Atlas FDA

1986

4,347 FDA 510(k) clearances · Clearance year

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RecordFirmDate
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 (K864715)Em Diagnostic Systems, Inc.1986-12-31
CHLORIDE REAGENT (K864713)Sigma Diagnostics, Inc.1986-12-31
ALANINE AMINO TRANSFERASE ALT/SGPT (K864906)Tech-Co, Inc.1986-12-31
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS (K864776)Bartels Immunodiagnostic Supplies, Inc.1986-12-31
QKO (TM) AMYLASE B-HA (K864303)Wako Chemicals USA, Inc.1986-12-31
DERMATEC TRANSPARENT FILM DRESSING (K863580)Dermatec, Inc.1986-12-31
MAGNESIOMETER (K863069)J. D. Assoc.1986-12-31
AP1 COLORIMETER (K864634)Awareness Technology, Inc.1986-12-31
SYNCHRON CX3 (K864236)Beckman Instruments, Inc.1986-12-31
BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT (K864939)Beckman Instruments, Inc.1986-12-31
ELLISON ARTHROSCOPY CHEATER (K864892)Buckman Co., Inc.1986-12-30
PAMITEX,LONG LOVE,DESIRE,SKIN LESS,GINZA,LOVE TIME (K864570)Dongkuk Techco Rubber Industries1986-12-30
MEDSURG VASCULAR ACCESS PORT INFUSION TRAY (K864495)Medsurg Industries, Inc.1986-12-30
DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY (K864292)Eye-Ko, Inc.1986-12-29
FMS MODEL 110 (K863736)Flir Medical Systems1986-12-29
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 3ML/CC (K864777)Mac Lee Medical Products1986-12-29
COLLINS POSITIONING DEVICE (K864880)Orthopedic Systems, Inc.1986-12-29
FLUOROVISION CONTRAST ENHANCER (K864584)Digivision, Inc.1986-12-29
REUSABLE SURGICAL KERATOSCOPE (K864639)Jedmed Instrument Co.1986-12-29
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC (K864781)Mac Lee Medical Products1986-12-29
KC/EMG DIAGNOSTIC ELECTROMYOGRAPH (K864630)Chattanooga Group, Inc.1986-12-29
HYDROXYLAPATITE BONE GRAFT MATERIAL (K863237)Richards Medical Co., Inc.1986-12-29
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC (K864779)Mac Lee Medical Products1986-12-29
ADA-1000 (ADVANCED DIGITAL ARRAY) (K863780)Diasonics, Inc.1986-12-29
MUSCLE MASTER (MEDIUM VOLTAGE STIMULATOR) (K864284)Modern Systems Technology, Inc.1986-12-29
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 30ML/CC (K864778)Mac Lee Medical Products1986-12-29
ARTHROSCOPIC ANKLE HOLDER (K864881)Orthopedic Systems, Inc.1986-12-29
U66 EMS (K864558)Suntec Health & Fitness Group, Inc.1986-12-29
VARIOUS SYRINGES W/NEEDLES, W/OUT NEEDLES, NEEDLES (K864747)Jms Co., Ltd.1986-12-29
MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS (K864653)Rich-Mar Corp.1986-12-29
TRICOTEX WOUND CONTACT LAYER DRESSING (K864264)Smith & Nephew, Inc.1986-12-29
NEOPROBE PORTABLE RADIOISOTOPE DETECTOR (K864263)Neoprobe Corp.1986-12-29
HERCON ANTISEPTIC TRANSPARENT DRESSING (K864076)Hercon Laboratories Corp.1986-12-29
CULTURIA MACCONKEY-MUG/CLED SYSTEMS (K864764)Clinical Convenience Products, Inc.1986-12-29
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM (K864676)American V. Mueller1986-12-29
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP (K864138)Medtronic Minimed1986-12-29
MLC ENDOTHELIAL CELL COUNTER (K863970)Mlc Technologies1986-12-29
MYOPAC (TM), MODEL 9600 (K864625)Medical Devices, Inc.1986-12-29
EXACTECH TOTAL HIP INSTRUMENTS (K864788)Exactech, Inc.1986-12-29
CARETEX SHOE COVERS (K864550)James River Corp.1986-12-24
HEALTH PRODUCTS, INC. ORTHODERM THERAPY CHAIR (K864918)Health Products, Inc.1986-12-24
THE KEYMED HI-LIGHT 250 LIGHT SOURCE (K864801)Keymed, Inc.1986-12-24
FASCICULATED BOAT ROD (K863239)The Deca Co.1986-12-24
FASCICULATED S ROD (K863271)The Deca Co.1986-12-24
HIGH FREQUENCY NEEDLE-TYPE EPILATOR (K864291)Multi-Channel Epilator1986-12-24
CLOWARD DISPOSABLE ARMRESTS AND FACE REST (K864804)Surgical Equipment International, Inc.1986-12-24
MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (K864184)Mcghan Medical Corp.1986-12-24
RADIOGRAPHIC - LEG SECTION (K864846)American Sterilizer Co.1986-12-24
FASCICULATED I ROD (K863215)The Deca Co.1986-12-24
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (K864185)Mcghan Medical Corp.1986-12-24
2000LT WHEELCHAIR (K864901)Invacare Corp.1986-12-24
INFECTIOUS TISSUE KIT (K864824)American Scientific Products1986-12-24
AKRO-SIL PLUS (K864736)Akron Catheter, Inc.1986-12-24
CLOWARD SURGICAL SADDLE (K864805)Surgical Equipment International, Inc.1986-12-24
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC (K864782)Mac Lee Medical Products1986-12-23
BIOPSY ADAPTER #H4221BG (K864551)General Electric Co.1986-12-23
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC (K864780)Mac Lee Medical Products1986-12-23
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC (K864783)Mac Lee Medical Products1986-12-23
IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (K864409)Sclavo, Inc.1986-12-22
NELLCOR MVP, MODEL N-1000 (K862812)Nellcor, Inc.1986-12-22
AXION IV GOLDLINE SERIES (K862602)Ventura Medical Electronics1986-12-22
BINAX STREP A (K863908)Binax, Inc.1986-12-22
KENZ-ECG 102 (K863965)Compumed, Inc.1986-12-22
HEALTHPHONE(TM) (K862668)Carelink1986-12-22
NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (K863494)Advantage Medical Systems, Inc.1986-12-22
M700 STRESS MONITOR (K863466)Kone Instruments, Inc.1986-12-22
RNET SYSTEM, IV RECEIVING TERMINAL, TRANSMITTER (K863716)Futurecare Systems, Inc.1986-12-22
OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM (K862837)Osteonics Corp.1986-12-22
TISSUE GRAM STAIN (K864531)Sigma Diagnostics, Inc.1986-12-22
NBP 488, TPR 488 (K861856)Siemens Medical Solutions USA, Inc.1986-12-22
CHOICE (K864482)Select Sources, Inc.1986-12-22
BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR (K864754)Pudenz-Schulte Medical Research Corp.1986-12-22
BREMER HALO SYSTEM (K864746)Bremer Orthopedics1986-12-22
EM TENS WINDOW ELECTRODES (K864032)Electromed Intl., Ltd.1986-12-22
TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE (K863841)Hybritech, Inc.1986-12-22
FLUORESCENCE CONCENTRATION ANALYZER (FCA) (K864699)Pandex Laboratories, Inc.1986-12-22
SPECIFIC IGE FAST(TM) TEST II (K863967)3M Company1986-12-22
OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM (K863668)Osteonics Corp.1986-12-19
STERILITE STERILIZATION KIT (K864596)Kimberly-Clark Corp.1986-12-18
METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. (K863492)Surgitek1986-12-18
DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT (K864133)Diagnostic Systems Laboratories, Inc.1986-12-18
SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC) (K864414)Seal Syringe Corp.1986-12-18
EXTENSION SETS (K864692)Salt Creek Medical Technologies1986-12-18
TOWELS (K864528)Elof Hansson, Inc.1986-12-18
BUTTERFLY NON-CORING NEEDLE SET (K863606)Cormed, Inc., Sub. C.R.Bard, Inc.1986-12-18
MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. (K864631)Downs Surgical , Ltd.1986-12-18
CK 6000 SERIES, TOWELS (K864697)Currie Medical Specialties, Inc.1986-12-18
LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 (K862848)Lkb Instruments, Inc.1986-12-18
MANAN CONTRAST MEDIA ADMINISTRATION SET (K864405)Manan Manufacturing Co., Inc.1986-12-18
VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER (K864350)ETHICON, Inc.1986-12-18
MIC - CONCEPT(TM) RX-2 (K863847)Microtech Medical Systems, Inc.1986-12-18
STORZ SOLID & ANGLED SOLID CONTACT PROBES (K864398)Storz Instrument Co.1986-12-18
OPHTHASONIC A-SCAN (K860757)Teknar, Inc.1986-12-18
VITALLIUM HEX-DRIVE BONE SCREW SYSTEM (K864633)Howmedica Corp.1986-12-18
ANGEL LATEX SURGICAL GLOVES (K864521)Kim Intl. Trading Co.1986-12-18
V100 VISUALLY EVOKED POTENTIAL MONITOR (K860910)New Potentials, Inc.1986-12-18
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM (K864403)Howmedica Corp.1986-12-18
POIRIER MANUAL WHEELCHAIR (K864790)Roseburg SA1986-12-17
MODEL 668, TRACTION SPLINT, ADULT (K864765)Ferno-Washington, Inc.1986-12-17
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. (K863122)Surgicot, Inc.1986-12-17
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Track 1986 automatically

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