Atlas FDA

1986

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

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RecordFirmDate
R1596 POWERED EXERCISE EQUIPMENT (K861347)Tri W-G, Inc.1986-05-02
HOOK SCISSOR (K854896)Euro-Med Intl.1986-05-02
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG (K861434)Churchill Corp.1986-05-01
SPECTRO VWF (K861159)Ramco Laboratories, Inc.1986-05-01
CORDOT R (K854618)Cordis Corp.1986-05-01
VMA BY HPLC TEST (VANILMANDELIC ACID) (K861010)Bio-Rad1986-05-01
FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI (K853988)Foran Industries, Inc.1986-05-01
GREEN-LINE BIPOLAR COAGULATION UNIT (K860479)Grieshaber & Co.1986-05-01
INFAGUARD TM (K854705)Lifewatch Systems, Inc.1986-05-01
DCI MODEL EP-2 CLINICAL STIMULATOR (K854196)Digital Cardiovascular Instruments, Inc.1986-05-01
ELECTROCARDIOGRAPH CONTINUOUS MONITOR (K860457)Oxford Medilog, Inc.1986-04-30
PAINBLOCKER WA5000 (K854334)Wallach Surgical Devices, Inc.1986-04-30
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH (K861084)Coors Biomedical Co.1986-04-30
HEARTSTART 2000 (K860676)First Medical Devices Corp.1986-04-30
KOI PACHYMETER (K843247)Koi, Inc.1986-04-30
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST (K860470)Del Mar Avionics1986-04-30
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH (K861083)Coors Biomedical Co.1986-04-30
ETP 180 CARDIAC PACEMAKER (EXTERNAL) (K860551)Biotronics Corp.1986-04-30
BISCO'S PORCELAIN VENEER SYSTEM (K861148)Bisco, Inc.1986-04-30
DIALET LANCING DEVICE (K861265)Home Diagnostics, Inc.1986-04-30
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER (K860471)Del Mar Avionics1986-04-30
ISOTRAK AMYLASE ISOENZYME CONTROL SET (K861329)Behring Diagnostics, Inc.1986-04-30
ZEISS VOICE CONTROL SYSTEM FOR OPMI'S (K860811)Carl Zeiss, Inc.1986-04-30
FACEGLOV,ANESTHETIC GAS MASK (K860686)Loran , Ltd.1986-04-30
STERILE STOCKINETTE W/ANTIMICROBIAL AGENT (K861196)Deroyal Industries, Inc.1986-04-30
MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER (K861176)Intermedics, Inc.1986-04-29
CARDIO-COOL (K860523)Bio-Vascular, Inc.1986-04-29
SUBCLAVIAN INTRODUCER SET (K860898)Infusaid Corp.1986-04-29
SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER (K860362)Travenol Laboratories, S.A.1986-04-29
NEONATAL UNILET (K861243)Ulster Scientific, Inc.1986-04-29
BARD PARKER PERFUSION CATHETER (K855201)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-04-29
LEE ELECTRONICS PAL (K854637)Lee Electronics1986-04-29
PERCUTANEOUS CATHETERS (K861008)Micor, Inc.1986-04-29
TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT (K860984)Hybritech, Inc.1986-04-29
SPACELABS MEDICAL WORKSTATION (K860834)Spacelabs, Inc.1986-04-29
SARNS OXYGENATOR SYSTEM (K860539)3M Health Care, Sarns1986-04-29
AP REAGENT CARTRIDGE (K861284)Hi Chem, Inc.1986-04-28
MULTI-SPIKE (K861203)Surgeon Surgical Instrumentation, Inc.1986-04-28
AST REAGENT CARTRIDGE (K861283)Hi Chem, Inc.1986-04-28
T-VAC PLEURAL DRAINAGE UNIT, 7800 SERIES (K861025)Boehringer Laboratories1986-04-28
ULTRA-VIOLET GOGGLETS (K861333)Health Saver Products1986-04-28
IMMPULSE FREE ESTRIOL ASSAY REAGENTS (K860900)Sclavo, Inc.1986-04-28
HI CHEM DIAGNOSTICS LDL REAGENT CARTRIDGE (K861419)Hi Chem, Inc.1986-04-28
ALT REAGENT CARTRIDGE (PRODUCT NO. 88210) (K861231)Hi Chem, Inc.1986-04-28
QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID (K861448)Quantimetrix Medical Industries1986-04-28
PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3 (K860287)Healthcheck Corp.1986-04-28
GUIDE WIRE INTRODUCER (K860841)Target Therapeutics1986-04-28
VARIABLE HIGH FLOW DOWNS CPAP GENERATOR (K861104)Med Air Technology, Inc.1986-04-28
TSHK-NN RIA KIT (K860824)Cis-Us, Inc.1986-04-28
CHLAMYSET ANTIGEN (K853401)Orion Corp.1986-04-28
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR (K854370)Nihon Kohden America, Inc.1986-04-28
P.O. VOX (K860993)Bloomfield Research and Development, Inc.1986-04-25
MONITRAL S (K861230)Hospal Medical Corp.1986-04-25
QUIDEL ALLERGY SCREEN (K861171)Quidel Corp.1986-04-25
IAP PLATE TEST (K861336)Scientific Sales Intl., Inc.1986-04-25
IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST (K861167)Atlantic Antibodies1986-04-25
DB PRECISION IMPLANT SYSTEM, 2000 SERIES (K860982)Driskell Bioengineering1986-04-25
GLASIONOMER BASE CEMENT (K861005)Shofu Dental Corp.1986-04-25
REPLACEMENT HOSES (K861405)Micro-Aire Surgical Instruments, Inc.1986-04-25
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS (K861184)Pharmacia, Inc.1986-04-25
TAN MATE HOME TANNING UNIT (K861107)Specialty Engineering, Inc.1986-04-25
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET (K861413)Medical Analysis Systems, Inc.1986-04-24
GLUCOSE (HEXOKINASE) REAGENT SET (K861311)Sterling Diagnostics, Inc.1986-04-24
EBV(EPSTEIN-BARR VIRUS) TEST KIT (K854207)Immuno-Diagnostic Products, Inc.1986-04-24
ENZYMATIC BUN REAGENT (K860716)Trace Scientific , Ltd.1986-04-24
MMG EXTERNAL FEMALE CATHETERS (K854821)Medical Technologies of Georgia1986-04-24
SHARPLAN MODEL 1020 CO2 SURGICAL LASER SYSTEM (K860087)Sharplan Lasers, Inc.1986-04-24
AEROSOL ONE (K852622)Ashai Co. , Ltd.1986-04-24
MMS T4 RIA KIT (K861320)Micromedic Systems1986-04-24
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K861057)Precision-Cosmet Co., Inc.1986-04-24
BETA QUIK STICK (K860965)Pacific Biotech, Inc.1986-04-24
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK (K861061)Em Diagnostic Systems, Inc.1986-04-24
LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. (K860713)Catachem, Inc.1986-04-24
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS (K861141)CooperVision, Inc.1986-04-24
CLEARBLUE PREGNANCY TESTING KIT (K861168)Unipath , Ltd.1986-04-24
BIO-PEN CALCULATOR (K860205)Oculab, Inc.1986-04-24
CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE (K860733)Trace Scientific , Ltd.1986-04-24
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT (K860335)Diagnostic Products Corp.1986-04-24
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 (K861055)Em Diagnostic Systems, Inc.1986-04-24
ALP (ALKALINE PHOSPHATASE) REAGENT (K860715)Trace Scientific , Ltd.1986-04-24
GLUCOSE OXIDASE PROCEDURE (K861204)Data Medical Associates, Inc.1986-04-24
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST (K861221)Em Diagnostic Systems, Inc.1986-04-24
ULTROSPEC K KINETICS SPECTROPHOTOMETER (K861194)Lkb Instruments, Inc.1986-04-24
NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY (K861328)Belmont Equipment Corp.1986-04-24
SERUM CHOLINESTERASE REAGENT SET (K860350)Sterling Diagnostics, Inc.1986-04-24
DISPOSABLE SYRINGES AND HYPODERMIC NEEDLES (K861153)Exel Intl.1986-04-23
SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ (K854591)Philips Medical Systems, Inc.1986-04-23
NO FLOSS FLOSSER (K854326)Rgm Assoc.1986-04-23
HANDHELD DOPLER/PEN TRANSDUCER 3MHZ (K854590)Philips Medical Systems, Inc.1986-04-23
FISCH DRILL IRRIGATOR (K861298)Jedmed Instrument Co.1986-04-23
VAN-TEC DISPOSABLE FLEXIBLE ENDOSCOPE (K860771)Van-Tec, Inc.1986-04-23
5000 SERIES ECG ELECTRODES (K854757)Alternative Design Systems, Inc.1986-04-23
MODEL ST HEARING AID (K861254)Fine-Tune1986-04-23
URDYN 5000 (UROFLOWMETER) (K860368)Dantec Electronics, Inc.1986-04-23
CATHETER INTRODUCER (K860958)Target Therapeutics1986-04-23
MODIFIED CHERNE CAD DETECTOR (K860015)Cherne Industries, Inc.1986-04-23
MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT (K861045)Sharplan Industries, Inc.1986-04-23
DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (K860546)Pacesetter Systems1986-04-23
SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA (K861174)Shiley, Inc.1986-04-23
MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY (K860273)Britt Corp., Inc.1986-04-23
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Track 1986 automatically

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