Atlas FDA

1986

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

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RecordFirmDate
LUNG MECHANICS SOFTWARE PROGRAM (K864105)Siemens Elema AB1986-11-07
HITACHI ELECTRONIC THERMOMETER MODEL HK-10TA (K864089)Hitachi Sales Corporation of America1986-11-07
LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III (K864137)Bio-Rad1986-11-07
DECITEL AUSCULSCOPE (K860994)Bloomfield Research and Development, Inc.1986-11-07
COOK-VPI INTERMITTENT CATHETER (K863082)Cook Urological, Inc.1986-11-07
NORELCO ELECTRNIC DIGITAL BLOOD PRESSURE METER (K855177)Philips Park1986-11-07
BUNN CONCENTRATOR MODEL 2011 WITH DEMAND VALVE (K861435)The John Bunn Co.1986-11-07
TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU (K864115)Cathaid, Inc.1986-11-07
NESBIT EVANS NURSING HOME BED (K864203)J. Nesbit Evans & Co.1986-11-07
SCHEIN AP-1 AIR POLISHING UNIT (K862384)Henry Schein, Inc.1986-11-07
PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) (K864167)Datascope Corp.1986-11-06
PIASTRINIT (K863114)J. D. Assoc.1986-11-06
AMICON DIAFILTER HEMOFILTER (K863823)Amicon, Inc.1986-11-06
FRESENIUS HEMOFLOW F50 & F70 (K864169)Seratronics, Inc.1986-11-06
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR (K860734)Marquette Electronics, Inc.1986-11-06
GAMBRO BICARBONATE MONITOR BCM 10-2 (K864083)Gambro, Inc.1986-11-06
NATURAL DETECTOR SYSTEM (K861731)U.S. Health Resources Corp.1986-11-06
LIGACLIP 20/20* MULTIPLE CLIP APPLIER (K864102)ETHICON, Inc.1986-11-05
SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES (K864175)Fraass Survival Systems, Inc.1986-11-05
UNIDEX GLUCOSE TEST STRIP (K862984)Unidex, Inc.1986-11-05
DU PONT PHENYTOIN ASSAY AND CALIBRATOR (K863888)E.I. Dupont DE Nemours & Co., Inc.1986-11-05
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 (K863738)Em Diagnostic Systems, Inc.1986-11-05
SERUM CLONAZEPAM TOXICOLOGY CONTROL (K862421)Utak Laboratories, Inc.1986-11-05
MONO ACU-SLIDE TEST (K861211)Cal-Tech Diagnostics, Inc.1986-11-05
SMI MULTIPETTOR(TM) (K863887)American Dade1986-11-05
VMAX KINETIC MICROPLATE READER (K863802)Molecular Devices Corp.1986-11-05
LYTENING 2 (K863521)Amdev, Inc.1986-11-05
WIDEX HEARING AID MODEL ES2 (K864097)Widex Hearing Aid Co., Inc.1986-11-05
ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT (K863490)Ortho Diagnostic Systems, Inc.1986-11-05
OXOID SIGNAL BLOOD CULTURE SYSTEM (K862946)Oxoid U.S.A., Inc.1986-11-05
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT (K861425)Core-Vent Corp.1986-11-05
RANFAC CUT BIOPSY NEEDLE (K864139)Ranfac, Corp.1986-11-05
THEOFAST(TM) TEST PACKAGE (K863475)3M Company1986-11-05
METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM (K863840)E.I. Dupont DE Nemours & Co., Inc.1986-11-05
DEKNATEL GWATHMEY VASCULAR STAPLING KIT (TENATIVE) (K864146)Cardio Thoracic Systems1986-11-05
INTEGRA, CUSTOM IN-THE-EAR HEARING AID (K864180)Bernafon, Inc.1986-11-05
HCG CONTROL KIT (K863744)Monoclonal Antibodies, Inc.1986-11-05
CRAIG NASO-GASTRIC TUBE HOLDER (K862855)Henley Intl.1986-11-04
BILIARY BALLOON CATHETER (K863571)Uresil Corp.1986-11-04
DIAGNOSTIC REAGENT PET-RPLA (K855235)Oxoid U.S.A., Inc.1986-11-04
SHEATH, ENDOSCOPE (K862059)Endovations1986-11-04
DIAGNOSTIC REAGENT SET-RPLA (K855233)Oxoid U.S.A., Inc.1986-11-04
CARDIOSCAN WITH DOPPLER OPTION (K862913)Interspec, Inc.1986-11-04
MARTIN MEDICAL PRO-SCOPE ANOSCOPE (K863273)Martin Medical1986-11-04
TUBEGRIPPER, UROLOGICAL CATHETER & ACCESSORY (K863958)Cathaid, Inc.1986-11-04
ESOPHAGEAL/RECTAL TEMPERATURE PROBE W/TYPE T (K864044)Respiratory Support Products, Inc.1986-11-04
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE (K863385)Cook Urological, Inc.1986-11-04
RESPIRONICS PTL REVIVEEASY (K863172)Respironics, Inc.1986-11-04
GENTLE FEEL (K864176)Mali, Inc.1986-11-04
MODEL XE-103 XENON/MASTER II (K863996)Medi Nuclear Corp., Inc.1986-11-04
OSRAM ULTRAMED 400 W (K863937)Osram GmbH1986-11-04
DIAGNOSTIC REAGENT TST-RPLA (K855236)Oxoid U.S.A., Inc.1986-11-04
BIO-GUARD AB COATED CATHETER (K863354)Cook Urological, Inc.1986-11-04
SM-20 CARDIOSCAN DOPPLER OPTION WITH CFM700 PROBES (K863372)Interspec, Inc.1986-11-04
EUP-012I, EUP-012J & EUB-0124 ULTRASONIC SCANNER (K862164)Hitachi Medical Corp. of America1986-11-04
DIAGNOSTIC REAGENT VET-RPLA (K855234)Oxoid U.S.A., Inc.1986-11-04
MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD (K863781)Intermedics, Inc.1986-11-03
DEGUPAL (K864162)Degussa Dental, Inc.1986-11-03
TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- (K863858)Hybritech, Inc.1986-11-03
MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (K863353)Grason-Stadler, Inc.1986-11-03
CORDIS CONTRAST INJECTION LINES (K864141)Cordis Corp.1986-11-03
SUPPORT ARM (K864117)Leonard Medical, Inc.1986-11-03
E-VAC(TM) (K862875)Laerdal California, Inc.1986-11-03
HITACHI HAND HELD MASSAGER A/C POWERED (K864088)Hitachi Sales Corporation of America1986-11-03
MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER (K864048)Intermedics, Inc.1986-11-03
EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS (K862260)Syva Co.1986-11-03
CALIBRATION GAS FOR SERVO GAS MONITOR 120 (K863675)Siemens Elema AB1986-11-03
SOMATICS MOUTH GUARD (BITE BLOCK) (K864181)Somatics, Inc.1986-11-03
WALRUS: DOUBLE BALLOON SHUNTING CATHETER (K862190)Medical Parameters, Inc.1986-11-03
MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER (K864047)Intermedics, Inc.1986-11-03
UPDATED STERILE ENDOTRACHEAL BRUSHES (K863635)Biological & Environmental Control Laboratories1986-11-03
TRANS- CIRCOTHYROTOMY DEVICE (ACC. RAVUSSIN) (K862436)Acutronic Medical Systems AG1986-11-03
SR-IVOLEN TRAY MATERIAL (K863421)Ivoclar USA, Inc.1986-11-03
THORNTON TITANIUM FORCEPS (VARIOUS TYPES) (K863992)Keeler Instruments, Inc.1986-10-31
XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES (K863986)American Edwards Laboratories1986-10-31
GRIESHABER GLOBAL CONTROL TUBING SET (K863444)Grieshaber & Co.1986-10-31
THORNTON TITANIUM SILVER SPATULA (K863990)Keeler Instruments, Inc.1986-10-31
QUINTON Q.CATH (K862740)Quinton, Inc.1986-10-31
MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB (K863581)The Kendal Co.1986-10-31
THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (K863989)Keeler Instruments, Inc.1986-10-31
PACO-FOLDER (TM) INTRAOCULAR LENS FORCEPS (K864003)Allergan, Inc.1986-10-31
CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY (K863537)Cordis Corp.1986-10-31
HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER (K862949)Oscor Medical Corp.1986-10-31
TRYCOPHYTON AGARS (K864100)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-31
LUER LOCK SKIRT (K862451)Hewlett-Packard Co.1986-10-31
CARDIOLIFE TEC 7200 (K863405)Nihon Kohden America, Inc.1986-10-31
FOLEY CATHETERS (K863517)Instrumentation Industries, Inc.1986-10-31
THORTON TITANIUM NEEDLEHOLDERS(NO,W CATCH & STAND (K863991)Keeler Instruments, Inc.1986-10-31
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE (K864078)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-10-31
BI-PLANE TRANSRECTAL PROBE NUMBER H4221T (K862911)General Electric Co.1986-10-31
MIRALITE (K863246)Mira, Inc.1986-10-31
CARE + PLUS IRREGATION TRAY (K863281)Welmed Systems, Inc.1986-10-31
MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE (K863547)Medtronic Vascular1986-10-31
FIXATION INSTRUMENTS (K863727)Medical Technology Development Corp.1986-10-31
DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS (K863040)Cher Mel Corp.1986-10-31
CARE + PLUS CATHETER CARE TRAY (K863282)Welmed Systems, Inc.1986-10-31
VTS REPORTER OR VTS LINK (K863993)Sensory Aids Corp.1986-10-31
THE ERGOSYSTEM CHAIR (K863728)Charles D. Bell, Inc.1986-10-31
TDMAC-HEPARIN COATED RMI CAROTID BY-PASS SHUNT (K862634)Research Medical, Inc.1986-10-31
CATARACT DIAMOND KNIFE (K863725)Medical Technology Development Corp.1986-10-31
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Every clearance here is in the API, with alerts when new ones post.