Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BIO-CARB D16000, D16001, AND D17000 (K861646)Societe D' Analyses Bio-Pharmaceutiques,Inc.1986-08-07
DERMASCAN LASER SURGICAL HANDPIECE (K860083)Medical Laser Research & Development Corp.1986-08-07
I81 INITIALES (K862623)Oticon Corp.1986-08-07
C.S.M. HIP (K862752)Protek, Inc.1986-08-07
SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED (K861450)Kirschner Medical Corp.1986-08-07
ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE (K861331)Trimedyne, Inc.1986-08-07
TEC VARI-TRAC II TRACTION UNIT (K862846)Therapeutic Equipment Corp.1986-08-07
PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS (K862534)Walter Lorenz Surgical, Inc.1986-08-07
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM (K862505)Walter Lorenz Surgical, Inc.1986-08-07
NEOGUARD ECG ELECTRODES (K861364)Cas Medical Systems, Inc.1986-08-06
EUROMED S-601 (K862765)Lectec Corp.1986-08-06
MEDCOMP C.A.V.H. CATHETER (K862771)Medical Components, Inc.1986-08-06
TIMOTHY ALLERGEN DISC (K862174)Immuno Nuclear Corp.1986-08-06
DENTAL COTTON ROLLS, STERILE AND NON-STERILE (K861338)Intl. Verbandstoff-Fabrik Schaffhau1986-08-06
KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH (K862544)Suzuken Co., Ltd.1986-08-06
FLOSS CARD (K862694)Floss Card Co.1986-08-06
SYRINGE INJECTION GUN (K862853)Gastrotech, Inc.1986-08-06
SPERTILITE PHOTOTHERAPY LAMP (K862608)Cooper-Hewitt Electric Co.1986-08-06
S-ROM 135 POROUS COATED FEMORAL STEM COLLAR (K860207)Joint Medical Products Corp.1986-08-06
EM DIAGNOSTIC ECG ELECTRODE (K862746)Electromed Intl., Ltd.1986-08-06
PREMIE DISC ECG ELECTRODE W/PREATTACHED LEAD (K861246)Conmedcorp1986-08-06
TRU-TRAC 3-DIMENSIONAL CERVICAL TRACTION-TD-9000 (K862579)Tru-Trac1986-08-06
SIGNA II RESTING ECG ELECTRODE (K862655)Kone Instruments, Inc.1986-08-06
UNI-JET CONNECTOR (K862433)Acutronic Medical Systems AG1986-08-06
COULTER COUNTER MODEL S PLUS JUNIOR (K861780)Coulter Electronics, Inc.1986-08-06
MINI-TRACH KIT (K862167)Portex, Inc.1986-08-06
KALLESTAD SM/RNP TEST REAGENT (K862313)Kallestad Laboratories, Inc.1986-08-06
GOULD XCALIBER (K862344)Bio-Tek Instruments, Inc.1986-08-06
CTC 30, 40, 1 LIQUID OXYGEN LITERS (K860738)Cryodyne Technologies, Inc.1986-08-06
MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS (K861375)Sharp Electronics Corp.1986-08-06
GEREONICS BIOPOTENTIAL SKIN ELECTRODES (K861099)Gereonics, Inc.1986-08-06
PREGELLED INFANT DISPOSABLE ECG ELECTRODE (K862756)Labeltape Meditect, Inc.1986-08-06
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (K861984)Universal Medical Instrument Corp.1986-08-05
CORDIS ANCOR ACTIVE FIXATION LEAD (K832422)Cordis Corp.1986-08-05
6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION (K862698)Cooper Lasersonics, Inc.1986-08-05
CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR (K851064)Cordis Corp.1986-08-05
DIATRON BLOOD GLUCOSE METER (K855178)Dextron, Inc.1986-08-04
MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR (K861368)Medtronic Vascular1986-08-04
CHEMVARION(TM) (K862586)G.B.F. Industries, Inc.1986-08-04
AMPU-PAK (K860511)Ammerman Medical Enterprises, Inc.1986-08-04
AMIKACIN KIT (FPIA) (K862248)Windsor Laboratories, Inc.1986-08-04
USA ASPIRATOR (K862751)U. S. A. Medical Corp.1986-08-04
PERCEPTIVE SYSTEMS INC PSICOM 217 KARYOTYPING SYST (K861974)Perceptive Systems, Inc.1986-08-04
GAS-TRAK (K862278)United Diagnostics, Inc.1986-08-04
CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY (K862542)Supelco, Inc.1986-08-04
UTAK-STABBS TOXICOLOGY CONTROL (K862420)Utak Laboratories, Inc.1986-08-04
VACUTAINER BRAND AGAR SLANT (K862761)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-08-04
DIAGEM 300 BG REAGENT STRIPS (K854329)Seton Products, Inc.1986-08-04
TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (K862206)Micromedic Systems1986-08-04
FORETEL, COLOR OVULATION TEST (K860828)Nms Pharmaceuticals, Inc.1986-08-04
CHEMTROL(TM) (K862587)G.B.F. Industries, Inc.1986-08-04
TRU-KINETICS (TM) (K862780)Tru-Trac1986-08-04
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN (K860679)Orion Corp.1986-08-04
IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT (K862607)Boots-Celltech Diagnostics, Inc.1986-08-04
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 (K862703)Em Diagnostic Systems, Inc.1986-08-04
HOLLISTER WOUND CARE BARRIER (K862572)Hollister, Inc.1986-08-04
MIKROS, MIKROS VS-1, PULSE GENERATOR (K860922)Biotronik Sales, Inc.1986-08-04
PARAMAX LIPASE REAGENT (K862440)American Dade1986-08-04
LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL (K862185)Bio-Rad1986-08-04
SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHIC (K852331)Scholten Surgical Instruments, Inc.1986-08-01
DART AMYLASE-D.S. REAGENT SYSTEM (K862370)Coulter Electronics, Inc.1986-08-01
MP-XMO DISPOSABLE FACE MASK (K862784)Medipart Jerry Alexander1986-08-01
EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS (K862513)Cordis Corp.1986-08-01
SACCOMANNO SPECIMAN SOLUTION (K862725)Mill-Rose Laboratory1986-08-01
ITT INTERGRATED TABLE AND TUBESTAND (K862826)Garrels X-Ray Products, Inc.1986-08-01
CEILSTAND, MULTISTAND R & S AND THE BUCKYSTAND (K862734)D&R X-Ray Products, Inc.1986-08-01
I22 INITIALES (K862621)Oticon Corp.1986-08-01
REPLIANALYZER (K861958)Mct Medical, Inc.1986-08-01
MP-066 RADIOAEROSOL KIT (K862792)Medipart Jerry Alexander1986-08-01
FCW TUBE STAND (K862827)Garrels X-Ray Products, Inc.1986-08-01
PDQ AMEBIASIS (K862473)Diamedix Corp.1986-08-01
MP-01X-I DISPOSABLE FILTER KIT (K862790)Medipart Jerry Alexander1986-08-01
MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER (K862787)Medipart Jerry Alexander1986-08-01
ULTRAHESIVE II POSTOP ELECTRODE (K862028)Medical Devices, Inc.1986-08-01
MP-XMV DISPOSABLE FACE MASK (K862783)Medipart Jerry Alexander1986-08-01
STANDARD BASIN KIT CUSTOM BASIN KIT (K862241)Quali-Med, Inc.1986-08-01
CUSTOM IN-THE-EAR AND CANAL HEARING AID (K862754)Cochlear Laboratories, Ltd.1986-08-01
MP-50T DISPOSABLE BREATHING CIRCUIT FILTER (K862786)Medipart Jerry Alexander1986-08-01
BSX BUCKY-STAND (K862828)Garrels X-Ray Products, Inc.1986-08-01
STA-SOF BREAST COMPRESSOR-CLAMP (K862731)Sta-Sof, Inc.1986-08-01
MP-1204 DISPOSABLE BACTERIA FILTER (K862785)Medipart Jerry Alexander1986-08-01
MICROCOR E.C.G. MONITOR WITH A.C. ADAPTER (K861281)Microcor, Inc.1986-08-01
MP-4400 MOUTHPIECE-FLANGE SEAL (K862788)Medipart Jerry Alexander1986-08-01
MECHANICAL CYSTITOME (K862709)Rudolph Beaver, Inc.1986-08-01
MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS (K862523)Walter Lorenz Surgical, Inc.1986-08-01
DISPOSABLE SHOE COVERS AND NURSES CAPS (K862726)Abco Dealers, Inc.1986-08-01
MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE (K862533)Walter Lorenz Surgical, Inc.1986-08-01
SURGICAL PLASTERS (K861695)Salvaplast Industries1986-08-01
SONORANGER TRANSVAGINAL PROBE (K862627)Ausonics Pty , Ltd.1986-08-01
MP-01X DISPOSABLE BACTERIA FILTER KIT (K862789)Medipart Jerry Alexander1986-08-01
MP-070 RADIOAEROSOL KIT (K862794)Medipart Jerry Alexander1986-08-01
MULTI-CHANNEL MICROPIPETTES (K862802)Dynatech Laboratories, Inc.1986-08-01
MP-30XM-IE FACE MASK AND FILTER KIT (K862791)Medipart Jerry Alexander1986-08-01
MP-XMM DISPOSABLE FACE MASK (K862781)Medipart Jerry Alexander1986-08-01
I81 CITE (K862624)Oticon Corp.1986-08-01
MP-070-M RADIOAEROSOL KIT (K862795)Medipart Jerry Alexander1986-08-01
MP-XML DISPOSABLE FACE MASK (K862782)Medipart Jerry Alexander1986-08-01
ULTRATHERM 808 I (K862589)Elmed, Inc.1986-08-01
UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (K862666)Mallinckrodt Critical Care1986-08-01
I22 CITE (K862622)Oticon Corp.1986-08-01
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Track 1986 automatically

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