Atlas FDA

1983

3,564 FDA 510(k) clearances · Clearance year

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RecordFirmDate
BIOSENSOR ASC SYSTEM (K831676)Biosensor Corp.1983-12-01
PATIENT MONITOR CM 135 (K831164)Honeywell, Inc.1983-12-01
SOLUTION ADMINISTRATION LINE W/SPIKE (K833178)Intramed, Inc.1983-11-30
PERCUTANEOUS ENDOSCOPIC GASTROSCOPY (K833492)American Endoscopy, Inc.1983-11-29
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE (K833595)Travenol Laboratories, S.A.1983-11-29
KNEE WALKER (K833870)Maddak, Inc.1983-11-29
OHIO GMS ABSORBER (K833452)Airco/Ohio Medical Products1983-11-29
BUNN MICRO OXYGEN CONCENTRATOR (K833495)Greene & Kellogg, Inc.1983-11-29
FRASER HARLAKE DENTAL ANTI-POLUTION SYS (K833692)Fraser Harlake, Inc.1983-11-29
CHILD'S WALKER (K833869)Kaye Products, Inc.1983-11-29
BIFOCAL 3.0MHZ (K833224)Adr Ultrasound1983-11-29
POINTER F-3 (K833037)Petra Intl. Co.1983-11-29
HOBBS MEDICAL RETRIEVAL BASKET (K833124)Hobbs Medical, Inc.1983-11-29
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS (K830197)Diamond Shamrock Corp.1983-11-29
RENALLOY HEMASITE VASCULAR ACCESS SHUNT (K833622)Renal Systems, Inc.1983-11-29
MASSATOR-PEDIO (K833840)Trileen, Inc.1983-11-29
SYSTENET (K832544)American Intl. Medical Supply Co.1983-11-29
TELEPHONIC RECEIVER R-10 EEG (K833880)Pharmaquest Corp.1983-11-29
COAXIAL BALLOON URETHRAL DILATOR (K833690)American Edwards Laboratories1983-11-29
TRICON M TOTAL KNEE SYSTEM (K833200)Richards Medical Co., Inc.1983-11-29
WINDSOR MEDICAL VARIOUS MODELS (K832606)Windsor Medical, Inc.1983-11-29
DRY GEL (K833441)Concept, Inc.1983-11-29
DISPOSABLE SYRINGES & NEEDLES (K833493)Aldrich Chemical Co., Inc.1983-11-29
TELEPHONE TRANSMITTER T-10 EEG (K833236)Pharmaquest Corp.1983-11-29
3M SCOTCHPLATE II DISPERSIVE ELECTRODE (K833364)3M Company1983-11-29
MAX 02 OXYGEN CONCENTRATOR (K833500)Mountain Medical Equipment, Inc.1983-11-29
REVIVE (K833244)Aladdin Industries, Inc.1983-11-29
OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S (K833648)Edward Weck, Inc.1983-11-29
MBS HARD TISSUE REPLACEMENT SYSTEM (K832509)Medical Biological Sciences, Inc.1983-11-29
CLIP APPLYING FORCEPS (K833651)Advanced Biosearch Assn.1983-11-29
IV EXTENSION SET (K833659)Dna Medical, Inc.1983-11-29
HAND CONTROLLED PENCIL OR SWITCH HAND (K833449)Cameron-Miller, Inc.1983-11-29
RX SEG ECONOPLUS (K833286)Genesis Industries, Inc.1983-11-28
FEEDING TUBE (K833591)Medovations, Inc.1983-11-28
SURGICAL INSTRUMENT (K833541)Hirata Sangyo Co. USA, Inc.1983-11-28
PRIMARY PIGGYBACK INFUSION SET W/PERM (K833682)Cosmetic Sciences, Inc.1983-11-28
ENTRI FLEX FEEDING TUBE (K833621)Biosearch Medical Products, Inc.1983-11-28
LINEAR VIBRATION A MCSHIRLEY PRODUCT (K833370)Mcshirley Products, Inc.1983-11-28
COMPUTERSCOPE CPS-ABR (K833413)Rc Electronics, Inc.1983-11-28
SYRINGE,PISTON NEEDLE, HOLLOW LUMEN (K833460)Aldrich Chemical Co., Inc.1983-11-28
BETATRON I AMBULATORY INSULIN PUMP (K833306)Cardiac Pacemakers, Inc.1983-11-28
TOURNIQUET CUFF PRESSURE MONITOR #TCPM (K832272)Electromedics, Inc.1983-11-28
AUTO-TENS MODEL VI DUAL CHANNEL BATT (K833354)Physio Tronics Corp.1983-11-28
RX 41 PENTRON 41 (K833284)Genesis Industries, Inc.1983-11-28
TRI-MED 511 INFANT RESPIRATION MONITOR (K833397)Tri-Med, Inc.1983-11-28
SURGICAL IOP MONITOR (K832996)Miami Eye Technology, Inc.1983-11-28
RELEASE OF ETHYLENE OXIDE-STERILIZ. DEV (K832558)Deseret Medical, Inc.1983-11-28
D-LYTE (K833653)Dialysis Products, Inc.1983-11-28
THERMAMED BATH (K833631)Bernlit Enterprises, Inc.1983-11-28
CHEMONUCLEOLYSIS TABLE (K833509)Stryker Corp.1983-11-28
AUTOMATIC PERITONEAL DIALYSIS CYCLER (K833065)Travenol Laboratories, S.A.1983-11-28
TUBING FOR CARDIOPULMONARY BYPASS (K833112)Cardio Med Supplies, Inc.1983-11-28
ZENITH (K833145)Jeneric Ind.1983-11-28
NEUROFLAX, EPK (K831990)Franks Electronics1983-11-28
INTRABIONIC CO. - MICRO SYRINGE (K832350)Intrabionic Co.1983-11-28
HALL ARTHROTOME (K832816)American Sterilizer Co.1983-11-28
PROTECTIVE SLEEVE (K832380)Vertex Medical Corp.1983-11-28
REGULAR DEODORANT MAXITHINS PADS (K832972)Tampax, Inc.1983-11-28
COAXIAL ELECTRODE #300A (K832566)K-Med, Inc.1983-11-28
PRI A PUS (K832756)Trans Texas Medical Devices Corp.1983-11-28
HYDROFLOW SUCTION IRRIGATION SYSTEM (K833189)Portex, Inc.1983-11-28
RX D PENTRON (K833281)Genesis Industries, Inc.1983-11-28
PROGRAMED (K832349)Intrabionic Co.1983-11-28
PDM SILOXANE PROSTHETIC OBTURATOR (K832149)Delaware Prosthetics, Inc.1983-11-28
DEODORANT MAXITHINS PANTY SHIELD (K832971)Tampax, Inc.1983-11-28
MICRO-SAMPLE OSMOMETER 3M0 (K832783)Advanced Instruments, Inc.1983-11-28
ENDOSCOPIC RETROGRADE (K833417)Microvasive1983-11-28
NEEDLE CATHETER JEJUNOSTOMY KIT (K833513)Biosearch Medical Products, Inc.1983-11-28
IPOS G.L.P. SYSTEM (K833868)Ipos Luneburg1983-11-28
MULTIPLE (K831204)Derma-Lock Medical Corp.1983-11-28
RX ORY PENTRON C & B (K833283)Genesis Industries, Inc.1983-11-28
FPC FECAL PARASITE CONCENTRATOR (K833469)Evergreen Scientific, Inc.1983-11-28
SINUSVU 2500 (K833222)Radionics Medical, Inc.1983-11-28
JH PEPTONE AGAR (K833291)Acumedia Manufacturers, Inc.1983-11-28
PRESERV PVA FIXATIVE -MALIN PACK (K833660)Preventive Diagnostics Corp.1983-11-28
ELECTROCARDIOCORDER RECORDER 453 (K833661)Del Mar Avionics1983-11-28
NATURELLE-LITE (K833279)Genesis Industries, Inc.1983-11-28
TAMPAX SUPER DEODORANT MAXITHINS (K832973)Tampax, Inc.1983-11-28
VOLUREX II (K833337)Dhd Medical Products Div. Diemolding Corp.1983-11-28
SURGICAL INSTRUMENT (K833542)Hirata Sangyo Co. USA, Inc.1983-11-28
AQUEOUS BLOOD GAS CONTROL (K833146)Bionostics, Inc.1983-11-28
HOT/ICE DISPOSABLE BLANKET (K833564)Thermo Temp, Inc.1983-11-28
ACTIVE LIFE (K833625)Convatec, A Division of E.R. Squibb & Sons1983-11-28
PDM SILOXANE PROSTHETIC CHIN IMPLANT (K832148)Delaware Prosthetics, Inc.1983-11-28
VECTOR SEIGE 2023645 AC POWERED STIMU- (K833305)Metronex Engineering1983-11-28
PDI SURGICAL SCRUB/BRUSH T150-70 (K833549)Nice-Pak Products, Inc.1983-11-28
RESPIRATORY FLOW MODULE (K833265)Thoratec Laboratories Corp.1983-11-28
CORDIA HS (K832875)Cordis Corp.1983-11-28
MODIFICATION IN MEMBRANE HOUSING CONFI (K832925)Ries Biologicals1983-11-28
EGERTON TURNING & TILTING NET SUSPEN BED (K832845)Kinetic Concepts, Inc.1983-11-28
RX NYSP PENTRON 60 (K833282)Genesis Industries, Inc.1983-11-28
LUMEN-4 URODYNAMIC CATHETER (K833628)Surgitek1983-11-28
GENTLE FLOW BREAST PUMP (K833835)Eklund & Co.1983-11-28
RESPIRONICS PR VALVE (K833327)Respironics, Inc.1983-11-28
SHUTT UNIVERSAL STRESS POST (K833624)Concept, Inc.1983-11-28
SONICOMP (K833488)Sonicaid, Inc.1983-11-28
QUIDEL HCG ENZYME IMMUNOASSAY KIT (K833156)Quidel Corp.1983-11-25
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU (K833153)Nova Biomedical Corp.1983-11-25
AMYLASE (K832889)Pointe Scientific, Inc.,1983-11-25
QUICK STAIN WRIGHT'S GIEMSA W/BUFF (K833677)J.S. Medical Assoc.1983-11-25
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Every clearance here is in the API, with alerts when new ones post.