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32,815 FDA 510(k) clearances · Device class

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RecordFirmDate
ADVANTAGE (K840120)Gilford1984-03-23
PRESERV TRANSPORT & CULTURE PACK (K840968)Preventive Diagnostics Corp.1984-03-23
CLOSTRIDIUM DIFFICILE AGAR DEEP & (K840889)Remel Co.1984-03-23
ORTHO BI-LEVEL RECEPTOR CONTROL (K834064)Ortho Diagnostic Systems, Inc.1984-03-23
PRESERV CARY BLAIR TRANSPORT PACK (K840990)Preventive Diagnostics Corp.1984-03-23
STREPTOCOCCUS GR. B CONTROL (K840513)Scientific Device Laboratory, Inc.1984-03-23
PBS W/MG+2 & CA+2 (K834136)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
MCCOY CELLS (K834119)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
VERO CELLS (K834124)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (K834191)Imm Enterprises , Ltd.1984-03-22
DISPOSABLE CUVETTE ARRAY (K840231)Consumable Lab Supplies1984-03-22
SERENITY CONTOURED ABSORBENT SHIELDS (K840679)Johnson & Johnson Consumer Products, Inc.1984-03-22
DIGITAL PROCESSING SYSTEM (K840052)Adac Laboratories1984-03-22
MRC-5 CELLS (K834126)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
LLC-MK2-RHESUS MONKEY KIDNEY CELLS (K834120)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
WI-38 HUMAN LUNG CELLS (K834123)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
JAKOBI SURG. INSTRUMENTS #3 21/22/24 (K834192)Imm Enterprises , Ltd.1984-03-22
SPEECH TEACHER (K840112)Joseph A. Resnick1984-03-22
EKTACHEM CLINICAL CHEM. SLIDES (K840151)Eastman Kodak Company1984-03-22
HUMAN FIBROBLASTIC CELLS-HUMAN NEWBORN (K834117)Bartels Immunodiagnostic Supplies, Inc.1984-03-22
PROBES, VARIOUS (K841003)Premier Dental Products Co.1984-03-20
SANI CATCH BA (K833814)Concord Laboratories, Inc.1984-03-19
MELOLITE (K833954)Smith & Nephew, Inc.1984-03-19
DEMAND OXYGEN CONTROLLER (K833351)Healthdyne, Inc.1984-03-19
ANESTHESIA VENTILATOR CIRCUIT (K840850)The Kendal Co.1984-03-19
OPHTEC RUST RING REMOVER (K834354)Jedmed Instrument Co.1984-03-19
ACCUFLEX (K834590)Micromedic Systems1984-03-19
LH QUIK RIA KIT (K840174)Pacific Biotech, Inc.1984-03-19
PHOSPHORUS REAGENT SYSTEM (K840215)Sclavo, Inc.1984-03-19
ACUFEX DREZ COMMUNICATING DRILL GUIDE (K834350)Acufex Microsurgical, Inc.1984-03-19
BERNIER ARM SUPPORT (K840653)T.C. Toll Corp.1984-03-19
PORTABLE TRANSIT CHAIR (K840638)Poirier S.A.1984-03-16
CEHPALOMETRIC HEAD POSITIONER (K840275)Gary E. Hall, Dds1984-03-16
POSTERIOR CAPSULOTOMY CYSTITOME (K840660)Sharpoint, Inc.1984-03-16
SURGICAL KNIFE (K834546)Fine-Cut Diamond Instruments1984-03-16
NEONATE MASK FOR BABIES (K840444)Richards Medical Co., Inc.1984-03-16
INLINE FOAM NOSE (K840398)Mallinckrodt Critical Care1984-03-16
EYE SURGERY INSTRUMENT (K840101)Truline Instruments, Inc.1984-03-16
ERGO DIAGNOSTIC CARD (K834145)American Ergo Systems1984-03-16
FOAM NOSE (K840399)Mallinckrodt Critical Care1984-03-16
ANTERIOR CAPSULECTOMY CYSTITOME (K840659)Sharpoint, Inc.1984-03-16
CORNING 4000 MULTI-WELL GAMMA COUNTER (K834508)Corning Medical & Scientific1984-03-16
OXYGEN TUBING (K840897)Medical Technologies of Georgia1984-03-16
ENDO-SECURE (K840844)Exidyne, Inc.1984-03-16
STERILIZED DISPOS. CYSTOTOME (K840442)Microsurgical Technology, Inc.1984-03-16
POWERMAT VRP-1 X-RAY IMAGING (K840698)Powers Chemco, Inc.1984-03-16
CATEGORY 6 OPTHALMIC DEVICES (K840310)Imm Enterprises , Ltd.1984-03-16
MICRO FORCEPS (K834355)Jedmed Instrument Co.1984-03-16
ROTAVIRUS BIO-ENZABEAD SCREEN KIT (K834443)Litton Bionetics1984-03-16
TITAN GEL LIPOPROTEIN ELECTROPHORESIS (K833611)Helena Laboratories1984-03-15
OPERATING ROOM TRAY SET (K840021)Medi-Plast Intl., Inc.1984-03-15
HYPAFIX DRESSING RETENTION SHEET (K833916)Smith & Nephew, Inc.1984-03-12
DEVON HEAD REST (K840422)Devon Industries, Inc.1984-03-12
CAT 15-HEMATOLOGY & PATHOLOGY DEVICE (K840319)Imm Enterprises , Ltd.1984-03-12
DISPOSIQUET A DISPOS. TOURNIQUET (K840489)Med Lab Products1984-03-12
TOTAL IRON UIBC/TIBC ASSAY (K840485)Somas Medical Industries, Inc.1984-03-12
ORTHO BACTERIURIA DETECTION SYS (K833834)Ortho Diagnostic Systems, Inc.1984-03-12
CAT 13-CLINICAL CHEMISTRY DEVICES (K840317)Imm Enterprises , Ltd.1984-03-12
FORMALIN SOLUTION 10% NEUTRAL BUFFER (K840926)Sigma Chemical Co.1984-03-12
IMPLANTABLE ENDOCARDIAL PACING LEADS (K831926)Oscor, Inc.1984-03-12
MOLE-MARKER (K840651)Notation Systems, 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
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
CAT 11- GENERAL & PLASTIC SURGERY DEV (K840315)Imm Enterprises , Ltd.1984-03-12
CAT. 16-IMMUNOLOGY DEVICES (K840320)Imm Enterprises , Ltd.1984-03-12
ULNAR NERVE PROTECTOR (K840421)Devon Industries, Inc.1984-03-12
CAT 12-ORTHOPEDIC & REHAB DEVICE (K840316)Imm Enterprises , Ltd.1984-03-12
CAT. 3 GASTROENTEROLOGY-UROLOGY DEV (K840307)Imm Enterprises , Ltd.1984-03-12
CAT. 5-RADIOLOGY DEVICES (K840309)Imm Enterprises , Ltd.1984-03-12
TRACHEOSTOMY CLEANING TRAY (K840664)American Pharmaseal Div. Ahsc1984-03-12
FASCIA CUTTER (K834514)Stryker Corp.1984-03-12
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
PROTOZOA STAIN CONTROL (K840517)Scientific Device Laboratory, Inc.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
PARAMAX ALANINE AMINOTRANSFERASE (K840705)American Dade1984-03-09
AMS GRAM-NEGATIVE IDENT. CARD (K834269)Vitek Systems, Inc.1984-03-09
LEECO E2 QUANT DIAG. TEST KIT (K834586)Leeco Diagnostics, Inc.1984-03-09
YERSINIA SUPPLEMENT (K840615)Remel Co.1984-03-09
PHONATORY FUNCTION ANALYZER PS-77 (K832678)Kells Medical, 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
OP-CON SURGICAL INSTRUMENT #9 (K834540)Imm Enterprises , Ltd.1984-03-06
FPP IV SECURE (K840683)Fpp, Inc.1984-03-06
JAKOBI SURG. INSTRUMENTS #7 44/47 (K834189)Imm Enterprises , Ltd.1984-03-06
WILCOR-XR RP MEDICAL FILM (K834613)Cea America 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
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
CAT. 4-OBSTETRICS GYNECOLOGY DEV'S (K840308)Imm Enterprises , Ltd.1984-03-05
DISPOSABLE SYRINGE FILTERS (K840556)Corning Medical & Scientific1984-03-05
SDI PREPAX DILUKIT HW (K840041)Scientific Distributors, Inc.1984-03-05
VOLUME VENTILATOR CIRCUIT W/WATER TRAP (K834570)Airlife, Inc.1984-03-05
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