Atlas FDA

1986

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

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RecordFirmDate
AMBER-CHEST (K862616)Old Delft Corp. of America1986-09-02
OLBERT CATHETER SYSTEM WITH SIDEWINDER CURVE (K862550)Meadox Surgimed, Inc.1986-09-02
SURGI-WIPES (K863278)Dermacare Products, Inc.1986-09-02
KEISEI SCALPEL (STERILE AND NON-STERILE) (K863213)Keisei Medical Industrial Co., Ltd.1986-09-02
REXILLIUM N. B. F. (K862822)Jeneric Ind.1986-09-02
KEISEI HANDLES FOR SURGICAL BLADES (K863212)Keisei Medical Industrial Co., Ltd.1986-09-02
MARTIN MEDICAL PRO-SPEC MEDIUM VAGINAL SPECULUM (K863274)Martin Medical1986-09-02
OSTEONICS SHOULDER PROSTHESIS (K862535)Osteonics Corp.1986-09-02
ACROMED ADS BONE NAIL (K862552)Buckman Co., Inc.1986-09-02
CONCEPT ARTHROSCOPY RASP (K862659)Concept, Inc.1986-09-02
HA-2 HUMAN BODY COMPOSITION ANALYZER (K860749)Dj Medical Instrument Corp. C/O Keller & Heckman1986-09-02
MARTIN MEDICAL PRO-SPEC SMALL VAGINAL SPECULUM (K863275)Martin Medical1986-09-02
2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP (K862689)W. L. Gore & Associates, Inc.1986-09-02
KEISEI SURGICAL BLADES (STERILE & NON-STERILE) (K863211)Keisei Medical Industrial Co., Ltd.1986-09-02
KEISEI MICRO-BLADES (STERILE AND NON-STERILE) (K863214)Keisei Medical Industrial Co., Ltd.1986-09-02
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW (K862230)Buckman Co., Inc.1986-08-29
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC (K863201)Allergan, Inc.1986-08-29
THORACIC CATHETER (CHEST DRAINAGE TUBE) (K863142)Sheridan Catheter Corp.1986-08-29
DESERET FLO-THRU INJECTATE TEMPERATURE SENSOR (K862119)Parke-Davis Co.1986-08-29
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 (K863005)Em Diagnostic Systems, Inc.1986-08-29
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 (K862845)Em Diagnostic Systems, Inc.1986-08-29
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV (K862540)Gish Biomedical, Inc.1986-08-29
PERCU GUIDE I (LOOP TYPE) (K863090)E-Z-Em, Inc.1986-08-29
ALP (OPT) REAGENT (K862905)Sigma Diagnostics, Inc.1986-08-29
SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC (K861708)General Electric Co.1986-08-29
AMIKACIN (FPIA) CALIBRATOR KIT (K863244)Windsor Laboratories, Inc.1986-08-29
OMC ORTHOMET CANNULATED SCREW (K862157)Orthomet, Inc.1986-08-29
NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K862876)Block Drug Company, Inc.1986-08-29
GAMBRO ANALYZ MON GLUCOSE/AM-G & DISP AM-G TUB SET (K860682)Gambro, Inc.1986-08-29
AXIOM TROCAR THORACIC CATHETER (K863247)Axiom Medical, Inc.1986-08-29
AVL MODEL 984 ELECTROLYTE ANALYZER (K862819)Avl Scientific Corp.1986-08-29
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) (K863094)Em Diagnostic Systems, Inc.1986-08-29
CHILD'S ROLLS POWERED WHEELCHAIR (K863250)Invacare Corp.1986-08-29
CIBA CORNING MAGIC LITE TSH IMMUNOASSAY (K862407)Ciba Corning Diagnostics Corp.1986-08-29
J.K. TEMPLETON EAR PIERCING GUNS/INSTRUMENTS/STUDS (K860678)Jay Kenny Templeton1986-08-29
BICORD BY QMED (K863091)Qmed, Inc.1986-08-29
SCHNEIDER-SHILEY FLUSHING CATHETER (K862466)Shiley, Inc.1986-08-29
VACU-GUARD (K863162)Arbor Technologies, Inc.1986-08-29
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER (K862005)Laserscope1986-08-29
SURGICAL VITEX (K862926)Jeneric Ind.1986-08-29
OSCOR MEDICAL FIX SCREW PACING LEAD/PEELABLE CATH (K861493)Oscor Medical Corp.1986-08-28
BURDICK DIVISION (E-500) (K861850)Mortara Instrument, Inc.1986-08-28
ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (K861761)Travenol Laboratories, S.A.1986-08-28
CERYX PACEMAKER MODELS 114, 314 & 614 (K854790)Vitatron Medical BV1986-08-28
SIEMENS-ELEMA (SICARD-P) (K861851)Mortara Instrument, Inc.1986-08-28
SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR (K862464)Shiley, Inc.1986-08-28
MINIOX 100 PULSE OXIMETER (K862798)Catalyst Research Corp.1986-08-28
EXEL BUTTERFLY SCALP VEIN SET (K862491)Exel Intl.1986-08-27
AGAR REDUCTION IN FORMULA FOR PDC 110 & 310 MEDIA (K863164)Precision Dynamics Corp.1986-08-27
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT (K855046)Abbott Laboratories1986-08-27
VITAGUARD PERCUTANEOUS INFECTION CONTROL KIT (K861563)Vitaphore Corp.1986-08-27
CADD-1, MODEL 5100 HF (K862927)Deltec Systems, Inc.1986-08-27
EMPI, MODEL 1000 HAND HELD ELECTRODE (K862231)Empi1986-08-27
ANAEROBE RAPID CHROMOGENIC ID PANEL (K862332)American Micro Scan1986-08-27
I.V. SET WITH AND WITHOUT AIR VENT (K860952)Migada, Ltd.1986-08-27
KIMLON DISPOSABLE BLANKET (K863179)Kimberly-Clark Corp.1986-08-27
TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT (K854944)Abbott Laboratories1986-08-27
PHASE II FERRITIN RADIOIMMUNOASSAY KIT (K862960)Medical & Scientific Designs, Inc.1986-08-27
BUNN MODEL 22 OXYGEN FLOW CONTROLLER (K861199)The John Bunn Co.1986-08-26
PIK POCKET (IRRIGATING TIP) (K863131)Teledyne, Inc.1986-08-26
CB BUR (K863097)Beavers Dental, Div. Sybron Canada, Ltd.1986-08-26
PULMANEX TM (MODIFICATION) (K863026)Life Design Systems, Inc.1986-08-26
BUN (RATE) REAGENT (K863196)Sigma Diagnostics, Inc.1986-08-26
VISIBLE-CHLAMYDIA(TM) TEST SYSTEM (K862638)Isolab, Inc.1986-08-26
ELECTROPHORESIS WORK CENTER (EWC) (K861414)Helena Laboratories1986-08-26
OTICON I31 CITE HEARING AID (K862980)Oticon Corp.1986-08-26
PC-PLAN (K862065)Dosimetrix, Inc.1986-08-26
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) (K861386)Eastman Kodak Company1986-08-26
KULZER GLASS IONOMER LINER (K863141)Shofu Dental Corp.1986-08-26
PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR (K862856)Austenal Dental, Inc.1986-08-26
DAKO ITA SYSTEM (K861059)Dako Corp.1986-08-25
PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER (K860289)Professional Health Technologies, Inc.1986-08-25
860 COLOR DOPPLER OR COLORVIEW 860 (K861538)Ge Medical Systems Information Technologies1986-08-25
OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 (K860488)Cas Medical Systems, Inc.1986-08-25
AMNIOINFUSION CATHETER (K862182)Michael Reese Hospital and Medical Center1986-08-25
ACCULEVEL PHENYTOIN TEST (K855026)Syva / A Syntex Co.1986-08-25
[CENTRAL VENOUS][MULTI-LUMEN] CATHETER W/FLEX TIP (K862056)Arrow Intl., Inc.1986-08-25
MICRA MICROSURGICAL INSTRUMENTS (K862971)Cordis Corp.1986-08-25
CORNEAL MODELING SYSTEM (K862379)Computed Anatomy, Inc.1986-08-25
SARA RT (K862880)Alleghany Intl. Medical Technology1986-08-25
ACCULEVEL PHENOBARBITAL TEST (K854607)Syva Co.1986-08-25
CIRCADIAN STRESS TEST SYSTEM (K860973)Circadian, Inc.1986-08-25
MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION (K862748)Cambridge Medical Instruments, Inc.1986-08-25
LIFESCAN EVOKED POTENTIAL SYSTEM (K861900)Neurometrics1986-08-25
WYLER SPHENOIDAL ELECTRODE (K861031)Ad-Tech Medical Instrument Corp1986-08-25
MINI-HOLTER, MODEL 2000 (K862526)Holter Recorders1986-08-25
MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR (K861504)Fukuda Denshi USA, Inc.1986-08-25
ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (K861981)Vital Signs, Inc.1986-08-25
CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE (K862953)Classic Medical Products, Inc.1986-08-25
MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS (K862244)Cordis Corp.1986-08-25
ABRAHAM YAG LASER LENS (K862868)Ocular Instruments, Inc.1986-08-21
CELLMATICS RSV DETECTION SYSTEM (K862321)Difco Laboratories, Inc.1986-08-21
MERIVAARA GERIATRIC CHAIR MODEL 455 (K862957)Global Medical Prods, Inc.1986-08-21
ABRAHAM IRIDECTOMY LENS (YAG LASER) (K862713)Ocular Instruments, Inc.1986-08-21
HOSKINS NYLON SUTURE LASER LENS (K862728)Ocular Instruments, Inc.1986-08-21
CBC-CAL (TM) PLUS/MULTIPLE (K862858)R&D Systems, Inc.1986-08-21
PETRUS SINGLE MIRROR LASER LENS (K862869)Ocular Instruments, Inc.1986-08-21
KEELER FIBEROPTIC HEADLAMP (K861747)Keeler Instruments, Inc.1986-08-21
SITE DISPOSABLE FIBEROPTIC ILLUMINATOR AND CABLE (K862943)Site Microsurgical Systems, Inc.1986-08-21
I.D.C. STANDUP WHEELCHAIRS (K863118)Intl. Diffusion Consommateur1986-08-21
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Every clearance here is in the API, with alerts when new ones post.