Atlas FDA

1980

2,857 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SILANIT (K802679)Vivadent (Usa), Inc.1980-12-17
POROUS COATED ANATOMICAL-TOTAL KNEE (K802922)Howmedica Corp.1980-12-17
SONIC EAR (K802382)Acousticon Electronics1980-12-16
HP MODEL 77020A ULTRASOUND SYSTEM (K801954)Hewlett-Packard Co.1980-12-16
FIBER OPTIC ADAPTER #60-0892 (K802774)Aspen Laboratories, Inc.1980-12-16
ELECTRONIC DIGITAL THERMOMETER (K802897)Philip J. Teders1980-12-16
MODEL EEG 4221 (K802887)Nihon Kohden America, Inc.1980-12-16
WILLIAM HARVEY OXYGENATING GAS FILTER (K802906)C.R. Bard, Inc.1980-12-16
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-5S (K802720)Bentley Laboratories, Inc.1980-12-16
BLOOD PRESSURE UNIT MODEL 410 (K802412)Js & A Group1980-12-16
FIBER OPTIC ADAPTER #60-0894 (K802772)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-895 (K802771)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER CAT#60-0898 (K802766)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT GUIDE #60-0767 (K802773)Aspen Laboratories, Inc.1980-12-16
SYNTHES SPINAL IMPLANT SYSTEM (K802462)Synthes (Usa)1980-12-16
FIBER OPTIC LIGHT GUIDE CAT#60-0768 (K802767)Aspen Laboratories, Inc.1980-12-16
OXYGEN SATURATION METER MODEL NO. SM-1 (K802847)Bentley Laboratories, Inc.1980-12-16
SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S (K802719)Bentley Laboratories, Inc.1980-12-16
MS 16 SYRINGE DRIVER (K802400)Princeton Medical Instruments, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0897 (K802768)Aspen Laboratories, Inc.1980-12-16
BLOOD PRESSURE UNIT MODEL 310 (K802411)Js & A Group1980-12-16
ARGYLE CLOSED URINARY DRAINAGE SET (K802667)Sherwood Medical Co.1980-12-16
TECNOL TELEMETRY UNIT POUCH (K802849)Tecnol New Jersey Wound Care, Inc.1980-12-16
UNIFOCAL VP, MODELS 7501 AND 7502 (K800746)American Pacemaker Corp.1980-12-16
SURGEONS CHOICE STAPLE, REMOVE/IMPLANT (K802783)Hospital Products Intl.1980-12-16
ORTRON 90* HIP PROSTHESIS (K802627)Cintor Orthopaedic Div.1980-12-16
PUIG MASSANA-SHILEY ANNULOPLASTY RING (K801879)Shiley, Inc.1980-12-16
ARGYLE HEMATURIA BALLOON CATHETER (K802875)Sherwood Medical Co.1980-12-16
CYE BIPHASIC BLOOD CULTURE MEDIUM (K802571)Remel Co.1980-12-16
DPA 207 PERSONAL (K802513)Hill, Farrer & Borrill1980-12-16
POLYCARBONATE TEMPORARY CEMENT (K802662)Buffalo Dental Mfg. Co., Inc.1980-12-16
LARES HANDPIECE OIL (K801535)Lares Manufacturing Co., Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0896 (K802775)Aspen Laboratories, Inc.1980-12-16
CMR 300, ROWATER TREATMENT UNIT (K802474)U-Marc, Inc.1980-12-15
VIDA 55 PULSE-ECHO ULTRASONIC DEVICE (K802279)Vida, Inc.1980-12-15
UPPER EXTREMITY TRACTION DEVICE (K803021)Orthopedic Systems, Inc.1980-12-12
SERIES 1800 EXERCISE TREADMILL (K802836)Marquette Electronics, Inc.1980-12-11
FIBER OPTIC HEADLIGHT #60-0766766 (K802770)Aspen Laboratories, Inc.1980-12-11
TIBIAL FRACTURE BRACE (K802871)Orthomedics1980-12-11
HEMATIC BLOOD MIXER (K802608)Helmer Labs, Inc.1980-12-11
COMBINATION PADS STERILE SINGLES (K802861)Abco Dealers, Inc.1980-12-11
GAMMEX SURGICAL GLOVES (K802641)Ansell, Inc.1980-12-11
STERNUM SAW BLADE (K802838)Amsco Co.1980-12-11
CULTURE MEDIA FOR IN VITRO DIAG. USE (K802892)Radiation Technology, Inc.1980-12-11
PARAGON ELECTROPHORESIS LACTATE REAG.KIT (K802628)Beckman Instruments, Inc.1980-12-11
FIBER OPTIC HEADLIGHT #60-0765 (K802769)Aspen Laboratories, Inc.1980-12-11
COMBUNED CALCIUM AND PHOSPHORUS STD. (K802824)Mallinckrodt Critical Care1980-12-11
125I-TESTOSTERONE TEST SET (K802728)Wien Laboratories, Inc.1980-12-11
AUFRANC-TURNER ATS TOTAL HIP SYSTEM (K802872)Howmedica Corp.1980-12-11
BUN/GLUCOSE STANDARDS (K802633)Gilford Diagnostics1980-12-11
BECKMAN ICS DRUG CONTROL SERA (K802854)Beckman Instruments, Inc.1980-12-11
COMBINED GLUCOSE AND BUN STANDARDS (K802825)Mallinckrodt Critical Care1980-12-11
COMPU-CHEM II CHEMISTRY ANALYZER (K802835)Diagnostic Aids, Inc.1980-12-11
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) (K802753)Oxoid U.S.A., Inc.1980-12-11
BOUIE ELECTROSURGICAL TIP CLEANER (K802827)Sybron Corp.1980-12-11
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT (K802821)Beckman Instruments, Inc.1980-12-11
SIAM 80-INSTANTANEOUS SONOGRAPH W/STOR. (K802704)Cgr Medical Corp.1980-12-11
ALBUMIN/TOTAL PROTEIN STANDARDS (K802632)Gilford Diagnostics1980-12-11
VISTA 54 LIQUID CHROMATOGRAPHY ANAL. SYS (K802725)Varian Assoc., Inc.1980-12-11
CREATININE STANDARDS (K802631)Gilford Diagnostics1980-12-11
OPRATEX ABDOMINAL PAD (K802798)Secol Co.1980-12-11
PLATELET COUNTING KIT (K802636)Streck Laboratories, Inc.1980-12-11
SERA-PAK TOTAL PROTEIN REAGENT (K802742)Miles Laboratories, Inc.1980-12-11
GAUZE PADS STERILE SINGLES (K802862)Abco Dealers, Inc.1980-12-11
POST OP. SPONGES STERILE (K802860)Abco Dealers, Inc.1980-12-11
GAUZE SPONGES (K802863)Abco Dealers, Inc.1980-12-11
ARGYLE CONNECT TUBE-CON & NON (K802777)Sherwood Medical Co.1980-12-11
ELASTIC BANDAGE (K802785)Secol Co.1980-12-11
PARAGON LIPOPROTEIN ELECTRO. REAG. KIT (K802822)Beckman Instruments, Inc.1980-12-11
CHOLESTEROL STANDARDS (K802823)Mallinckrodt Critical Care1980-12-11
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. (K802634)Organon, Inc.1980-12-11
CARDIOPLEGIA COOLING SYST. CCAS-2 (K802848)Bentley Laboratories, Inc.1980-12-11
IMMULON REMOVAWELL STRIPS #011-010-6301 (K802857)Dynatech Corp.1980-12-11
GLYCOHEMOGLOBIN IN WHOLE BLOOD (K802721)Sigma Chemical Co.1980-12-11
BACKTRAC 90-90 TRACTION (K802869)Backtrac1980-12-11
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT (K802661)Damon Corp.1980-12-10
JACKSON HYDRO SYSTEM (K802780)S. Jackson, Inc.1980-12-10
OREIA-Q-TY, ENZYME IMMUNOASSAY (K802693)Organon, Inc.1980-12-10
POROUS, BREATHING TAPE W/RELEASE LINER (K802752)Bioadhesive Systems, Inc.1980-12-10
CENTRIFICHEM COMB. SERUM-BASED CALIB. (K802741)Union Carbide Corp.1980-12-10
HEXOKINASE, GLUCOSE (K802810)Beckman Instruments, Inc.1980-12-10
DIOSCAN (K802341)Sonometrics Systems, Inc.1980-12-10
AMES SERA-PAK URIC ACID REAGENT KIT (K802724)Miles Laboratories, Inc.1980-12-10
LOAD SENTINEL II, TRANS. ELEC. NERVE (K802779)Powers Medical Systmes1980-12-10
MILLAR MIKRO-TIP CATHETER PHONOTRANS (K802830)Millar Instruments, Inc.1980-12-10
TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) (K802820)Travenol Laboratories, S.A.1980-12-10
NEONATAL PHOTOTHERAPY UNIT (K802702)Ohio Medical Products1980-12-10
FLUFF UNDERPAD TYPE UP1001 (K802740)Bio D Corp.1980-12-10
ORTHOPEDIC PADDING (K802795)Secol Co.1980-12-10
ELASTIC OPEN WEAVE BANDAGE (K802784)Secol Co.1980-12-10
TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR (K802678)General Medical Industries, Inc.1980-12-10
ORTHOFIX AXIALEXTERNAL FIXATION SYS. (K802814)Cintor Orthopaedic Div.1980-12-10
DR. MICHAEL'S FOOT HELPER (K802837)Dr. Michael'S Foot-Care Products1980-12-10
TETRA NATAL-MAT WATER FLOTATION MAT. (K802833)Tetra Group U.S.A., Inc.1980-12-10
AMES SERA-PAK CHOLESTEROL REAGENT KIT (K802743)Miles Laboratories, Inc.1980-12-10
LANCER URIC ACID AUTO/STAT KIT (K802692)Sherwood Medical Co.1980-12-10
BEDDING PADS EGGCREATE PADS (K802781)Leemart Bedding Mfg. Co.1980-12-10
CELLONA (K802792)Secol Co.1980-12-10
FLUFF UNDERPAD TYPE UP1002 (K802730)Bio D Corp.1980-12-10
TUBULAR BANDAGE (K802789)Secol Co.1980-12-10
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Track 1980 automatically

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