Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
CARE TELSTAT MODELS: MP 5010 AND MP 5020 (K874844)Care Systems, Inc.1988-02-09
KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0 (K874857)Eastman Kodak Company1988-02-08
STARKEY MODEL P1 MODULE (K873031)Starkey Laboratories, Inc.1988-02-08
5 MHZ DOPPLER OUTRIGGER (K872817)Philips Ultrasound, Inc.1988-02-08
LUNAR CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL (K874821)Deringer-Ney, Inc.1988-02-08
CABOT MEDICAL ENDOMETRIAL SUCTION CURETTE (K875084)Cabot Medical Corp.1988-02-08
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT (K874944)Dentsply Intl.1988-02-08
GASTROPLASTY CALIBRATING TUBE & GASTROSTENOMETER (K874690)Mentor Corp.1988-02-08
KODAK SURECELL(TM) HCG-URINE KIT (K874388)Eastman Kodak Company1988-02-08
DIAMOND MEDICAL, INC. MODEL DM 800 (K874709)Diamond Medical, Inc.1988-02-08
DIAMOND MEDICAL, INC. MODEL DM 600 (K874710)Diamond Medical, Inc.1988-02-08
TROUSERS, PNEUMATIC, ANTI-SHOCK THREE BLADDERS (K874774)Vinyl Technology, Inc.1988-02-08
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) (K875263)Technicon Instruments Corp.1988-02-08
MODEL ISO-2001 UNIV. PATIENT ISOLATION CIRCUIT (K875369)Diamond Medical, Inc.1988-02-05
NEW MODEL MB-550 BLOOD PRESSURE MONITOR (K875093)Sharp Electronics Corp.1988-02-05
LEVTECH COMPOSITE TRACTION TONGS (K873693)Levtech, Inc.1988-02-05
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2610 (K874338)A&D Engineering, Inc.1988-02-05
RADIALLY-SUPPORTED VASCULAR PROSTHESES (K870884)Intervascular, Inc.1988-02-05
ADVANCED SURGICAL PRODUCTS SCLERAL PLUG FORCEPS (K880274)Advanced Surgical Products, Inc.1988-02-05
NAMIC ANGIOGRAPHIC SYRINGE (K873955)North American Instrument Corp.1988-02-05
MEDRAD MRI INJECTION SYSTEM (K873173)Medrad, Inc.1988-02-05
TARGET THERAPEUTICS STERILE PRODUCTS (K874815)Target Therapeutics1988-02-05
IRAS EDS INTERFEROMETRIC STIMULATOR (K873990)Randwal Instrument Co., Inc.1988-02-05
POLYSTAN TWO STAGE CATHETERS (K874853)Polystan C/O Vitalcor, Inc.1988-02-05
CARDIOVASCULAR SURGICAL INSTRUMENTS (K874960)Solway, Inc.1988-02-05
POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS (K874852)Polystan C/O Vitalcor, Inc.1988-02-05
BELLA - VAC IRRIGATOR (K874493)Bel-Can Industries1988-02-05
LAWRENCE L3000 CARDIAC OUTPUT MONITOR (K874885)Lawrence Medical Systems, Inc.1988-02-05
MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM (K874171)Hewlett-Packard Co.1988-02-05
ORTHODERM THERAPY BED (K874801)Health Products, Inc.1988-02-05
ANOMALOSCOPE PLATE TEST - 5 [APT-5] (K875026)Lkc Technologies, Inc.1988-02-05
BIOTIS (TM) HAEMOPHILUS DUCREYI (K874176)Otisville Biopharm, Inc.1988-02-05
MODEL 5202 MICROMANIPULATOR (K874811)Coherent Medical Group1988-02-05
SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES (K874681)Klockner Contract Packaging, Inc.1988-02-05
THROMBOPLASTIN.C (K874592)Baxter Healthcare Corp1988-02-04
AEROBICA - LUNG EXERCISER (K873540)MBA Healthcare Products, Inc.1988-02-04
MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME (K874298)Engineered Orthopedic Technologies, Inc.1988-02-04
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (K880157)Syva Co.1988-02-04
EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES (K880205)Baxter Healthcare Corp1988-02-04
V-TREND RPRL CARD TEST (K875180)Texas Immunology, Inc.1988-02-04
10CC SYRINGE CONTROL RING SET (K874747)Procedure Products, Inc.1988-02-04
ORTHOMET ORTHOPEDIC STAPLES (K874914)Orthomet, Inc.1988-02-04
HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 (K874429)Hf Scientific, Inc.1988-02-04
BREEZY WHEELCHAIR (K880280)Motion Designs, Inc.1988-02-04
TED MODEL 760 (K871828)Teledyne, Inc.1988-02-04
EXTRAVAKIT (K874807)Cancer Technologies, Inc.1988-02-04
A-V RECORDER (K873041)Life Sciences Manufacturing, Inc.1988-02-04
COHERENT XA-30/SP CO2 SURGICAL LASER (K874648)Coherent Medical Group1988-02-04
ZENITH TRAVELER CHIROPRACTIC TABLE (K880222)Williams Manufacturing Co.1988-02-03
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS (K874915)Orthomet, Inc.1988-02-03
NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP (K871848)Panamedix, Inc.1988-02-03
BIOTROL CALIBRANT LEVEL 2 (K875304)Biotrol, USA, Inc.1988-02-03
ELECTRODE TIP CLEANER (K874775)C.R. Bard, Inc.1988-02-03
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH (K875252)E.I. Dupont DE Nemours & Co., Inc.1988-02-03
RESUBMITTED EXCALIBUR (K880271)Quinton, Inc.1988-02-03
SUTTER PHALANGEAL CAP (K875249)Sutter Biomedical, Inc.1988-02-03
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM (K870708)Kyoto Daiichi Kagaku Co., Ltd.1988-02-02
OHMEDA 4700 OXICAP MONITOR (K873199)Ohmeda Medical1988-02-02
BIOTROL CALIBRANT LEVEL 3 (K875318)Biotrol, USA, Inc.1988-02-02
STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III (K874757)Baxter Healthcare Corp1988-02-02
BETA-HCG ASSAY (K873986)Schiff & Co.1988-02-02
PIE MEDICAL SCANNER 1000 (K870058)Pie Data Medical BV1988-02-02
V-TREND BETA-HCG DRY-SPOT TEST (K875262)Texas Immunology, Inc.1988-02-02
SARNS VISIFLOW AORTIC ARCH CANNULA (K874896)3M Health Care, Sarns1988-02-02
ULTRASOUND LINEAR/SECTOR SCANNER 1100 (K870653)Pie Data Medical BV1988-02-02
MODEL 20-C, RL-20A/U, OB-10A/U (K872709)Directed Energy, Inc.1988-02-02
GAMOW HYPERBARIC BAG (K874752)Hyperbaric Aerobics, Ltd.1988-02-02
FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS (K874962)Solway, Inc.1988-02-02
SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE (K873892)Laserguide1988-02-02
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23 (K875210)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
BIOTROL CALIBRANT LEVEL 1 (K875288)Biotrol, USA, Inc.1988-02-02
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (K874841)Bentley Laboratories, Inc.1988-02-02
MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD (K873962)Medtronic Vascular1988-02-02
WAKO(TM) UIBC (K875176)Wako Chemicals USA, Inc.1988-02-02
LACTATE DEHYDROGENASE CAT. # 320-68, 320-69 (K875206)Diagnostic Chemicals, Ltd. (Usa)1988-02-02
QUANTIMETRIX TOTAL CREATINE KINASE CONTROL (K874302)Quantimetrix Medical Industries1988-02-02
STERILIZATION OF DEVICES BY RADIATION (K874659)Inhalation Plastics1988-02-02
PULSEMATE BX-5 (K874692)Colin Medical Instruments Corp.1988-02-02
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605)Mallinckrodt Critical Care1988-02-02
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN (K870841)Directed Energy, Inc.1988-02-02
MODIFIED CALCITONIN RIA KIT DSL #1200 (K874087)Diagnostic Systems Laboratories, Inc.1988-02-02
CATR(TM)-H CARDIOTOMY HOLDER (K874867)Bentley Laboratories, Inc.1988-02-02
OVEIA (TM) DUAL ANALYTE (K872843)Boots-Celltech Diagnostics, Inc.1988-02-02
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE (K875104)Laserguide1988-02-02
ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T (K874205)Pacesetter Systems1988-02-02
PTI HEART-CHILL POUCH/PAD SLING (STERILE) (K873924)Buckman Co., Inc.1988-02-02
SCHURMAN/CARTER II HIP PROSTHESIS, POROUS COATED (K874939)Kirschner Medical Corp.1988-02-02
ELECTROSTIM I.F. (K873566)Promatek Industries, Ltd.1988-02-01
ACID PHOSPHATASE (KINETIC) CAT. # 320-06 (K875209)Diagnostic Chemicals, Ltd. (Usa)1988-02-01
BIOTROL URIC ACID ENZYMATIQUE UV H.P. (K875320)Biotrol, USA, Inc.1988-02-01
KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 (K870815)Kontron Instruments, Inc.1988-02-01
EDEC 60 R/F (K875341)Electromed Intl., Ltd.1988-02-01
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900 (K874695)Healthdyne, Inc.1988-01-29
KEELER ACU 22XT OPHTHALMIC CRYO UNIT (K874555)Keeler Instruments, Inc.1988-01-29
UNICATH LAB (K875184)Xre Corp.1988-01-29
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD (K874183)Daig Corp.1988-01-29
EDEC 90C (K875342)Electromed Intl., Ltd.1988-01-29
OMED DISPOSABLE SCALPEL (K880028)Oxboro Medical Intl., Inc.1988-01-29
PATIENTWATCH (TM) (K874571)Advanced Medical Technology, Inc.1988-01-29
NAMIC HAWKINS UNIVERSAL DRAINAGE SET (K873954)North American Instrument Corp.1988-01-29
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Every clearance here is in the API, with alerts when new ones post.