Atlas FDA

1984

4,397 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MULHOLLAN ARTHROSCOPIC NEEDLE CARRIER (K834370)Acufex Microsurgical, Inc.1984-02-27
WILCOR-XR RP-OG MEDICAL FILM (K834612)Cea America Corp.1984-02-27
MYCOLOGICAL SELECTIVE MEDIUM (K840520)Scientific Device Laboratory, Inc.1984-02-27
PATIENT MONITOR 78534B (K840251)Hewlett-Packard Co.1984-02-27
SPOTTEST NITRATE REAGENT A (K840579)Difco Laboratories, Inc.1984-02-27
HEMOCCULT-C (K832311)Menley & James Laboratories1984-02-27
PBC IV SET NON-VENTED (K834253)Philadelphia Biologics Center1984-02-27
SURGICAL INSTRUMENTS & ACCESSORIES (K834366)C.B.S. Biotechnics, Inc.1984-02-27
VACUUM STRETCHER IMMOBILIZER (K840034)Medicon, Inc.1984-02-27
SPOTTEST NITRATE REAGENT B (K840580)Difco Laboratories, Inc.1984-02-27
SPOTTEST OXIDASE REAGENT (K840575)Difco Laboratories, Inc.1984-02-27
CHILDREN'S WHEELCHAIRS (K840636)Poirier S.A.1984-02-27
PBC EXTENSION SET (K834252)Philadelphia Biologics Center1984-02-27
VERTICALIBRE WHEELCHAIR (K840626)Poirier S.A.1984-02-27
DISCRETE CLINICAL ANALYZER (K834521)E.I. Dupont DE Nemours & Co., Inc.1984-02-27
VIRAL TRANSPORT MEDIUM (K840851)Bartels Immunodiagnostic Supplies, Inc.1984-02-24
CONTINUOUS EPIDURAL ANESTHES. TRAY (K840179)Burron Medical Products, Inc.1984-02-24
H.R. JAKOBI SURG. INSTR. #10 34/36 (K834178)Imm Enterprises , Ltd.1984-02-23
IMPULSE VENTILATOR (K840345)Healthdyne, Inc.1984-02-23
CAT 10-NEUROLOGY DEVICE (K840314)Imm Enterprises , Ltd.1984-02-23
BRACHIAL PLEXUS ANESTHESIA TRAY (K840287)Burron Medical Products, Inc.1984-02-23
OP-CON SURG. INSTRUMENT #10 (K834170)Imm Enterprises , Ltd.1984-02-23
NITROGLYCERIN I.V. ADMINISTRATION SET (K833939)Critikon Company, LLC1984-02-21
ISOREX LS-36 (K834496)Elscint, Inc.1984-02-21
FLOW-PAC CALCIUM REAGENT SET (K834336)American Research Products Co.1984-02-21
HEMASITE ACCESSORIES MODIFICATION (K840437)Renal Systems, Inc.1984-02-21
TECHNICARE MODEL 1047 (K840390)Technicare Corp.1984-02-21
DISPOS. ANESTHESIA FACE MASK (K840535)Marquest Medical Products, Inc.1984-02-21
CAL-CHEX, A HEMATOLOGY CALIBRATOR (K840261)Streck Laboratories, Inc.1984-02-21
STERILE INSULIN DISPOS. NEEDLE/GREEN (K840083)Lee Medical Intl., Inc.1984-02-21
DISPOSABLE I/A HANDPIECE (K833784)CooperVision, Inc.1984-02-21
X-RAY COLLIMATOR X-CJD (K834606)Knochen Dental Laboratory1984-02-21
SPECTRUM X-RAY CORP (K834494)Spectrum X-Ray Corp.1984-02-21
ARTICULATING PAPER (K832647)Ardent Intl., Inc.1984-02-21
FLOW-PAC CHLORIDE REAGENT SET (K834333)American Research Products Co.1984-02-21
SEP PROGRAMMER SEP-M/SINGLE-PLANE & (K840389)Elema-Schonander, Inc.1984-02-21
COMPUTED TOMOGRAPHY CALIBRATION PHANT (K840131)Imatron, Inc.1984-02-21
MODEL 2001 INTELLIGENT INFUSOR (K834528)Quest Medical, Inc.1984-02-21
POST-AURICULAR HEARING AID (K840359)Phonic Ear, Inc.1984-02-21
CRONEX SR-337 (K834484)E.I. Dupont DE Nemours & Co., Inc.1984-02-21
BIOREM 3000 & 4000 (K833454)Biorem1984-02-21
LEECO T3-QUANT DIAG. KIT (K834348)Leeco Diagnostics, Inc.1984-02-21
EXTENDED LIFE CAPD SOLUTION TRANSFER (K840224)Travenol Laboratories, S.A.1984-02-21
CROWN & BRIDGE RESIN (K834435)Rohm and Haas Co.1984-02-21
DELUXE WALL-MOUNTED CEPHALOMETER (K834559)Knochen Dental Laboratory1984-02-21
SANDMILL RMS (K834512)Sandhill Scientific, Inc.1984-02-21
PRE-CALIBRATED PIPETTES (K834100)Vitex1984-02-21
OMYL -ARDE- SPECTACLE FRAME (K833401)I.J. Langleb , Ltd.1984-02-21
INSTRUMENT, DENTAL (K834072)Venture Technology, Inc.1984-02-21
SEDIPLAST (K840500)Precision Technology, Inc.1984-02-21
ULTRASOUND SCANNER XL (K834307)Interad Systems, Inc.1984-02-21
SINGUL-XR RP NON SCREEN MED. FILM (K834611)Cea America Corp.1984-02-21
VANADIUM EXCAVATORS SIZES 0-6 (K834055)Henry Schein, Inc.1984-02-21
DIGITAL AUDIOMETER/HEARING AID 3100 (K833883)Frye Electronics, Inc.1984-02-21
COUNTER MODEL S880 (K840128)Coulter Electronics, Inc.1984-02-21
DIRECT IRON REAGENT SET (K834396)Seragen Diagnostics, Inc.1984-02-21
IV ADMINISTRATION SET (K840081)Lee Medical Intl., Inc.1984-02-21
PROFILE URODYNAMIC MONITORING SYS (K834503)Browne Medical, Inc.1984-02-21
HEMASITE/RENALOY -VASCULAR ACCESS SHUNT (K840436)Renal Systems, Inc.1984-02-21
FLEXIBLE LIQUID LIGHT GUIDE (K834487)Endo Lase, Inc.1984-02-21
CURAY-MATCH PAINT-ON COMPOSITE RESTOR (K833810)Scientific Pharmaceuticals, Inc.1984-02-21
STERILE INSULIN DISPOS. NEEDLE/SYRINGE (K840082)Lee Medical Intl., Inc.1984-02-21
MALE INSERT SLIP (K840482)Beghin_Say Intl., Inc.1984-02-21
CHICK/REISON PATIENT EMERG. TROLLEY (K834478)Professional Medical Products, Inc.1984-02-21
SERIES OF DIAGNOSTIC PHANTOMS (K834465)Cirs, Inc.1984-02-21
ELECTRONIC KVP CASSETTE (K834607)Radiation Measurements, Inc.1984-02-21
HYBRITECH DATA STATION (K834300)Hybritech, Inc.1984-02-21
DIGITAL CRADLE (K840463)Spectrum X-Ray Corp.1984-02-21
LAS-2 ALIGNMENT SYSTEM (K834538)Therados, Inc.1984-02-21
KC 100 M (K834285)Elscint, Inc.1984-02-17
SIGMA 20 ELECTRONIC SECTOR SCANNER (K833680)Kontron Instruments, Inc.1984-02-17
SPECIMEN TRAP (K834467)Microvasive1984-02-17
INSTRUMENT TIP PROTECTION COVERS (K834127)Devon Industries, Inc.1984-02-17
IMPROVED MOUTHPIECE (K840459)Kinetix1984-02-17
MOD 456 (K834276)Hoffrel Instruments, Inc.1984-02-17
EMCO WHEELCHAIR (K840478)Emco Medical Supply1984-02-17
PREMIUM DABM DISPOS. ANES. BREATH MASK (K840452)Ohio Medical Products1984-02-17
OXYGEN ANALYZER 200 (K840361)Salter Labs1984-02-17
RADIOPAQUE 7 FRX 12-POLYURETHANE MULTI (K840336)Arrow Intl., Inc.1984-02-17
MACCONKEY AGAR W/TWEEN 80 & AMPICIL (K840190)Remel Co.1984-02-17
FLORET FOAM PREP SPONGE (K833626)Ritmed, Inc.1984-02-17
PMT-HALO/ORTHOPEDIC JACKET SYSTEM (K834047)Progress Mankind Technology1984-02-17
GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD (K840294)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-02-17
SOLUTION TRANSFER SET (K834500)Berlex Laboratories, Inc.1984-02-17
MEMORY LOOP TRANSMITTER #121 (K832951)Biometric Products, Inc.1984-02-17
SSA HIP PROSTHESIS (K840357)Dow Corning Corp. Healthcare Industries Materials1984-02-17
INSPIRATORY/EXPIRATORY MUSCLE EXERCIS (K840418)Inspiron Corp.1984-02-17
MOD 427 (K834277)Hoffrel Instruments, Inc.1984-02-17
PAPANICOLAOU STAIN SYS HT40 (K840054)Sigma Chemical Co.1984-02-17
RESPIRODYNE PULMONARY FUNCTION TEST (K834475)Chesebrough-Pond'S U.S.A. Co.1984-02-17
CARDIOPLEGIA HEAT EXCHANGER HOLDER (K840256)American Bentley1984-02-17
NEUROMUSCULAR STIMULATOR 3105 (K840467)Medtronic Vascular1984-02-17
QUICK-COUNT HEMATOLOGY REAGENT KIT (K833972)Seragen Diagnostics, Inc.1984-02-17
NEUROMUSCULAR TRANSMISSION MONITOR (K840108)Datex Division Instrumentarium Corp.1984-02-17
VESSEL DILATOR (K840641)Aries Medical, Inc.1984-02-14
TRIPLE LUMEN INFUSIONCATHETERS- (K834615)Medical Components, Inc.1984-02-14
CLOUTIER II FIBER METAL TOTAL KNEE (K833363)Zimmer, Inc.1984-02-13
DESERET NEONATAL CATHETER SET (K834393)Parke-Davis Co.1984-02-13
MODEL 1888 ALPHA COS/RESPIRATION CAR (K834460)Spacelabs, Inc.1984-02-13
CARDIOVASCULAR SPRING GUIDE WIRE (K834223)Mallinckrodt Critical Care1984-02-13
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Every clearance here is in the API, with alerts when new ones post.