Atlas FDA

1978

1,975 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BRUSH, APPLICATOR (K781098)3M Company1978-09-29
SOFT SILICONE ELASTOMER SPONGE EXPLANT (K780987)Medical Instrument Research Assoc., Inc.1978-09-28
EMIT MCA PROGRAM TAPE (K781081)Instrumentation Laboratory CO1978-09-27
PM 2000 AUTOMATIC PATIENT CHAIR (K781597)Time Motion System Co.1978-09-27
GENERATORS: UDL-201B, BDL-201B, MDL-201B (K781424)Pacesetter Systems1978-09-27
IPPB ASSEMBLY W/NEBULIZER (K781232)Rtec1978-09-27
IMMO PHASE, THYROID HORMONE (K781409)Corning Medical & Scientific1978-09-27
THREADED ROD CLAMP (K781447)Orthopedic Equipment Co., Inc.1978-09-27
PULSED AND CONTINUOUS SHORTWAVE APPAR. (K781316)General Theraphysical, Inc.1978-09-27
FLAT WRENCH (K781451)Orthopedic Equipment Co., Inc.1978-09-27
BODY-WORN HEARING AID, MODEL 787PP (K781595)Danavox, Inc.1978-09-27
TONOMETER, DIGITON (K781105)Ical, Inc.1978-09-27
PLASTI-PORE SEPTAL BUTTON (K781574)Richard'S Medical Equip., Inc.1978-09-27
ORTHO*T-3 UPTAKE KIT (K781482)Ortho Diagnostics, Inc.1978-09-27
STIMULATOR, NERVE, TRANSCUTANEOUS (K781277)Psitron1978-09-27
RESURFACE PROSHESIS (K781343)Aesculap Instruments Corp.1978-09-27
PULMO-SONIC (K781073)The Devilbiss Co.1978-09-27
MS-2 BACTERIAL ID. SYSTEM (K781427)Abbott Laboratories1978-09-27
ERM-101 (K781407)Cynergy1978-09-27
PRO-MOLD, CUSTOM EAR (K781491)Mcghan Medical Corp.1978-09-27
HARRINGTON SPINAL ELEVATOR (K781449)Orthopedic Equipment Co., Inc.1978-09-27
AIR BUBBLE DETECTOR (K781021)3M Health Care, Sarns1978-09-27
TECHNICON STAT/LYTE ISE ELECTROLYTE (K781503)Technicon Instruments Corp.1978-09-27
DISPOSABLE CARDIOTOMY; H-700F, H-700 (K781577)C.R. Bard, Inc.1978-09-27
SHORTWAVE THERAPY APPAR. CURAMED 401 (K781320)General Theraphysical, Inc.1978-09-27
MVS-MODEL SEU-6, DEU-6 (K781488)Dentsply Intl.1978-09-27
ORTHO*T-3 RIA (PEG) KIT (K781481)Ortho Diagnostics, Inc.1978-09-27
CENTRAL PEG TIBIAL COMPONENT (K781608)Howmedica Corp.1978-09-27
MARKII VENTIMASKS (K781325)Vickers America Medical Corp.1978-09-27
STERI-VAC POWER UNITS (K781486)Cpac, Inc.1978-09-27
MITROPHENYL, ALKALINE PHOSPHATES (K781472)Beckman Instruments, Inc.1978-09-27
HEARING AID, MODEL 775 PP/AGC (K781596)Danavox, Inc.1978-09-27
GENERATOR, PULSE, MODEL 160B (K780940)Telectronics, Inc.1978-09-27
DRIVERS (K781450)Orthopedic Equipment Co., Inc.1978-09-27
C RING CLINCHER (K781446)Orthopedic Equipment Co., Inc.1978-09-27
HARRINGTON HOOK CLAMP (K781448)Orthopedic Equipment Co., Inc.1978-09-27
RIALYZE VITAMIN B-12 TEST (K781410)Ames Div., Miles Laboratories, Inc.1978-09-27
TEST SYSTEM TISSUE CELL CULTURE SLIDE (K781516)Zeus Scientific, Inc.1978-09-27
OUTRIGGER DISTRACTION UNIT (K781444)Orthopedic Equipment Co., Inc.1978-09-27
COULTER ELECTROLYTE ANALYZER SYSTEM (K781528)Coulter Electronics, Inc.1978-09-27
SPECTRASCAN (K781103)Medishield, Inc.1978-09-27
PACEMAKER, MODEL 225 & 227 (K772226)Intermedics, Inc.1978-09-27
ORTHO*T-4 RIA (PEG) KIT (K781483)Ortho Diagnostics, Inc.1978-09-27
INTERFACE CARDIOTOMY BLOOD FILTER (K781383)Medical, Inc.1978-09-27
HARRINGTON SPINE INSTRUMENTATION (K781443)Orthopedic Equipment Co., Inc.1978-09-27
MODEL 80032A, OBSTETRICAL TELEMETRY (K781359)Hewlett-Packard Co.1978-09-26
WATERPATH SCANNING OPTION (K781508)G.D. Searle and Co.1978-09-26
ZEE-FRAME (K781509)Equilibrated Bio Systems, Inc.1978-09-26
FLOMETER (K781541)Chemetron Medical Products, Inc.1978-09-26
MUSCLE STIMULATOR, ELECTRONIC (K781139)Thor Medical Instruments, Inc.1978-09-26
DLC 500, DOUBLE LUMEN CATHETER (K781050)Hemodialysis, Division of The1978-09-26
MUSCLE STIMULATOR, ELECTRICAL (K781113)Rich-Mar Corp.1978-09-26
ELECTRODE, DEIP. (K781163)Datascope Corp.1978-09-26
CATHODE RAY TUBE MED. DISPLAY (K781256)Rae Medical Corp.1978-09-20
MICROSURGICAL KNIVES, 20, 30, 45 (K781465)Codman & Shurtleff, Inc.1978-09-20
T.E.D. SEQUENTIAL COMPRESSION SLEEVES (K781357)Kendall Research Center1978-09-20
INSTA-PULSE HEART RATE MONITOR (K781387)Bio Sig Instruments, Inc.1978-09-20
LUNG EXER. BAG, POST-OP, MODIFIED (K781245)Dytek Corp.1978-09-20
STIMULATOR, NERVE, TRANSCUTANEOUS (K781157)Medtech Intl., Inc.1978-09-20
CORNEAL CUTTER AND ACCESSORIES (K781411)Codman & Shurtleff, Inc.1978-09-20
SILASTIC U-TUBE KIT (K781526)Dow Corning Corp. Healthcare Industries Materials1978-09-20
CONNECTING TUBE, CONDUCTIVE, SURG. (K781127)Seamless Hospital Products Co.1978-09-20
CARDIOPNEUMOGRAPH (K781292)Street Electronics Corp.1978-09-20
BONE MARROW ASPIRATION KIT (K781371)Ferris Mfg. Corp.1978-09-20
OSTOMY APPLIANCE W/DEODORIZING FILTER (K781373)Hollister, Inc.1978-09-20
LINDE OXYGEN CONCENTRATOR MODEL LOC-HCA (K781454)Union Carbide Corp.1978-09-20
FOLEY CATHETERS (K781457)Intermed, Inc.1978-09-20
TILLMAN HIPSURFACE REPLACEMENT (K781490)Waldemar Link GmbH & Co. KG1978-09-20
TECA MODEL B9 ELECTROMYOGRAPH (K781399)Teca, Inc.1978-09-20
BIOSCAN E12 (K781421)Clinifax Industries, Ltd.1978-09-20
HEMOVAC TUBING MATERIAL CHANGE (K781400)Snyder Laboratories, Inc.1978-09-20
COMFORM ABSORBANT INCONTINENCE PADS (K781375)Kimberly-Clark Corp.1978-09-20
MERCURY DISP. CAPSULE (K781243)Lee Pharmaceuticals1978-09-20
PAB CONVENIENCE TRAY (K781264)Waters Assoc., Inc.1978-09-20
SEQUENTIAL CUFF INFLATION DEVICE (K781358)Medasonics, Inc.1978-09-20
PRECISION GAS MIXER (K781417)Medicor USA , Ltd.1978-09-20
DIGITAL PANEL METER (K781255)Rae Medical Corp.1978-09-20
MS-2 AUTOMATED URINE SCREENING SYSTEM (K781370)Abbott Laboratories1978-09-20
AC ADAPTER:MODELS 9525,9526,9527 (K781535)Edwards Laboratories1978-09-15
CEA-IMMERSIBLE SEPARATOR (K781043)Millipore Corp.1978-09-15
STEMPLEX (K781167)Rich-Mar Corp.1978-09-15
SIGNAL AVERAGER MODEL 4202 (K781290)Princeton Applied Research Corp.1978-09-15
OPTIPLANIMAT (K781531)Siemens Corp.1978-09-14
MODEL 5000, LIQUID CHROMATOGRAPHY (K781379)Varian Assoc., Inc.1978-09-14
EMI SIMULATOR REMOTE CONTROL CONSOLE (K781519)Emi Medical, Inc.1978-09-14
CREATININE REAGENT SET (K781396)Nobel Scientific Industries, Inc.1978-09-14
RIANEN ASSAY SYSTEM, 125I KIT (K781495)New England Nuclear1978-09-14
MODEL 845T IMAGING/ERGOMETER TABLE (K781500)Quinton, Inc.1978-09-14
FORCEPS, ELECTROSURGICAL (K781109)Kli1978-09-14
HEMOGLOBINOMETER MODEL 720 B (K781361)Innovative Medical Systems, Inc.1978-09-14
OXYGENATOR, BUBBLE TYPE (K780078)Bentley Laboratories, Inc.1978-09-14
COMPUTER INTERFACE IL 814 (K781173)Instrumentation Laboratory CO1978-09-14
VAC-U-PAC KIDNEY CASSETTE (K781536)E-Z-Em, Inc.1978-09-14
AUTO-FIELD II OPHTHALMIC FIELD SCANNER (K781462)Cavitron Corp.1978-09-14
EBS 775 TONOMETER (K781386)Equilibrated Bio Systems, Inc.1978-09-14
QUANTICEL-HRP (K781247)Bhp Diagnostix, Inc.1978-09-14
CLINAC 12/10 (K781174)Varian Assoc., Inc.1978-09-14
PRESSURE INFUSION DEVICE (K781037)Hinck Medical, Inc.1978-09-14
ORTHO LOW IONIC SOLUTION (K781435)Ortho Diagnostics, Inc.1978-09-14
PREAMPLIFIER MODEL 113 (K781289)Princeton Applied Research Corp.1978-09-14
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Every clearance here is in the API, with alerts when new ones post.