Atlas FDA

1986

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

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RecordFirmDate
MEDSURG CUSTOM SURGICAL SCRUB TRAYS (K864463)Medsurg Industries, Inc.1986-12-17
ELECTROPHORESIS DATA CENTER (EDC) (K860645)Helena Laboratories1986-12-17
SUNFIT SUNLAMP (K864485)Sunfit, Inc.1986-12-17
HOSPAL BIOSPAL 1800S (K863961)Hospal Medical Corp.1986-12-17
ADOBE ENTERPRISES SURGICAL/BANDAGE SCISSORS FORCEP (K864608)Adobe Ent.1986-12-16
OEC DESIGN ORTHOPEDIC CAST HEEL (K864092)Military Engineering, Inc.1986-12-16
KOKEN'S NEW MODEL M-3000 POWER TABLE (K864501)Koken Mfg Company, Inc.1986-12-16
UBI MAGIWEL(TM) TSH QUANTITATIVE (K864079)United Biotech, Inc.1986-12-16
LOW VOLUME EXTENSION SET (K864395)Panamedix, Inc.1986-12-16
NAPHTHYL PHOSPHATE, ACID PHOSPHATASE (K863832)Pointe Scientific, Inc.,1986-12-16
ELECTRIFIED TRANSFER TOILET SEAT (K864324)Robert E. Roy1986-12-16
DSL-4800 ACTIVE TM TSH EIA SYSTEM (K864134)Diagnostic Systems Laboratories, Inc.1986-12-16
WAKO(TM) GOT II - HA (K864302)Wako Chemicals USA, Inc.1986-12-16
IQ T4 IMMUNOASSAY (K864560)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
JEJUNAL FEEDING TUBE (K861309)Microvasive1986-12-16
ROTATION AIR FLUIDIZED BED/DELTA (K864232)Kinetic Concepts, Inc.1986-12-16
UBI MAGIWEL(TM) PROLACTIN QUANTATIVE (K864075)United Biotech, Inc.1986-12-16
IQ URIC ACID TEST (K864341)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
LAPORATOMY SPONGES SIZES:18X18,12X12,4X18,8X36 (K864529)Elof Hansson, Inc.1986-12-16
IQ TRIGLYCERIDES (K864268)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-16
SEGMENTAL SPINAL INSTRUMENTATION SYSTEM (K864337)Kirschner Medical Corp.1986-12-16
CIBA CORNING MAGIC(R) LITE TU IMMUNOASSAY (K864132)Ciba Corning Diagnostics Corp.1986-12-16
SCOOTA MOTORIZED VEHICLE (K864686)A-Bec Mobility, Inc.1986-12-16
REPLACEMENT GASTROSTOMY TUBE (K861323)Microvasive1986-12-16
3M GLASS IONOMER LINER (K864270)3M Company1986-12-16
MODIFIED DUAL LUMEN NEEDLE (K864629)Quinton, Inc.1986-12-16
USI AUTOJECT INSULIN SYRINGE (K864761)Ulster Scientific, Inc.1986-12-16
COMFORT+LIFT CHAIR (K864366)Invacare Corp.1986-12-16
I.V. START KITS (K864693)Salt Creek Medical Technologies1986-12-16
ALT WHEELCHAIR (K864573)Alt Design1986-12-16
WAKO GPT II - HA (K864335)Wako Chemicals USA, Inc.1986-12-16
CRIS ADAPTED WITH VOLUME LIMITING BAG (K864164)Y1986-12-16
ENTHERMO IRRIGATION UNIT (K863615)Jedmed Instrument Co.1986-12-16
STA-SET MODEL 250 I.V. FLOW REGULATOR (K864229)Sta-Set Corp.1986-12-16
TDX(R) II ANALYZER (K864319)Abbott Laboratories1986-12-16
OHMEDA 7400 ANESTHESIA VENTILATOR (K864129)Ohmeda Medical1986-12-16
VISION(TM) AMYLASE (K864435)Abbott Laboratories1986-12-16
ACTIVE LIGHTWEIGHT WHEELCHAIR (K864684)A-Bec Mobility, Inc.1986-12-16
OPEN RESERVOIR SCAVENGER (K864034)Draeger Medical, Inc.1986-12-15
ANTI-NDNA ANTIBODY TEST KIT (K864275)Cappel Diagnostics, Inc.1986-12-15
MULTISPIRO SA/100 (K863134)Biotrine Corp.1986-12-15
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (K863743)Immuno Nuclear Corp.1986-12-15
VES-10 INTRAOCULAR SCISSORS DRIVE (K864035)Trek Medical Products, Inc.1986-12-15
VIS-CUBE HCG (EIA) (K863933)Leeco Diagnostics, Inc.1986-12-15
BIRD NIGHTBIRD NASAL CPAP SYSTEM (K863746)Bird Products Corp.1986-12-15
PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (K863978)Penox Technologies, Inc.1986-12-15
LEG HOLDER (K864476)American Container Technology, Inc.1986-12-15
ESOPHAGEAL STETHOSCOPE W/THERMOCOUPLE TYPE T (K864043)Respiratory Support Products, Inc.1986-12-15
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE (K864290)Keeler Instruments, Inc.1986-12-15
NO-FLO I (K863613)Design Technologies, Inc.1986-12-15
HENSON - HAMBLIN CFS 2000 CENTRAL FIELD SCREEN (K864467)Keeler Instruments, Inc.1986-12-15
CANCELLOUS BONE SCREW (K864626)Dow Corning Wright1986-12-15
MODEL 6500 OPTHALMIC CHAIR (K864494)Koken Mfg Company, Inc.1986-12-15
PORTA RAY MODEL 325 (K864339)Porta Ray, Inc.1986-12-15
LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER (K864369)Heidelberg Instruments1986-12-15
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD) (K864301)Site Microsurgical Systems, Inc.1986-12-15
FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM (K861692)Fischer Imaging Corp.1986-12-15
EMERSON 3MV VOLUME VENTILATOR (K864379)J. H. Emerson Co.1986-12-15
MAC 150E OPTHALMIC CHAIR (K864574)Koken Mfg Company, Inc.1986-12-15
BKS-42 DISPOSABLE VACUUM TUBING PACK (K864065)Allergan, Inc.1986-12-15
YANNUZZI FUNDUS LASER LENS (K864304)Ocular Instruments, Inc.1986-12-15
ARTHROSCOPIC SHOULDER LIGAMENT REPAIR KIT (K862017)Dyonics, Inc.1986-12-15
MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS (K863667)Depuy, Inc.1986-12-12
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS (K864517)Medtronic Minimed1986-12-12
STERILABELS (K864015)Diversatronics, Inc.1986-12-12
SYPH-TRUST (K863368)I.A.F. Production, Inc.1986-12-12
IRAS PERIMETER (K864012)Randwal Instrument Co., Inc.1986-12-12
CREATINKINETIC (K863079)J. D. Assoc.1986-12-12
EUB-400 DIAGNOSTIC ULTRASOUND DEVICE (K863576)Hitachi Medical Corp. of America1986-12-12
RAYLOR(TM) DISSECTING HOOK (K864425)Cedar Surgical, Inc.1986-12-12
MAINSTER RETINA LASER LENS (K863911)Ocular Instruments, Inc.1986-12-12
ABBOTT LIFECARE(R) 4100 PCA INFUSER (K863997)Abbott Laboratories1986-12-12
BIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTR (K864179)Ash Medical Systems, Inc.1986-12-11
MAKLER CATHETER (K863785)I M, Inc.1986-12-11
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE (K862153)Arrow Intl., Inc.1986-12-11
MODIFIED VSM 2 VITAL SIGNS MONITOR (K864665)Physio-Control Corp.1986-12-11
MODIFIED SARNS MEMBRANE OXYGENATOR (K863902)3M Health Care, Sarns1986-12-11
NORFLOXACIN SUSCEPTIBILITY POWDER (K864442)Merck, Sharp & Dohme1986-12-11
DYMAX PERSONAL SCANNER (K862127)Dymax Corp1986-12-11
INTRAUTERINE CATHETER (K861305)Ram Development1986-12-11
BBL CAMPYSLIDE(TM) TEST (K864027)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-12-11
STOCKERT-SHILEY CAPS BATTERY MODULE (K863960)Shiley, Inc.1986-12-11
KOTEX (R) GOODNITES (K864187)Kimberly-Clark Corp.1986-12-11
MODIFIED LIFESTAT 200 (K864666)Physio-Control Corp.1986-12-11
LDH S.C.E. (K863068)J. D. Assoc.1986-12-10
TUBULICID RED LABEL (K864051)Dental Dimensions Supply Co.1986-12-10
MODIFIED SODIUM ELECTRODE (K863907)Ionetics, Inc.1986-12-10
PHARMACOKINETICS SOFTWARE SYSTEM (PPS) (K864121)Pharmatrol, Inc.1986-12-10
ALT S.C.E. (GPT) (K863053)J. D. Assoc.1986-12-10
NEOS-M VS-1 PULSE GENERATOR (K863879)Biotronik Sales, Inc.1986-12-10
SEA MED MODEL 6000 (K863903)Seamed Corp.1986-12-10
PROTEINMETER (K863112)J. D. Assoc.1986-12-10
MODEL 456 ELECTROCARDIORECORDER RECORDER (K863652)Del Mar Avionics1986-12-10
TRIOS-M VS-1 PULSE GENERATOR (K863878)Biotronik Sales, Inc.1986-12-10
Q-SCAN II AND Q-SCAN III (K864149)Quinton, Inc.1986-12-10
HEMOCCULT WIPE TEST (K862849)Smithkline Diagnostics, Inc.1986-12-09
HOWSE II TOTAL HIP REPLACEMENT SYSTEM (K864508)Johnson & Johnson Professionals, Inc.1986-12-09
MODEL HSE-5M MICROWAVE SURGERY EQUIPMENT/MICROTAZE (K864413)Cooper Lasersonics, Inc.1986-12-09
LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM (K864381)Luxtec Corp.1986-12-09
CYTOTECH HSV IGG ENZYME IMMUNOASSAY (K862838)Cytotech, Inc.1986-12-09
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Track 1986 automatically

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