Atlas FDA

1986

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

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RecordFirmDate
SYRINGE PUMP: VM 07 (K860218)Vial Medical , Ltd.1986-04-07
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II (K860765)Em Diagnostic Systems, Inc.1986-04-07
EMDS ENZYME VERIFIER, LEVELS I & II (K860764)Em Diagnostic Systems, Inc.1986-04-07
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER (K860746)Travenol Laboratories, S.A.1986-04-07
CLINISET INFUSION SET (K860322)Zimmar Consulting , Ltd.1986-04-07
L D H-L (LACTIC DEHYDROGENASE) REAGENT (K860728)Trace Scientific , Ltd.1986-04-07
ENZYMATIC GLUCOSE REAGENT (HEXOKINASE) (K860724)Trace Scientific , Ltd.1986-04-07
SAMPLE MANIFOLD HOLDER (K860889)R. Bell1986-04-07
AST(GOT) (ASPARTATE AMINOTRANSFERASE) REAGENT (K860725)Trace Scientific , Ltd.1986-04-07
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM (K860675)Puritan Bennett Corp.1986-04-07
ALPHA-AMYLASE TEST (K860665)Sclavo, Inc.1986-04-07
AVL MODEL 983 ELECTROLYTE ANALYZER (K861087)Avl Scientific Corp.1986-04-07
MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL (K860028)Self Care Systems, Inc.1986-04-07
GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS (K860938)Gambro, Inc.1986-04-07
HURWITZ DIALYSIS CATHETER (K860094)Gish Biomedical, Inc.1986-04-07
TELESCOPE PROTECTION TUBE (K860265)R. J. Ltd., Ind.1986-04-07
G.T. (GAMMA-GLUTAMYL TRANSFERASE) REAGENT (K860723)Trace Scientific , Ltd.1986-04-07
HGM, INC. LASERCATH (STERILE) (K860357)Hgm, Inc.1986-04-07
ENZYMATIC TRIGLYCERIDES REAGENT (SINGLE VIAL) (K860730)Trace Scientific , Ltd.1986-04-07
FRESENIUS HEMOFLOW F80 DIALYZER (K861106)Seratronics, Inc.1986-04-07
LDH-P (LACTIC DEHYDROGENASE) REAGENT (K860729)Trace Scientific , Ltd.1986-04-07
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC) (K860731)Trace Scientific , Ltd.1986-04-07
KODAK AUTOMIXER II (K861225)Eastman Kodak Company1986-04-07
KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM (K855002)Eastman Kodak Company1986-04-07
BACSTOP FILTER IRRIGATION SUPPLY KIT (K860544)Staar Surgical Co.1986-04-04
URICHECK (K860905)Difco Laboratories, Inc.1986-04-04
AR-1600 AUTOMATIC REFRACTOR (K861062)Nidek, Inc.1986-04-04
KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022)Micro-Bio-Logics1986-04-04
MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI (K854833)Meditec, Inc.1986-04-04
PICOSCALE BLOOD CELL COUNTER, MODEL PS-5 (K860166)Diagnostic Technology, Inc.1986-04-04
36-101 XDS111 XENON DELIVERY/TRAP SYSTEM (K860504)Victoreen, Inc.1986-04-04
NIDEK KM-800 AUTO KERATOMETER (K861063)Nidek, Inc.1986-04-04
DONALDSON NATURAL EYEPATCH (K860979)Keeler Instruments, Inc.1986-04-04
SUPERLITE PENLIGHT (K861028)Keta Corp.1986-04-04
FILTRA-CHECK-UTI (K860483)Applied Polytechnology, Inc.1986-04-04
BAUSCH & LOMB LENS CARRYING CASE (K854968)Bausch & Lomb, Inc.1986-04-04
PB 254 IR - SPECTROMETER (K861213)Datex Division Instrumentarium Corp.1986-04-04
GUNKEL CHROMAGRAPH COLOR VISION TESTER (K860174)Chromagraphics, Inc.1986-04-04
AR-1000 AUTOMATIC REFRACTOR (K861066)Nidek, Inc.1986-04-04
UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER (K860185)Neuromed, Inc.1986-04-04
CLAMP-N-CUT (K860445)Mmi, Inc.1986-04-04
HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME (K860122)Medical Device Consultants, Inc.1986-04-04
SILENT PARTNER MODEL 10-1001 (K861012)Medical Devices, Inc.1986-04-04
MUREX SUDS GROUP A STREP (K860576)Murex Corp.1986-04-04
EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA (K853094)Psp Dental Co., Ltd.1986-04-04
DIGITAL-9 KEY LEUCOCYTE COUNTER (K854685)Future Impex Corp.1986-04-04
HONEYWELL ELECTRONIC VENTILATOR EV-A (K853501)Honeywell, Inc.1986-04-04
ASSERACHROM VWF KIT (K860371)American Bioproducts Co.1986-04-04
ABSORBENT, FIBER, OPERATING ROOM TOWELS (K860936)Ulti-Med Intl., Inc.1986-04-04
KULTSURE (CULTURE TRANSPORT) (K860178)Ncs Diagnostics, Inc.1986-04-04
SILENT PARTNER MODEL 10-2001 (K861011)Medical Devices, Inc.1986-04-04
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT (K860778)Hybritech, Inc.1986-04-04
VES-TEC/VES-MATIC (K854223)Marvic Interpharma, Inc.1986-04-04
KYOCERA BIOCERAM POROUS DENTAL IMPLANT (K860360)Kyocera International, Inc.1986-04-04
EYEMETER (K860928)Indivisual Corporation, Inc.1986-04-04
VIRTRAN VIRAL TRANSPORTER (MODIFIED) (K860967)Diagnon Corp.1986-04-04
KATALAVOX VOICE-ACTIVATED SWITCHING DEVICE (K855086)Kempf Co.1986-04-04
EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 (K860641)Em Diagnostic Systems, Inc.1986-04-03
PRECINORM IM AND PRECIPATH IM (K860970)Boehringer Mannheim Corp.1986-04-03
GILFORD UNIQUAL ABNORMAL CONTROL SERUM/UNASSAYED (K860998)Ciba Corning Diagnostics Corp.1986-04-03
A-GENT LIQUID TOTAL BILIRUBIN (K860424)Abbott Laboratories1986-04-03
GILFORD UNIQUAL NORMAL CONTROL SERUM/UNASSAYED (K861000)Ciba Corning Diagnostics Corp.1986-04-03
TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN (K860868)Technicon Instruments Corp.1986-04-03
A-GENT LIQUID TOTAL PROTEIN (K860426)Abbott Laboratories1986-04-03
VAN-TEC DEFLECTING GRASPING FORCEPS (K860268)Van-Tec, Inc.1986-04-03
ISOLIFE DISPENSING SYSTEM (K861051)Navaco Laboratories1986-04-03
A-GENT LIQUID CALCIUM (K860425)Abbott Laboratories1986-04-03
MARDIS DANGLER URETERAL STENT SET (K860267)Van-Tec, Inc.1986-04-03
PSP C & B TEMP (K853092)Psp Dental Co., Ltd.1986-04-03
ANALYTE IRON/TECHNICON CHEM 1 SYSTEM (K860799)Technicon Instruments Corp.1986-04-03
DAVIS LOOP STONE EXTRACTOR/URETERAL CATHETER (K860946)Van-Tec, Inc.1986-04-03
SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485)Sterling Diagnostics, Inc.1986-04-03
EASY-TEST AMLASE (AMYL), #67521/93 (K860918)Em Diagnostic Systems, Inc.1986-04-03
TI-FIT ACETABULAR COMPONENT (K860275)Richards Medical Co., Inc.1986-04-03
AUDIANT BONE CONDUCTOR OR A.B.C. (K855059)Xomed, Inc.1986-04-03
URIC ACID REAGNET SET (TRINDER) (K860477)Sterling Diagnostics, Inc.1986-04-03
ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET (K860667)Sterling Diagnostics, Inc.1986-04-03
SGOT (AST) REAGENT SET (K860216)Sterling Diagnostics, Inc.1986-04-03
DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID (K860671)Miracle-Ear/Dahlberg, Inc.1986-04-03
ULTRAPROX, INTERPROXIMAL TOOTHBRUSH (K860779)William J. Forni, D.D.S.1986-04-02
RIGHT ATRIAL CATHETER CATALOG NO. RAC - XXX SERIES (K860699)Intracath, Inc.1986-04-02
MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4 (K853216)Gyneco, Inc.1986-04-02
DISPOSABLE HEATED WIRE LOOPS 48 AND 72 (K860941)Intec Medical, Inc.1986-04-02
CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD (K861019)Phase One Disign Co.1986-04-02
ENDOSCOPE ACCESSORIES, CLEANING, FOR ENDOSCOPE (K860246)Buckman Co., Inc.1986-04-02
TRACHEOBRONCHIAL SUCTION CATHETER (K860802)Sheridan Catheter Corp.1986-04-02
STABLELINE (K860298)Cardio Metrics, Inc.1986-04-02
PLASTIC MOUTH BARRIER HCV-E (K860780)Westmark Enterprises, Inc.1986-04-02
BIOPSY ADAPTER H4222W (K861050)General Electric Co.1986-04-02
VISTA INTERFACE SYSSTEM (K860844)Vacumetrics, Inc.1986-04-02
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS (K861088)Bivona Medical Technologies1986-04-02
NARKOMED 3 ANESTHESIA SYSTEM (MODIFIED) (K861170)Draeger Medical, Inc.1986-04-01
ESOPHAGEAL STETHOSCOPE (K860558)Sharn, Inc.1986-04-01
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER (K861166)Victor1986-04-01
CONICAL COLLAR HIP PROSTHESIS POROUS COATED (K860002)Kirschner Medical Corp.1986-04-01
HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDS (K855150)Hpk International, Inc.1986-04-01
UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS) (K860535)Andover Medical, Inc.1986-04-01
MULTI-IMAGE CAMERA, SERIES 2100, MODEL #2100-06 (K860761)Lenzar Optics Corp.1986-04-01
MODULAR PRESS FIT (MPF) STEM (K855200)Depuy, Inc.1986-04-01
MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING (K860455)Oxford Medilog, Inc.1986-04-01
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Track 1986 automatically

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