Atlas FDA

1986

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

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RecordFirmDate
STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH (K862006)Cordis Corp.1986-06-27
RAICHEM CHOLINESTERASE REAGENT (K862168)Reagents Applications, Inc.1986-06-27
WORTHINGTON HDL PRECIPITATING REAGENT SET (K861926)Cooper Biomedical, Inc.1986-06-27
TRIGLYCERIDES GPO-TRINDER (K861635)Catachem, Inc.1986-06-27
RICH-MAR SPINA-MOBILIZOR (K861832)Rich-Mar Corp.1986-06-27
CRESOLPHTHALEIN COMPLEXONE, CALCIUM (K860664)Amresco, Inc.1986-06-27
ARIZONA CONDYLAR TIBIAL PLATEAU (K862125)Depuy, Inc.1986-06-27
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (K861428)American Omni Medical, Inc.1986-06-26
JELTRODE (K861956)Henley Intl.1986-06-26
MODEL CA, HEARING AID (K862095)Fine-Tune1986-06-26
EOH 8501 OSSEOINTEGRATED IMPLANT SYSTEM (K861502)Dr. Harold Bergman1986-06-26
PAP SMEAR KIT (K862242)Quali-Med, Inc.1986-06-26
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD (K860846)Cordis Corp.1986-06-26
HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (K861846)Solar Dental Co., Inc.1986-06-26
PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY (K861422)Pacesetter Systems1986-06-26
OXYGENATOR MODEL NOS. BENTLEY-10A & BENTLEY-10B (K860673)American Bentley1986-06-26
SCHERER PORTABLE TOOTH POLISHER (K860264)Scherer Laboratories, Inc.1986-06-26
FAST FORMALERT (K853555)Organon Teknika Corp.1986-06-26
ORG-7201 MULTIPARAMETER TELEMETRY MONITOR (K860239)Nihon Kohden America, Inc.1986-06-26
X-MAT (K862144)Combined Concepts, Inc.1986-06-25
DIRECT BILIRUBIN PROCEDURE (K861671)Data Medical Associates, Inc.1986-06-25
HYGEIA RAPID STREP A TEST (K862133)Hygeia Sciences1986-06-25
ALT (SGPT) REAGENT SET (UV RATE) (K862209)Sterling Diagnostics, Inc.1986-06-25
SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE (K861899)3M Company1986-06-25
KHURI REGIONAL TISSUE PH MONITOR (K862114)Vascular Technology Incorporated1986-06-25
ALT-30, 60 AND 100 (K861366)Dimension Diagnostics1986-06-25
GENTAMICIN (FPIA) CALIBRATOR KIT (K861769)Windsor Laboratories, Inc.1986-06-25
ULTRALITE HF1236 HAND AND FOOT SYSTEM (K861963)Ultralite1986-06-25
ASSERA-PLATE PROTEIN C KIT (K861475)American Bioproducts Co.1986-06-25
TOBRAMYCIN (FPIA) CALIBRATOR KIT (K861891)Windsor Laboratories, Inc.1986-06-25
PHENYTOIN (FPIA) CALIBRATOR KIT (K861770)Windsor Laboratories, Inc.1986-06-25
ASSERA-PLATE VWF KIT (K861417)American Bioproducts Co.1986-06-25
FITTRONIC (K861796)Corleone Intl. Traders, Inc.1986-06-25
COMPANION LIQUID OXYGEN SYSTEM (K861503)Puritan Bennett Corp.1986-06-25
WRIST ACTIGRAPH (K854030)Ambulatory Monitoring, Inc.1986-06-25
DOUBLE ANTIBODY CALCITONIN RIA KIT (K861274)Diagnostic Products Corp.1986-06-25
THEOPHYLLINE (FPIA) CALIBRATOR KIT (K861768)Windsor Laboratories, Inc.1986-06-25
BARD-PARKER CAROTID SHUNT (K860136)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-06-25
S80 IMPLANTABLE CARDIAC PACING LEAD (K854963)Sorin Biomedica, Fiat, USA, Inc.1986-06-24
DELFIA (TM) HFSH KIT (K862043)Lkb Instruments, Inc.1986-06-24
MODEL HP HEARING AID (K862036)Fine-Tune1986-06-23
MODEL UC SPECTRUM IN-THE-CANAL HEARING AID (K862104)Miracle-Ear/Dahlberg, Inc.1986-06-23
STREAM-SWITCH MANIFOLD (K861209)Intelligent Medicine, Inc.1986-06-23
MODEL UC IN-THE-CANAL HEARING AID (K862103)Miracle-Ear/Dahlberg, Inc.1986-06-23
PTT AUTOMATE TEST KIT (K861190)American Bioproducts Co.1986-06-23
SHOFU LINING CEMENT (K862280)Shofu Dental Corp.1986-06-23
SARNS PORTABLE POWER MODULE (K861388)3M Health Care, Sarns1986-06-23
ST-90 SPIRO ANALIZER (K861487)Future Impex Corp.1986-06-23
MODEL PC HEARING AID (K861939)Fine-Tune1986-06-23
DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID (K862099)Miracle-Ear/Dahlberg, Inc.1986-06-23
UCS-2, ULTRASONIC CLEANING SOLUTION (K861147)Keymed, Inc.1986-06-23
LIFESOUND CUSTOM ITE (K862050)Lifesounds, Inc.1986-06-23
LIFECARE REMOTE ALARM #34-001 (K862212)Lifecare Services, Inc.1986-06-23
ENTERNAL INFUSER MULTIPUMP 203 (K861040)Medix Medical Electronics (U.S.A.), Inc.1986-06-23
PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM (K862021)Ultramed, Inc.1986-06-23
MODEL KM IN-THE-CANAL HEARING AID (K862102)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL UM IN-THE-CANAL HEARING AID (K862101)Miracle-Ear/Dahlberg, Inc.1986-06-23
MODEL ED BEHIND-THE-EAR HEARING AID (K862100)Miracle-Ear/Dahlberg, Inc.1986-06-23
SEALITE (K862284)Sybron Corp.1986-06-23
PORTALASE 200 CARBON DIOXIDE SURG LASER NEUROLOGIC (K854468)Minnesota Laser Corp.1986-06-20
#6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL (K861903)Cooper Lasersonics, Inc.1986-06-20
MEDNOVA BLOOD PRESSURE CUFF (K854813)Mednova Corp.1986-06-20
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT (K861499)Biostar Medical Products, Inc.1986-06-20
PORTALASE 300 CARBON DIOXIDE SURG LASER NEUROLOGIC (K854473)Minnesota Laser Corp.1986-06-20
SDL-300 (K854337)Shimadzu Corp.1986-06-20
WHITE OAK ALLERGEN DISC (K862175)Immuno Nuclear Corp.1986-06-20
PERSUNAL TAN, MODEL NO. HU-0208L (K862263)Sunthetic Engineering, Inc.1986-06-20
SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM (K862048)Murex Corp.1986-06-19
LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (K862022)Lic-Orthion1986-06-19
ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORY (K861372)Snowden-Pencer1986-06-19
WISE IRIDOTOMY-SPINCTEROTOMY LENS (K861648)Ocular Instruments, Inc.1986-06-19
NO. 100352 GALVANIC OXYGEN SENSOR (K862113)Vascular Technology Incorporated1986-06-19
LENS-EZE (K862094)Insight International, Inc.1986-06-19
HIGH EFFICIENCY HEMODIALYSIS SYSTEM (K861776)Travenol Laboratories, S.A.1986-06-19
BALL ELECTRODES (K861595)National Wire & Stamping, Inc.1986-06-19
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES (K861377)Cordis Corp.1986-06-19
ELECTROSURGICAL BLADE ELECTRODE (SOLID TYPE) (K861495)National Wire & Stamping, Inc.1986-06-19
ACUSON S228, S519 & L558 TRANSDUCERS (K861577)Acuson Computed Sonography1986-06-19
STERILE LAPAROTOMY GAUZE SPONGE (K862126)Anago, Inc.1986-06-19
ELECTROSURGICAL NEEDLE ELECTRODE (SOLID TYPE) (K861594)National Wire & Stamping, Inc.1986-06-19
ENTRAVISION EP-500 I/A ECCO PACK (K862064)Entravision, Inc.1986-06-19
ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE (K862063)Entravision, Inc.1986-06-19
IMMPULSE FERRITIN ASSAY REAGENT (K862014)Sclavo, Inc.1986-06-19
HCI MECONIUM ASPIRATOR (K862132)Hospital Concepts, Inc.1986-06-19
TERUMO SENSIBEAD EIA TSH KIT (K861573)Terumo Medical Corp.1986-06-19
STACLOT PROTEIN C TEST KIT (K861079)American Bioproducts Co.1986-06-19
MODIFIED NEUROMUSCULAR TRANSMISSION MONITOR (K862149)Puritan Bennett Corp.1986-06-19
RMP COMPANT CRICOTHYROTOMY EQUIPMENT STORAGE TRAY (K862197)Rmp Co.1986-06-19
MODEL RS-3 RADIOGRAPHIC STAND (K861995)Medicor USA , Ltd.1986-06-19
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR (K861707)Siemens Elema AB1986-06-19
PORT-A-TRAC (K861554)Port-A-Trac Co.1986-06-19
MODIFIED TELEFLEX MEDICAL INTRODUCER CATHETER (K861951)Teleflex, Inc.1986-06-19
QUALI-MED'S OPERATING ROOM DRAPES (K862172)Quali-Med, Inc.1986-06-19
SWAN-NECK PERITONEAL DIALYSIS CATHETERS (K862046)Accurate Surgical Instruments Co.1986-06-19
SKYLARK MODEL 1001 TENS DEVICE (K853898)Peleg Intl. Co.1986-06-18
ENDO-LASE CD40 FOR NEUROSURGERY (K853900)Endo Lase, Inc.1986-06-18
BIOFEEDBACK MICROLAB (K860271)Hrm Software/Div. of Human Relations Media1986-06-18
ATI DISPOSABLE BIOLOGICAL TEST PACK (K855120)Parke-Davis Co.1986-06-18
FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES (K862267)Bivona Medical Technologies1986-06-18
COMPASS CT STEREOTACTIC ADAPTATION SYSTEM (K862220)Stereotactic Medical Systems, Inc.1986-06-18
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Every clearance here is in the API, with alerts when new ones post.