Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CIVCO-SUPER SCAN/BIOPSY GUIDE (K843573)CIVCO Medical Instruments Co., Inc.1984-12-13
E-COLI-CHEK TUBE (K844276)E-Y Laboratories, Inc.1984-12-13
ULTRA & ULTRA MINATURE (K843789)Qualitone1984-12-13
GENERAL UTILITY TRAY SYSTEM (K843884)Applied Medical Devices, Inc.1984-12-13
MIST-EASE NEBULIZER (K844591)General Physiotherapy, Inc.1984-12-13
DRY TRAY (K843782)E.M. Adams1984-12-13
PHILIPS SDR 1200 (K842900)Philips Medical Systems, Inc.1984-12-13
ORTHO BRAIN THROMBOPLASTIN DILUENT (K843535)Ortho Diagnostic Systems, Inc.1984-12-12
80 MG/DL GLUCOSE CONTROL (K844581)Boehringer Mannheim Corp.1984-12-12
TRI-COUNT LASER (K843485)Hematology Marketing Assoc.1984-12-12
VIS-1000 VIDEO SYSTEM (K843806)Vistek Corp.1984-12-12
GGT PROCEDURE OR GAMMA GLUTAMYL TRANSFERASE PROCED (K844720)Data Medical Associates, Inc.1984-12-12
HEMOTEC ACT I SYSTEM (K843459)Hemotec, Inc.1984-12-12
MED. DYNAMICS HIGH RESOLUTION SOLID ST (K843295)Medline Industries, Inc.1984-12-12
DIXON SCISSORS, STARINLESS STEEL, OPERATING TYPE (K844667)William Dixon Co.1984-12-12
MED. DYNAMICS SATICAN VIDEO CAMERA 5410 (K843294)Medline Industries, Inc.1984-12-12
AMS ANA CARD (K843686)Vitek Systems, Inc.1984-12-12
SHARP COLLECTION SYSTEM-SHARP-A-GATOR (K844654)Devon Industries, Inc.1984-12-12
ESCHMANN TDB50 BIPOLAR COAGULATION (K844004)Storz Instrument Co.1984-12-12
DOSIMETRIC RELEASE IN THE PROCESSING OF GAMMA STER (K844462)Washington-Greene County Branch Pennsylvania Assoc1984-12-12
C.A.S.E. CONTAINER (K844652)General Medical Co.1984-12-12
TECA MS-20 MYSTRO ELECTROPHYSIOLOGICAL (K842886)Teca, Inc.1984-12-12
UROPAPER EIKEN 8 (K843532)Syn-Kit, Inc.1984-12-12
TRIGLYCERIDE CALIBRATOR (K844468)Sigma Diagnostics, Inc.1984-12-11
CANMED 103 9300 ELECTRODE (K844097)Medtronic Vascular1984-12-11
EMIT QST ETHOSUXIMIDE ASSAY (K844204)Syva Co.1984-12-11
MULTIPLE LENS, SPECTACLES, CUSTOM (K842187)Pavuna , Ltd.1984-12-11
SIEGEN SURFACE ELECTRODES (K844646)Siegen Corp.1984-12-11
COE-LITE POLYMERIZATION UNIT (K844325)Coe Laboratories, Inc.1984-12-11
OVUSTICK SELF-TEST (K843284)Monoclonal Antibodies, Inc.1984-12-11
IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS (K844586)Instrumentation Laboratory CO1984-12-11
ULTRASONIC LITHOTRIPTOR 300A (K842024)Fibra Sonics, Inc.1984-12-11
WAKO AUTOMATED REAGENTS FOR HITACHI 705 (K842847)Wako Chemicals USA, Inc.1984-12-11
KARL STORZ 27086KC ULTRASONIC LITHOTRI (K843101)KARL STORZ Endoscopy-America, Inc.1984-12-11
MULTIPLE LENS, SPECTACLES CUSTOM (K842189)Hanmy Optical Industrial Co.1984-12-11
CHEW-DENT (K843406)Senair-Mot1984-12-11
COOPERVISION SYSTEM VI (K842945)CooperVision, Inc.1984-12-11
OMS SCISSORS (K844510)Optical Micro Systems, Inc.1984-12-11
SPECTABLE FRAME - PRODESIGN SUN CLUB (K844658)Pro Design Intl. AS1984-12-11
CORNING 614 NA/K ANALYZER (K843530)Corning Medical & Scientific1984-12-11
AMERLEX-M SPECIFIC ESTRIOL UNCONJUGATED (K844408)Amersham Corp.1984-12-11
HEARING AID - ALL IN THE EAR (K843574)Auralogics Lab1984-12-11
OPHTHALMIC CHAIR (K844362)Luneau Laboratories1984-12-11
MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE (K844553)Codman & Shurtleff, Inc.1984-12-11
DEL MAR AVIONICS 509 NEUROCORDER AMBUL (K841654)Del Mar Avionics1984-12-11
CARE 5000 CENTRAL MONITOR MS5220 ETC. (K842582)Care Monitoring Systems1984-12-11
MULTIPLE-LENS, SPECTACLES, CUSTOM (K842188)Gold Cadillac Co.1984-12-11
SPECTABLE FRAME MAGNIFYING BRILLETTE (K844657)Pro Design Intl. AS1984-12-11
PROM NAID (K843581)Lossing Orthopedic, Inc.1984-12-11
THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM (K844170)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-11
REFERRIL CALIBRATORS (K844585)Instrumentation Laboratory CO1984-12-11
AUTOTRACTION TABLE (K844233)Chattanooga Group, Inc.1984-12-11
O.M.S. GUILLOTINE CUTTER (K844374)Optical Micro Systems, Inc.1984-12-11
MEDICAL OPTICS PHACOEMULSIFICATION KIT (K844150)American Medical Optics1984-12-11
WOODLYN CLASSIC CATARACT ACUITY TEST (K843812)Woodlyn, Inc.1984-12-11
REACTIFS, IBF ULTROGELS ACA & ULTROGELS A (K844164)Lkb Instruments, Inc.1984-12-10
SANDARE ALKALINE PHOSPHATASE PROCEDURE (K844498)Sandare Chemical Co., Inc.1984-12-10
ABL300 ACID BASE LABORATORY (K844295)Radiometer America, Inc.1984-12-10
ISE REAGENTS FOR DEMAND ANALYZER (K844021)Advanced Biomedical Methods, Inc.1984-12-10
PTK HEALTHCHECK PREGNANCY TEST KIT (K844281)Healthcheck Corp.1984-12-10
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE (K844171)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10
MECHANICAL SECTOR PROBE 4 MHZ DFM (K842880)General Electric Co.1984-12-10
STERILE WATER (K843796)Paco Pharmaceutical Services, Inc.1984-12-10
COAT-A-COUNT ANDROSTENEDIONE RIA KIT (K844398)Diagnostic Products Corp.1984-12-10
ADJUST-A-TEMP MICRO (K841603)Suncoast Medical Manufacturers, Inc.1984-12-07
TOSHIBA DIGITAL CLINICAL THERMOMETER (K844124)Toshiba Medical Systems1984-12-07
FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI (K844174)Exco, Inc.1984-12-07
REPLACE-A-TIP ADJUST. LOW TEMP.- (K841459)Suncoast Medical Manufacturers, Inc.1984-12-07
TOP HYPODERMIC SYRINGE LUER LOCK (K843415)Top Surgical Manufacturers Co.1984-12-07
PERCUTANEOUS GASTROSTOMY TUBE (K842174)Mount Carmel Mercy Hospital1984-12-07
MINUTEMAN CO2 MICROSURG LASER GEN SURG (K843519)American Surgical Laser, Inc.1984-12-07
ADJUST-A-TEMP HIGH TEMPERATURE (K841604)Suncoast Medical Manufacturers, Inc.1984-12-07
MC-4000 CONSOLE & PROBES (K842959)Cryomedics, Inc.1984-12-07
MINUTEMAN C02 MICROSURG LASER PODIATRY (K843518)American Surgical Laser, Inc.1984-12-07
ACU-PATCH (K842946)Acutek1984-12-07
PAGE-WRITER INTERPRETIVE CARDIOGRAPH (K842370)Hewlett-Packard Co.1984-12-07
IV JET (K843887)Nuclear Concepts, Inc.1984-12-07
REPLACE-A-TIP ADJUSTABLE HIGH TEMP. (K841509)Suncoast Medical Manufacturers, Inc.1984-12-07
MINUTEMAN CO2 MICROSURG LASER DERMATOL- (K843517)American Surgical Laser, Inc.1984-12-07
HEPARIN INFUSIN PUMP (K843878)Armament Systems, Inc.1984-12-06
CADD-1 5100 AMBULATORY INFUSION PUMP (K843772)Deltec Systems, Inc.1984-12-06
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 (K843130)Advanced Technology Laboratories, Inc.1984-12-06
CADD-PAC 5200 AMBULATORY INFUSION PUMP (K843773)Deltec Systems, Inc.1984-12-06
FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY (K844105)Bartels Immunodiagnostic Supplies, Inc.1984-12-06
FOCUSCOPE UNIVERSAL SYSTEM (K843900)Medical Diagnostics, Ca.1984-12-06
ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) (K844141)Lmd Laboratories1984-12-06
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8 (K843129)Advanced Technology Laboratories, Inc.1984-12-06
KETAC-SILVER (K843566)Espe GmbH (Us)1984-12-06
COLOSCREEN SELF-TEST (K843352)Helena Laboratories1984-12-05
PHARMA-PLAST URIDROP-URIDOME (K843478)Zimmar Consulting , Ltd.1984-12-05
INTRAVENOUS START KIT (K843813)Pro-Lab, Inc.1984-12-05
OPHTHALMIC STAND (K844363)Luneau Laboratories1984-12-05
PMS DRAPE PACK (K844465)Professional Medical Services1984-12-05
PHARMA-PLAST RECTAL TIP (K843477)Zimmar Consulting , Ltd.1984-12-05
PERCUTANEOUS NEPHROSTOMY TROCAR SYS (K844090)American Edwards Laboratories1984-12-05
BIOSEARCH GLASER PEG PERCUTANEOUS ENDOSCOPIC GASTR (K844222)Biosearch Medical Products, Inc.1984-12-05
QUANTUM 412 (K844570)Keta Corp.1984-12-05
COULTER COUNTER MODEL M4 (K843303)Coulter Electronics, Inc.1984-12-05
DYNASCOPE MONITOR DS-800 (K844348)Fukuda Denshi USA, Inc.1984-12-04
DRESSING CHANGE TRAY STERILE 5002 (K842404)Pro-Lab, Inc.1984-12-04
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Track 1984 automatically

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