Atlas FDA

1984

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

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RecordFirmDate
TOTAL IRON UIBC/TIBC ASSAY (K840485)Somas Medical Industries, Inc.1984-03-12
SCAVENGER TUBING 19MM (K840849)The Kendal Co.1984-03-12
KPE PLUS-PAK SURGICAL SYSTEM (K833962)Ipax, Inc.1984-03-12
DOWNING SPECTRAL ILLUMINATOR (K833446)Vision Health Technology1984-03-12
ORTHO BACTERIURIA DETECTION SYS (K833834)Ortho Diagnostic Systems, Inc.1984-03-12
CHYMOFAST TEST (K833418)Allergenetics1984-03-12
LIGACLIP METALLIC LIGATING CLIP (K834267)ETHICON, Inc.1984-03-12
SENSIBEAD EIA DIGOXIN KIT (K840673)Terumo Medical Corp.1984-03-12
STEIGER TUNNELING INSTRUMENT 285 (K840529)Evermed, Inc.1984-03-12
CAT 13-CLINICAL CHEMISTRY DEVICES (K840317)Imm Enterprises , Ltd.1984-03-12
MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE (K840354)Sherwood Medical Co.1984-03-12
FORMALIN SOLUTION 10% NEUTRAL BUFFER (K840926)Sigma Chemical Co.1984-03-12
MATERIAL ADDITION LEXAN & K-RESIN (K833554)Procedure Products, Inc.1984-03-12
LAERDAL SUCTION UNIT (K840110)Laerdal Medical Corp.1984-03-12
VASCULAR RECORDER #301 (K832369)Imex Medical Systems, Inc.1984-03-12
IMPLANTABLE ENDOCARDIAL PACING LEADS (K831926)Oscor, Inc.1984-03-12
MOLE-MARKER (K840651)Notation Systems, Inc.1984-03-12
BIOPSY NEEDLES VARIOUS (K840401)E-Z-Em, Inc.1984-03-12
SURGISCRIBE MARKING PEN (K840470)Surgicot, Inc.1984-03-12
NEEDLE BENDER TX8225 (K834108)Today'S Machining & Design, Inc.1984-03-12
WESTERMAN-JENSEN BIOPSY NEEDLE (K840168)Popper & Sons, Inc.1984-03-12
PLT - 4 PLATELET (K840302)R&D Systems, Inc.1984-03-12
AMYLOID STAIN, CONGO RED HT 60 (K840798)Sigma Chemical Co.1984-03-12
CATEGORY 2 GEN. HOSPITAL & PERSONAL USE (K840306)Imm Enterprises , Ltd.1984-03-12
PBC SCALP VEIN SET (K834255)Philadelphia Biologics Center1984-03-12
CAT 11- GENERAL & PLASTIC SURGERY DEV (K840315)Imm Enterprises , Ltd.1984-03-12
CAT. 16-IMMUNOLOGY DEVICES (K840320)Imm Enterprises , Ltd.1984-03-12
MILLEREISEN CURVED BIOPSY NEEDLE (K840157)Preventive Medicine Institute1984-03-12
RIGHT CORONARY GUIDING CATHETER (K833801)Advanced Cardiovascular Systems, Inc.1984-03-12
ULNAR NERVE PROTECTOR (K840421)Devon Industries, Inc.1984-03-12
TISSUE EXPANDER (K840464)Surgitek1984-03-12
CAT 12-ORTHOPEDIC & REHAB DEVICE (K840316)Imm Enterprises , Ltd.1984-03-12
CAT. 3 GASTROENTEROLOGY-UROLOGY DEV (K840307)Imm Enterprises , Ltd.1984-03-12
T-METER (K840487)K.J. Electronics1984-03-12
PACING ELECTRODE (K834431)Pacesetter Systems1984-03-12
CARDIAC CATHETERIZATION PACK (K840671)Professional Medical Services1984-03-12
CAT. 5-RADIOLOGY DEVICES (K840309)Imm Enterprises , Ltd.1984-03-12
TRACHEOSTOMY CLEANING TRAY (K840664)American Pharmaseal Div. Ahsc1984-03-12
VENA * BRIDGE (K840403)Neward Enterprises, Inc.1984-03-12
FASCIA CUTTER (K834514)Stryker Corp.1984-03-12
POIRIER COMMODES (K840639)Poirier S.A.1984-03-09
AMS GRAM-POSITIVE IDENT. CARD (K834389)Vitek Systems, Inc.1984-03-09
ACID FAST BACILLI STAIN CONTROL (K840515)Scientific Device Laboratory, Inc.1984-03-09
APSARA ANALYZER (K834534)Datachem, Inc.1984-03-09
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY (K840539)Shiley, Inc.1984-03-09
PROTOZOA STAIN CONTROL (K840517)Scientific Device Laboratory, Inc.1984-03-09
ORION BIOFEEDBACK DATA ACQUISITION (K840223)Self Regulation Systems, Inc.1984-03-09
ALLERCOAT MULTISCREEN DISCS (K840360)Kallestad Laboratories, Inc.1984-03-09
AUTOGROUPER 16C SYS AUTOMATED REAG (K834149)Technicon Instruments Corp.1984-03-09
LIQUI ZYME TOTAL BILIRUBIN REAGENT (K840564)American Research Products Co.1984-03-09
SDI PREPAX DILUKIT 29-1000 (K840044)Scientific Distributors, Inc.1984-03-09
METACHROMATIC GRANULE STAIN CONTROL (K840516)Scientific Device Laboratory, Inc.1984-03-09
OMEGA 5000 (K833978)Invivo Research Labs, Inc.1984-03-09
PARAMAX ALANINE AMINOTRANSFERASE (K840705)American Dade1984-03-09
TRI-TUBE RIA (K840589)Nuclear Medical Laboratories, Inc.1984-03-09
AMS GRAM-NEGATIVE IDENT. CARD (K834269)Vitek Systems, Inc.1984-03-09
TRI-COUNT 10 (K834371)Hematology Marketing Assoc.1984-03-09
DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (K840404)Tago, Inc.1984-03-09
LEECO E2 QUANT DIAG. TEST KIT (K834586)Leeco Diagnostics, Inc.1984-03-09
STRATUS THYROID UPTAKE FLUOROMETRIC (K834209)American Dade1984-03-09
AVL MODEL 945 BLOOD GAS SYSTEM (K834601)Avl Scientific Corp.1984-03-09
YERSINIA SUPPLEMENT (K840615)Remel Co.1984-03-09
ANTHROSCOPY SYSTEM (K834146)Cabot Medical Corp.1984-03-08
FOLEY CATHETERIZATION TRAY-VARIOUS (K832363)Inmed Corp.1984-03-07
PHONATORY FUNCTION ANALYZER PS-77 (K832678)Kells Medical, Inc.1984-03-07
NO POUR BASIN (K840988)Concord Laboratories, Inc.1984-03-07
JAKOBI SURG. INSTRUMENTS #8 15 (K834190)Imm Enterprises , Ltd.1984-03-06
JAKOBI SURG. INSTRUMENTS #7 10/43 (K834188)Imm Enterprises , Ltd.1984-03-06
PISTON SYRINGE DISPOS. STERILE SYRING (K840192)Interexpo Corp.1984-03-06
OP-CON SURG. INSTRUMENT #7 (K834172)Imm Enterprises , Ltd.1984-03-06
PORT-A-CATH IMPLANTABLE CATHETER SYS (K832906)Pharmacia, Inc.1984-03-06
LOPEZ LOCK (K840273)Icu Medical, Inc.1984-03-06
SURGICAL SUCTION INSTRUMENT-REUSABLE (K840007)Lawton Surgical Instruments1984-03-06
INTRADISCAL THERAPY TRAY (K834553)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-03-06
HYPODERMIC SYRINGES & NEEDLES (K834548)Cordis Corp.1984-03-06
OP-CON SURGICAL INSTRUMENT #9 (K834540)Imm Enterprises , Ltd.1984-03-06
CONCENTRATED PLATELET ADMIN. SET (K840212)American Mcgaw1984-03-06
LASER MIRROR (K840982)American V. Mueller1984-03-06
FPP IV SECURE (K840683)Fpp, Inc.1984-03-06
JAKOBI SURG. INSTRUMENTS #7 44/47 (K834189)Imm Enterprises , Ltd.1984-03-06
CRYSTALLINE BONE SCREW ENDO-OSSEOUS (K834364)C.B.S. Biotechnics, Inc.1984-03-06
SHOFU PORCELAIN STAIN (K834497)Shofu Dental Corp.1984-03-06
SILCATH (K834091)Hdc Corp.1984-03-06
PAB IV CONTAINER (K840388)American Mcgaw1984-03-06
MESULIN INSULIN INFUSION SET (K833398)Molnlycke A/S Hospital Products1984-03-06
MEDI-JECTOR II (K834044)Derata Corp.1984-03-06
HH SUBCUTANEOUS ACCESS PORT (K833672)Holter-Hausner Intl.1984-03-06
STRATUS TOTAL THYROXINE FLUOROMETRIC (K834210)American Dade1984-03-05
APPOSE ULE STERILE DISPOS. SKIN STAP (K840177)Davis & Geck, Inc.1984-03-05
WILCOR-XR RP MEDICAL FILM (K834613)Cea America Corp.1984-03-05
CEMENT RESTRICTOR (K840413)American Ortomed Corp.1984-03-05
DOWING OPHTHALMIC CHAIR AC-POWERED (K833539)Vision Health Technology1984-03-05
SUTURE-AID BOOTIES (K832441)Omega-Med Intl., Inc.1984-03-05
ABSORBENT INCONTINENT PADS & BRIEFS (K834359)Weyerhaeuser Co.1984-03-05
AQUA TRAP (K834573)Airlife, Inc.1984-03-05
BOUNDARY REINFORCED SINGLE-USE GOWNS (K834339)Procter & Gamble Mfg. Co.1984-03-05
INFA COMPLETE BREAST PUMP & MILK STORAG (K840325)Monterey Laboratories, Inc.1984-03-05
UNITIZED HEMATOLOGY SET 65132/93 (K840477)Emd Chemicals, Inc.1984-03-05
SKIN STAPLE REMOVER (K840089)Mediquest, Inc.1984-03-05
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (K840308)Imm Enterprises , Ltd.1984-03-05
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