Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CERTI-FORM (K854001)Beltone Electronics Corp.1985-12-31
AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B (K854043)Teledyne Avionics Div. of Teledyne1985-12-31
SARATOGA SCT HEATED HUMIDIFICATION SYSTEM (K854363)Saratoga Medical Instrumentation, Inc.1985-12-31
DIASONICS ADA400 ADVANCED DIGITAL ARRAY (K851972)Diasonics, Inc.1985-12-31
CSM MEDIUM (K854052)Northern Scientific, Inc.1985-12-31
EKG 503A (K840571)Bosch Hearing Instruments, Inc.1985-12-30
THE NEW MCINTYRE I.A. HANDPIECE (K854402)Microsurgical Technology, Inc.1985-12-30
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175 (K852459)Healthteam1985-12-30
SERIES 25 SLIMLINE CRYO PROBES (K854422)Keeler Instruments, Inc.1985-12-30
OSM3 HEMOXIMETER (K853990)Radiometer America, Inc.1985-12-30
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115 (K852653)Healthteam1985-12-30
VIRATEK SMALL PARTICLE AEROSOL GENERAT (K843717)Viratek, Inc.1985-12-30
EKG 501 A (K840569)Bosch Hearing Instruments, Inc.1985-12-30
DART CK-MB REAGENT SYSTEM (K854708)Coulter Electronics, Inc.1985-12-30
RAMP URINE HCG ASSAY (K854611)Monoclonal Antibodies, Inc.1985-12-30
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165 (K852457)Healthteam1985-12-30
THE NEW MOBILE TIP MCINTYRE CANNULA (K854401)Microsurgical Technology, Inc.1985-12-30
HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145 (K852458)Healthteam1985-12-30
QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES (K853217)Quantum Medical Systems, Inc.1985-12-30
KEELER-COMPACT CRYO SYSTEM (K854411)Keeler Instruments, Inc.1985-12-30
PERI-GUARD PERICARDIAL PATCH (K842066)Genetic Laboratories, Inc.1985-12-30
LECTROSTILL DISTILLED WATER U.S.P. (K854764)Electrified Companies, Inc.1985-12-30
AMERICAN STERILE SURGICAL ABSORBENT TOWEL (K854739)American Hospital Supply Corp.1985-12-27
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR (K854375)CooperVision, Inc.1985-12-27
HI-TECH LAB MODEL CONCHA ALL IN EAR (K853967)Hi-Tech Laboratories, Inc.1985-12-27
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS (K854225)Advanced Medical Technology, Inc.1985-12-27
GRESCO N.P. DENTAL ALLOY (K854495)Gresco Products, Inc.1985-12-27
VICON (MODIFICATION) (K853804)Oxford Metrics, Inc.1985-12-27
LINK CORTICAL SCREWS (K854827)Link America, Inc.1985-12-27
LINK CANCELLOUS SCREWS (K854826)Link America, Inc.1985-12-27
EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS (K852178)American Omni Medical, Inc.1985-12-27
MODULAR POWER BASE (K854051)Everest & Jennings, Inc.1985-12-27
SPECULITE DISPOSABLE VAGINAL LIGHT (K853257)Trylon Associates, Ltd.1985-12-27
PLACIDO DISC (K854054)Cutler Medical Instruments1985-12-27
HYBRID POINTS (K854347)Shofu Dental Corp.1985-12-27
PHACO PACKS, 1A PACKS & PACK COMPONENTS (K854116)Medical Corp. of America1985-12-27
P.M. HIP-FEMORAL PROSTHESIS (K853916)Advanced Biosearch Assn.1985-12-27
MARATHON POWER DRIVE-WHEELCHAIR (K854153)Everest & Jennings, Inc.1985-12-27
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS (K854657)Cordis Corp.1985-12-27
BARD PARKER THORACIC VENT (K854634)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-12-27
MODEL M HEARING AID (K852656)Magnatone Hearing Aid Corp.1985-12-27
SATALEC SERVOTOME (K852522)Spelna, Inc.1985-12-27
GDC 1453 CASTING ALLOY (K854285)Deringer-Ney, Inc.1985-12-27
BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (K854147)Battle Creek Equipment Co.1985-12-27
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (K854490)American Micro Scan1985-12-27
IN VITRO TEST DETERMINATION OF SGPT(ALT) (K854186)Clinical Data, Inc.1985-12-25
SCALPEL, ONE-PIECE, DISPOSABLE (K854857)Medelec Intl. Corp.1985-12-24
BLADES, SCALPEL STAINLESS STEEL (K854859)Medelec Intl. Corp.1985-12-24
MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (K854262)Meadox Surgimed, Inc.1985-12-24
RULER (K854892)Euro-Med Intl.1985-12-24
KEYES SKIN PUNCH (K854893)Euro-Med Intl.1985-12-24
VENTILATOR PRESSURE ALARM MODEL VPA-100 (K854934)Respiratory Support Products, Inc.1985-12-24
SCALPEL HANDLE (K854858)Medelec Intl. Corp.1985-12-24
MCGHAN INTEGRAL VALVE TISSUE EXPANDER (K854794)Mcghan Medical Corp.1985-12-24
VITALOGRAPH COMPACT (K854526)Vitalograph , Ltd.1985-12-24
MEDTRONIC PERMANENT LEAD INTRODUCER (K854559)Medtronic Vascular1985-12-24
BI-POLAR FORCEPS (K854864)Birtcher Corp.1985-12-24
RANDALL CURETTE (K854888)Euro-Med Intl.1985-12-24
LPA-1 PRESSURE MONITOR (K854022)Life Products, Inc.1985-12-24
BLADES, SCALPEL CARBON STEET (K854860)Medelec Intl. Corp.1985-12-24
EPISIOTOMY SCISSORS (K854900)Euro-Med Intl.1985-12-24
NOVAK CURETTE (K854899)Euro-Med Intl.1985-12-24
HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A (K854135)Hewlett-Packard Co.1985-12-23
CRITIC C LEVEL I & II (K853943)Dimension Diagnostics1985-12-23
TRITON LAPAROSCOPIC COAGULATOR INSUFFLATOR & LAVAG (K852680)Multigon Industries, Inc.1985-12-23
DIRECT ELISA FOR HERPES SIMPLEX VIRUS (K853307)Fairleigh Dickinson Laboratories, Inc.1985-12-23
SHAH SELF-CLEARING MASTOID SUCTION TUBE (K853589)Downs Surgical , Ltd.1985-12-23
BIOGRAM (K854521)Giles Scientific, Inc.1985-12-23
EPIDURAL ANESTHESIA TRAY (K854518)Omnis Surgical, Inc.1985-12-23
MICRO-MAT SYSTEM (K854962)Ulster Scientific, Inc.1985-12-23
CERAM-ETCH (K854494)Gresco Products, Inc.1985-12-23
TRANSPORT CULTURE MEDIA (K854715)Hillcrest Biologicals1985-12-23
TENS (K850006)Zimmer Elektromedizin GmbH1985-12-20
SUBDERM TM (K853635)General Medical Co.1985-12-20
AUDTEX 85 (K853895)Cami, Inc.1985-12-20
NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (K854718)Nobel Scientific Industries, Inc.1985-12-19
BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY (K854919)Cook Pacemaker Corp.1985-12-19
QUANTTEST TOTAL PROTEIN ASSAY (K853932)Quantimetrix Corp.1985-12-19
DSL ACTIVE TESTOSTERONE RIA (DSL #4000) (K854671)Diagnostic Systems Laboratories, Inc.1985-12-19
IN VITRO TEST DETERMINATION OF THEOPHYLLINE (K854183)Clinical Data, Inc.1985-12-19
THE HOOD LIFE SAVER (K853511)Hood Laboratories1985-12-19
MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA (K854550)Medipart Jerry Alexander1985-12-19
O.M.S. ULTRA-PHACO (K844373)Optical Micro Systems, Inc.1985-12-19
ABSORBANCE (ABS) TEST PAK (K854784)Diagnostic Systems1985-12-19
MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S (K854551)Medipart Jerry Alexander1985-12-19
LONG TERM PERITONEAL CATHETER (K854614)Thermadics, Inc.1985-12-19
EPIDURAL ANESTHESIA NEEDLES (K854816)Reganes, Inc.1985-12-19
DSL ANDROSTENDIONE RIA (DSL #4200) (K854674)Diagnostic Systems Laboratories, Inc.1985-12-19
ARI STANDARD ANESTHESIA RECORD (K854213)Agilent Technologies, Inc.1985-12-19
5.0 MHZ INTRACAVITARY SECTOR PROBE (K853711)General Electric Co.1985-12-18
MA25 PORTABLE AUDIOMETER (K853919)Maico Hearing Instruments, Inc.1985-12-18
INFUSAID INFUSE-A-PORT (MODIFIED) (K853981)Intermedics/Infusaid, Inc.1985-12-18
INT'L MODEL XE BEHIND-THE-EAR HEARING AID (K853942)Int'L Hearing Aids, Inc.1985-12-18
DEN-MAT PAINT-ON RUBBER DAM (K852630)Den-Mat Corp.1985-12-18
MODEL 310 IMPEDANCE SYSTEM (K853863)Virtual Corp.1985-12-18
INT'L MODEL XG BEHIND-THE-EAR HEARING AID (K853941)Int'L Hearing Aids, Inc.1985-12-18
FIBRELIGHT NASAL SPECULA (K853588)Downs Surgical , Ltd.1985-12-18
BRONCHIAL CYTOLOGY BRUSH (K853667)E-Z-Em, Inc.1985-12-18
BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (K854148)Battle Creek Equipment Co.1985-12-17
OVUTIME OVULATION PREDICTOR TEST (K853142)Advanced Care Products1985-12-17
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Track 1985 automatically

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