Atlas FDA

1985

4,483 FDA 510(k) clearances · Clearance year

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RecordFirmDate
MEDIFLEX DISPOSABLE TUBING CLAMP (K854346)Mediflex Intl.1985-11-18
CAMPYLOBACTER BLOOD AGAR (K854456)R. Kent Richards, Inc.1985-11-18
MANNITOL SALT AGAR (K854452)R. Kent Richards, Inc.1985-11-18
BILE ESCULIN AZIDE AGAR (K854450)R. Kent Richards, Inc.1985-11-18
MUELLER HINTON MEDIUM (K854451)R. Kent Richards, Inc.1985-11-18
SUPER SLICK (K853882)Tang Products1985-11-18
COMBO 36 (K854257)Kg Engineering, Inc.1985-11-18
I.V. STAT MASTER (K852254)The Master Medical Corp.1985-11-18
CUSTOM PROCEDURAL TRAY PROCEDURAL KIT (K853759)Charles Atkins & Co.1985-11-17
BOOMERANG ABSORPTION COMENSATION FILTER (K853330)Entreprises Octostop, Inc.1985-11-15
G-T 1000 (K854020)G-T Products1985-11-15
A RANGE OF INSTRUMENTS & PLATES FOR MANDIBULAR COM (K853709)Downs Surgical , Ltd.1985-11-15
TECHNICARE 720 HPS CT SCANNER (K854340)Technicare Corp.1985-11-15
COLLAR LESS AML HIP (K853408)Depuy, Inc.1985-11-15
GOODLEY POLYAXIAL CERVICAL TRACTION UNIT (K854248)E-Z-Em, Inc.1985-11-15
TENSION-ISOMETER (K854254)Medmetric Corp.1985-11-15
SONGER TITANIUM SPINE-L-ROD (K854313)Ortho-Engineering Products Co.1985-11-15
ELLIPTI-PUNCH (K854159)Alcon Laboratories1985-11-15
JOHNS-ALLGOOD IRRIVAC DRIVE-IRRIGATOR/ASPIRATOR- (K854072)Dexide, Inc.1985-11-15
DUODERM HYDROACTIVE DRESSING W/BORDER STERILE (K853844)Convatec, A Division of E.R. Squibb & Sons1985-11-15
CUI CHIN SIZER (K854339)Cox-Uphuff Intl.1985-11-15
SHILEY 3L CARDIOTOMY RESERVOIR (K853503)Shiley, Inc.1985-11-14
SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL (K854099)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
MULTISTIM LAMINECTOMY ELECTRODE (K853643)Neuromed, Inc.1985-11-14
DIATEMP ELECTROSURGICAL PEN (K853968)Ndm Corp.1985-11-14
INDONTINENCE PAD (K853741)Beghin_Say Intl., Inc.1985-11-14
SCOTCHPRIME CERAMIC PRIMER (K853698)3M Company1985-11-14
CR5 CARDIAC MONITOR (K852887)Cardiac Recorders, Ltd.1985-11-14
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL (K854097)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SARNS RETROGRADE CARDIOPLEGIA DELIVERY SYSTEM (K853516)3M Health Care, Sarns1985-11-14
SCEPTOR GRAM POSITIVE MIC/ID PANEL (K854100)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
SCEPTOR GRAM POSITIVE MIC PANEL (K854101)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
UNISTIM UNT-1 (K852326)Neuromed, Inc.1985-11-14
DIGITAL SPHYGMOMANOMETER MODEL 7620 (K853158)Takeda Medical, Inc.1985-11-14
SCEPTOR PSEUDOMONAS PLUS MIC PANEL (K854098)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
PRESSURE SENSING SYRINGE 65000 (K853586)Dlp, Inc.1985-11-14
PCM DIGITAL AMBULA TORY ECG ANALYSIS SYSTEM (K852968)Personal Computers For Medicine, Inc.1985-11-14
DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA (K852284)Digirad Corp.1985-11-14
OXYCOIL (K854239)Chad Therapeutics, Inc.1985-11-14
FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR (K853352)Fukuda Denshi USA, Inc.1985-11-14
EBM-500 (K840574)Bosch Hearing Instruments, Inc.1985-11-14
SCEPTOR ENTERIC MIC PANEL (K854102)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
MVP - 6000 (K852909)Waters Instruments, Inc.1985-11-14
GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY (K852460)Healthteam1985-11-14
LOGOS8821 1-CHANNEL DIRECT-WRITING ELECTROCARDIOGR (K851662)Logos Medical Co., Ltd.1985-11-14
CMV TEST (K853137)Gull Laboratories, Inc.1985-11-14
CILAS MODEL YM101 (K852761)Inframed, Inc.1985-11-14
SCEPTOR ENTERIC MIC/ID PANEL (K854103)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-14
PLOTTER FOR AS-500 (K853922)Riko Medical & Scientific Instrument Corp.1985-11-14
MORGAN SUTURE-DRILL (K853376)Bowen & Company, Inc.1985-11-13
CAMBRIDGE MODEL XT1000 (K854283)Cambridge Medical Instruments, Inc.1985-11-13
MECRON UNCEMENTED STRUCTURED STEM HIP (K854191)Mecron Medical Products, Inc.1985-11-13
ANADIAS NASAL SAW BLADES (K854192)Anadias, Inc.1985-11-13
MIDAS REX OPERATING ROOM VISE (K854123)Midas Rex Pneumatic Tools, Inc.1985-11-13
SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (K854327)Concord Laboratories, Inc.1985-11-13
ODAC-ON DEMAND ARALGESIA BY COMPUTER-INFUSION PUMP (K850792)Janssen Pharmaceutica, Inc.1985-11-13
STATLOCK (K854008)Healthtek, Inc.1985-11-13
SANA-LUBE (K853653)Huntington Laboratories, Inc.1985-11-13
THE DEXTRA PRECISION POWER UNIT (K853778)Storz Instrument Co.1985-11-13
LINEAR ARRAY PROBE PLB-310M FOR SAL-32B (K853311)Toshiba Medical Systems1985-11-13
NEEDLE W/STYLET FOR IMPLANTATION (K854238)Microvasive1985-11-13
R.R. PRONTO SIRINGA (K852503)Medical Hospital Equipment1985-11-13
SETMA FHT, MODEL ST 8130 (K854263)Setma, Inc.1985-11-13
SURGILASE 40S (K852470)Surgilase, Inc.1985-11-13
SURGICAL & DENTAL INSTRUMENT (K854146)Baort, Inc.1985-11-13
AQUACEL SURGICAL PREP PADS (K854344)Advanced Ortho-Technology, Inc.1985-11-13
CENTERCOM CONTROL (K853270)Carrom Healthcare, Inc.1985-11-13
THAYER-MARTIN MEDIUM (MOD) (K854275)R. Kent Richards, Inc.1985-11-12
THROMBOPLASTIN-R REAGENT (K853986)American Dade1985-11-12
DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066)Diagnostic Products Corp.1985-11-12
OPHTHALMIC LASER PHOTOCOAGULATOR (K853890)Mira, Inc.1985-11-12
KODAKEKTACHEM DTR MODULE (K854138)Eastman Kodak Company1985-11-12
SIOM (K854343)South West Intl., Inc.1985-11-12
CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR (K852929)Microbix Biosystems, Inc.1985-11-12
CADD-1, MODEL 5100 HF, AMBULATORY INFUSION PUMP (K853584)Deltec Systems, Inc.1985-11-12
HOTIP HEMOSTATIC PROBE (K843628)Trimedyne, Inc.1985-11-12
21 HEMATOLOGY REAGENTS (K853304)In Vitro Diagnostics, Inc.1985-11-12
LEUCO PREP (K854093)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-12
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE (K854244)Keeler Instruments, Inc.1985-11-12
ACE-KYLE DYE INJECTION NEEDLE P/N 14082 (K853604)Today'S Machining & Design, Inc.1985-11-12
MODEL J25-25 WATT CO2 LASER (K851425)Britt Corp., Inc.1985-11-12
THE ULTRA-MATE LENS (K854218)Optical Systems Intl., Inc.1985-11-12
POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO (K854108)Medical Diagnostic Technologies, Inc.1985-11-12
SPAN / AID SYRINGE (K854255)Span-America Medical Systems, Inc.1985-11-12
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT (K852790)Nova Biomedical Corp.1985-11-12
HERPES HOMINUS I-COMPLE FIX ANTIGEN & NEGATIVE CLT (K852931)Microbix Biosystems, Inc.1985-11-12
DART IRON & IRON BINDING CAPACITY REAGENT (K854305)Coulter Electronics, Inc.1985-11-12
NITROGLYCERIN INFUSION SET (K853019)Lyphomed, Inc.1985-11-12
MCGAW/DROP WATCH FLOW MONITOR (K853549)American Mcgaw1985-11-12
KERATOLUX (K854383)Carl Zeiss, Inc.1985-11-12
MICRO THERM MT-500 & MT-600 (K854035)Medequi, Division of King Yip Co., Inc.1985-11-12
FRESENIUS DISPOSABLE BLOOD LINES (K853851)Seratronics, Inc.1985-11-12
MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT (K852932)Microbix Biosystems, Inc.1985-11-12
OPHALMIC LASER PHOTOCOAGULATOR (K854288)Mira, Inc.1985-11-12
VIROGEN ROTATEST SLIDE TEST (K853399)Armkel, LLC1985-11-12
VARICELLA-ZOSTER-COMPLE FIX ANTIGEN AND NEG CONTRO (K852930)Microbix Biosystems, Inc.1985-11-12
MEBIASIS AGAR GEL DIFFUSION KIT (K854230)Lmd Laboratories1985-11-12
KEYMED OFFICE COUCH (K854304)Keymed, Inc.1985-11-12
TECHNA VISION AUTO-PERIMETER (K853290)Techna Vision1985-11-12
IRON (K854298)Boehringer Mannheim Corp.1985-11-12
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Track 1985 automatically

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