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

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RecordFirmDate
API ANAIDENT (K831032)Analytical Products, Inc.1983-05-05
HELENA BIOSTRIP PH (K830979)Helena Laboratories1983-05-05
HELENA BIOSTRIP K (K830976)Helena Laboratories1983-05-04
CULUTURE SET CHLAMYDIA ISOLATION AND (K830342)Immulok, Inc.1983-05-04
FLOW-PAC SGPT REAGENT (K830959)Amresco, Inc.1983-05-04
PLAN A LIFE (K830975)New Directions Co.1983-05-04
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY (K830964)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-05-04
PERSONAL KNEE CRUTCH PAD (K831149)Tecnol New Jersey Wound Care, Inc.1983-05-03
OXYGEN CONNECTING TUBE (K830988)Medovations, Inc.1983-05-03
AMPLIGREFFE (K830993)Prothia USA, Inc.1983-05-03
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA (K830923)Cygnus Research Corp.1983-05-03
TEMP-CHECK ADAPTOR, TEE-CONFIGURATION (K830922)Cygnus Research Corp.1983-05-02
SUCTION RESERVOIR (K830607)Sil-Med Corp.1983-05-02
TEMP-CHECK ADAPTOR, Y-CONFIGURATION (K830921)Cygnus Research Corp.1983-05-02
BBL STREP GROUPING KIT (K830510)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-05-02
ACUFEX UNIVERSAL LEG HOLDER (K830707)Acufex Microsurgical, Inc.1983-05-02
TRACHESTOMY & NASAL SUCTIONING KIT #- (K830711)Intertex Medical1983-05-02
I/A KIT (K830859)Surgeon Surgical Instrumentation, Inc.1983-05-02
FACEBOW FOR BALANCE ARTICULATOR (K830775)Almore Intl., Inc.1983-04-28
ANDREWS REMOTE CHUCK DRILL (K831043)Orthopedic Systems, Inc.1983-04-28
GLOMARK (K830703)Alphamedix, Inc.1983-04-28
MICROFIL CONTOURING INSTRUMENTS (K830776)Almore Intl., Inc.1983-04-28
BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU- (K830843)Rna Medical Corp.1983-04-28
MARKLEY THREADED WIRE (K830773)Almore Intl., Inc.1983-04-28
I/A KIT (K831159)Staar Surgical Co.1983-04-28
OSCAR COLOR VISION TESTER (K831074)Carl Zeiss, Inc.1983-04-28
HELENA BIOSTRIP P (K830977)Helena Laboratories1983-04-28
INFLATABLE INVALID RING (K830426)Maddak, Inc.1983-04-28
P & T MEDIUM (K831059)American Micro Scan1983-04-28
MARTIN PELVIC LIFT (K823206)Martin Pelvic Lift Co.1983-04-28
LIQUIPETTE (K831079)The Kendall Company Div. of Tyco Healthcare Group1983-04-28
E.T. STRAP #6000 (K830706)Rnd Medical Products, Inc.1983-04-28
I.E.C COLUMN (K830918)Berwick Medical Products, Inc.1983-04-27
MICRO-MITT (K830821)CooperVision, Inc.1983-04-27
PERSONAL ROMEAR (K823588)Romear Mfg., Inc.1983-04-27
GIREX (K831033)Lancer Assoc.1983-04-27
PHADEBACT STREP F TEST (K830445)Pharmacia, Inc.1983-04-27
IMMO PHASE DIRECT PROGESTERONE RADIO- (K830880)Corning Medical & Scientific1983-04-18
NUCLIPASE (I125) PANCREATIC LIPASE (K823860)Nuclear Diagnostics, Inc.1983-04-18
BED-CHECK: II-IFAC (K823926)Bed-Check Corp.1983-04-18
WAKO FREE CHOLESTEROL C TEST (K830761)Wako Chemicals USA, Inc.1983-04-18
PROTOPORPHYRIN ZN CONTROL (K830493)Kaulson Laboratories, Inc.1983-04-18
HUMIDIFIER, WITH OR WITHOUT ADAPTER (K830896)Airlife, Inc.1983-04-18
NOVA GAUZE (K830473)American Threshold Industries, Inc.1983-04-15
THYMINE/THYMIDINE DISCS DDG (K830939)Oxoid U.S.A., Inc.1983-04-13
WIRE TWISTERS (K830721)The Anspach Effort, Inc.1983-04-12
DSL 1900 (K830816)Diagnostic Systems1983-04-12
ONE TIME DISPOSABLE SKIN STAPLER (K830704)Acme United Corp.1983-04-12
IMSI/METRIPOND HAND OPERATING TABLE (K830339)Intl. Management Services, Inc.1983-04-12
PEM-C (K830397)Health Development Corp.1983-04-12
OLYMPUS HIGH SPEED ANALYZER (K830762)Olympus Corp.1983-04-12
VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (K830219)Ascep, Inc.1983-04-12
ADT DISPOSABLE SCALPEL W/STAINLESS STEEL (K830745)Lab Industries, Inc.1983-04-12
DISPOSABLE SKIN STAPLER (K830768)Surgeons Choice, Inc.1983-04-12
DISPOSABLE INTRA-ARTICULAR BLADE (K830434)Concept, Inc.1983-04-12
FREEDOM (K823849)Carbonite Corp.1983-04-12
MODEL 200 (K830468)Western Laboratories Corp.1983-04-12
INDUCTIVELY-COUPLED PLASMA SPECTROMETER (K830799)The Perkin-Elmer Corp.1983-04-12
NEGATIVE URINE CONTROL (K830834)Helena Laboratories1983-04-12
SUTTER CPM 5000 (K830974)Sutter Biomedical, Inc.1983-04-12
SUR-FIT FLEXIBLE (K830945)Convatec, A Division of E.R. Squibb & Sons1983-04-12
CHEMOTHERAPY INFUSION CATHETER (K822096)American Heyer Schulte1983-04-12
S & W MODEL SW 37 (K830874)S & W Enterprises, Inc.1983-04-08
MINI LANCET-BLOOD LANCET (K830705)Pharmaquest Corp.1983-04-08
CYNOX I HEMOGLOBINOMETER (K830569)Buffalo Medical Specialties Mfg., Inc.1983-04-08
VERI-STAPH (K830783)Zeus Technologies1983-04-08
ARTIMICROBIAL REMOVAL DEVICE (K830372)Marion Laboratories, Inc.1983-04-08
QUANTUM II BACTERIAL IDENT. SYSTEM (K830698)Abbott Laboratories1983-04-08
KNAI SODIUM POTASSIUM ANALYZER (K830805)Radiometer America, Inc.1983-04-08
URIC ACID COLORIMETRIC DETERMINATION (K830679)Dow Instruments & Reagents, Inc.1983-04-06
BINOCULAR MAGNIFIER 2X (K830774)Almore Intl., Inc.1983-04-06
ELECTRIC MOUTH MIRROR (K830777)Almore Intl., Inc.1983-04-06
PROVIDONE-IODINE PREP-PADS & TOWELETTES (K830394)H & P Industries, Inc.1983-04-06
BINOCULAR LOUPE (K830878)Almore Intl., Inc.1983-04-06
PROVIDONE-IODINE SWABSTICKS (K830393)H & P Industries, Inc.1983-04-06
KEMTEK 102 (K830751)Kemble Instruments, Inc.1983-04-06
ENSURE DRESSING (K830593)Warner-Lambert Co.1983-04-06
YEAST IDENT (K830286)Analytical Products, Inc.1983-04-05
ACTIVATED URIC ACID (K830616)American Monitor Corp.1983-04-05
ENCORE CHEMISTRY ANALYZER (K830641)Baker Instructions Corp.1983-04-05
FLUOROMETER, GENERAL USE (K830624)Abbott Diagnostics1983-04-05
HANDPIECE SYSTEM I/A (K830413)Uxtra Corp.1983-04-05
RADIOIMMUNOASSAY TEST SYSTEM PRL (K830412)Monobind1983-04-05
COLLAPSABLE LAVATORY SEAT HEIGHTENER (K830854)Lic-Orthion1983-04-05
SESAM TREATMENT TABLE (K830855)Lic-Orthion1983-04-05
ELISA PLUS SYSTEM (K830212)William-Palmer Industries, Inc.1983-04-05
RESI-WALKER (K830848)Lic-Orthion1983-04-05
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA (K830239)Emd Chemicals, Inc.1983-04-05
EMIT-ST PHOTOMETER & DILUTER VERIFICA (K830518)Syva Co.1983-04-05
DUPONT PREP TYPE AS EXTRACTION CARTRIDE (K830693)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
LEECO TESTOSTERONE DIAGNOSTIC KIT (K830512)Leeco Diagnostics, Inc.1983-04-05
DUPONT PREP OD EXTRACTION CARTRIDE (K830692)E.I. Dupont DE Nemours & Co., Inc.1983-04-05
OB TILT (K830849)Lic-Orthion1983-04-05
OB HELP ARM (K830842)Lic-Orthion1983-04-05
SHOWER STOOL W/HANDLES (K830852)Lic-Orthion1983-04-05
PEM-T (K830497)Hedeco1983-04-05
OB TRIPP TRANSPORT CHAIR (K830850)Lic-Orthion1983-04-05
HERPES-IHA KIT (K822095)Hillcrest Biologicals1983-04-05
BATH TUB SEAT & BATH BOARD (K830851)Lic-Orthion1983-04-05
PHADEBAS HUMYLASE CONTROL(H) (K823421)Pharmacia, Inc.1983-04-05
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Every clearance here is in the API, with alerts when new ones post.