todd Medical, Inc.1987-11-24
EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 (K874397)Em Diagnostic Systems, Inc.1987-11-24
TITAN GEL REP LDH-30 HV (K874142)Helena Laboratories1987-11-24
ELEC-TIP (K873298)Etymotic Research1987-11-24
NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY (K873737)Cambridge Medical Technology1987-11-24
CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT (K874456)Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd.1987-11-24
BRACHIAL PLEXUS CATHETER - BP-01200 (K874105)Arrow Intl., Inc.1987-11-24
IRAS GLARE TESTER (K873987)Randwal Instrument Co., Inc.1987-11-24
GLUCOSE-HK REAGENT (K873835)Intersect Systems, Inc.1987-11-24
TITAN GEL REP LDH-6 HV (K874145)Helena Laboratories1987-11-24
HUMID-VENT(R) 2 PORT (K873768)Gibeck Respiration1987-11-24
ESOPHAGEAL STETHOSCOPE W/ELECTRICAL CONDUCTORS (K874295)Sheridan Catheter Corp.1987-11-24
ACE SELFTAPPING CANCELLOUS BONE SCREW (K874593)Ace Medical Co.1987-11-24
EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY (K874578)Syva Co.1987-11-24
HOT WHEELS (K873895)Everest & Jennings, Inc.1987-11-24
INFLATABLE FULL LEG SPLINT (K874051)Vinyl Technology, Inc.1987-11-23
PATIENT TEMPERATURE MONITOR, MODEL 1000 (K874159)Sonodyne America, Ltd.1987-11-23
IRON HORSE ONE (K874246)Iron Horse Productions, Inc.1987-11-23
ADJUSTABLE WRENCHES (K874359)Med-Tool, Inc.1987-11-23
ACU-MICRO-NEEDLE (K874024)Acuderm, Inc.1987-11-23
REVISED LABELING FOR TDX COCAINE METABOLITE (K874487)Abbott Laboratories1987-11-23
INFLATABLE FOOT & ANKLE SPLINT (K874050)Vinyl Technology, Inc.1987-11-23
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM (K873680)Oxford Medilog, Inc.1987-11-23
A-GENT LIQUID AMYLASE (K873944)Abbott Laboratories1987-11-23
REVISED LABELING FOR TDX BENZODIAZEPINES (K874489)Abbott Laboratories1987-11-23
VITALOG PMS-8 (MODIFICATION) (K871813)Vitalog Corp.1987-11-23
REVISED LABELING FOR TDX PHENCYCLIDINE (K874484)Abbott Laboratories1987-11-23
MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH (K871993)Cambridge Medical Instruments, Inc.1987-11-23
OVUGEN SURETEST (K873534)Biogenex Laboratories1987-11-23
ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS (K874163)Catachem, Inc.1987-11-23
DYNATRAC (K872974)Med*Ex Diagnostics of Canada, Inc.1987-11-23
CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/ (K871928)Medline Industries, Inc.1987-11-23
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 (K873788)Pacific Biotech, Inc.1987-11-23
VISION CARE/PHAKOSYSTEMS ECHORULE (K871938)Phakosystems, Inc.1987-11-23
INFLATABLE HALF LEG SPLINT (K874052)Vinyl Technology, Inc.1987-11-23
ZOLL NTP-1200 PACER/DEFIBRILLATOR (K873402)Zmi Corp.1987-11-23
STAND AID (K872934)Stand Aid of Iowa, Inc.1987-11-23
EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 (K874477)Em Diagnostic Systems, Inc.1987-11-23
PIN PUNCH (K874356)Med-Tool, Inc.1987-11-23
VENTRESCREEN, HCG URINE (K874258)Ventrex Laboratories, Inc.1987-11-23
PARAMAX URIC ACID REAGENT (K873456)Baxter Healthcare Corp1987-11-23
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. (K874394)Intermedics, Inc.1987-11-23
COLOR FLOW IMAGING (K873096)Advanced Technology Laboratories, Inc.1987-11-23
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) (K874299)Incstar Corp.1987-11-23
PARAMAX CREATININE REAGENT (K873531)Baxter Healthcare Corp1987-11-23
COMBINATION WRENCHES (K874358)Med-Tool, Inc.1987-11-23
ECG ELECTRODE SYSTEM (K873442)Hiltrode, Inc.(A/S) Subsidiary Munkenes A/S1987-11-23
INFLATABLE FULL ARM SPLINT (K874053)Vinyl Technology, Inc.1987-11-23
REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA. (K874486)Abbott Laboratories1987-11-23
APLICARE STERILE WATER - FOR SUCTION CATHETER ONLY (K873563)Aplicare, Inc.1987-11-23
KAMBIN LAMINECTOMY FRAME (K874494)Avec Scientific Design Corp.1987-11-23
CIBA CORNING MAGIC LITE T3 IMMUNOASSAY (K873945)Ciba Corning Diagnostics Corp.1987-11-23
PROTEIN STANDARD CALIBRATOR (K871755)Wako Chemicals USA, Inc.1987-11-23
360D DC DEFIBRILLATOR (K874091)Medac, Inc.1987-11-23
PARAMAX UREA NITROGEN REAGENT (K873532)Baxter Healthcare Corp1987-11-23
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (K874155)Circadian, Inc.1987-11-23
TITAN GEL REP LDH-12 HV (K874143)Helena Laboratories1987-11-23
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Track 1987 automatically

Every clearance here is in the API, with alerts when new ones post.