Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
NOVA STREP A (K873784)Synbiotics Corp.1987-11-12
MODEL A-72, BEHIND-THE-EAR HEARING AID (K874325)Audiotone, Inc.1987-11-12
CLEARFIL PORCELAIN REPAIR SYSTEM (K873886)Kuraray Co.1987-11-12
DIAMOND-LUSTER DENTAL POLISHING PASTE (K873686)Scientific Pharmaceuticals, Inc.1987-11-12
TUBING, POLYETHYLENE (K873597)Coeur Laboratories, Inc.1987-11-12
MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2 (K873246)Coherent Medical Group1987-11-10
EPI-LOCK T.M. PRIMADERM (K874291)Derma-Lock Medical Corp.1987-11-10
EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 (K874101)Em Diagnostic Systems, Inc.1987-11-09
ANTI-INFECTION SHIELD (K872935)Stackhouse Assoc.1987-11-09
D.R.P. THREE STEP WOUND DRESSING (K871327)Bioderm, Inc.1987-11-09
LIFE-SPAN CABLE (K873361)Chemfet Corp.1987-11-09
IV-PUSH, CONSTANT INFUSION PUMP (K874454)Medical Products Search, Inc.1987-11-06
DIGICELL 300 SYSTEM (K873271)Contraves Medical Instruments, Inc.1987-11-06
SPECIALTY MEDIA (K873259)Central Media1987-11-06
LIGHT-SPOT FIBEROPTIC LASER HANDPIECE (K873664)Laserguide1987-11-06
HUMID-VENT(R) MINI (K873767)Gibeck Respiration1987-11-06
EASY-TEST CREATININE (CREA) ITEM NO. 19009 (K874088)Em Diagnostic Systems, Inc.1987-11-06
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER (K873923)American Bentley1987-11-06
QUAD PLATE (4 DIFFERENT MEDIA) (K874344)Lakewood Biochemical Co., Inc.1987-11-06
AESTHESIOMETER (K874300)Orthopedic Systems, Inc.1987-11-06
HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (K874404)Mallinckrodt Critical Care1987-11-06
HAMILTON-THORN MOTILITY ANALYZER HTM-2000 (K873172)Hamilton Thorne Research1987-11-06
DIGICELL 500 (K873252)Contraves Medical Instruments, Inc.1987-11-06
LIGHT-TOUCH FIBEROPTIC MICROCONTACT PROBE (K873571)Laserguide1987-11-06
AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE (K873359)American Pharmaseal Div. Ahsc1987-11-06
LEVTECH CLAMP APPLIER (K874023)Levtech, Inc.1987-11-06
MODEL 7000 COMBINATION END TIDAL & PULSE OXIMETRY (K874036)Novametrix Medical Systems, Inc.1987-11-06
SARNS CARDIOPLEGIA/VENT CATHETERS (K873212)3M Health Care, Sarns1987-11-06
HR(TM) NEEDLE AND SYRINGE (K874372)Icu Medical, Inc.1987-11-06
CORYNEBACTERIA ISOLATION MEDIA (K873260)Central Media1987-11-06
NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260 (K873149)Novametrix Medical Systems, Inc.1987-11-06
GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. (K873257)Central Media1987-11-06
MODEL 410 DENTAL X-RAY FILM PROCESSORS (K874118)Dent-X Co.1987-11-06
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER (K873423)Johnson & Johnson Professionals, Inc.1987-11-06
PRESSURE BARRIER KIT CAT. NO. PBK-3 (K873802)American Omni Medical, Inc.1987-11-06
STAPHYLASE TEST (K874303)Oxoid U.S.A., Inc.1987-11-06
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD (K870885)Medtronic Vascular1987-11-06
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 (K874345)Lakewood Biochemical Co., Inc.1987-11-06
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM (K873745)Augustine Medical, Inc.1987-11-06
GENESIS II (K871697)Biosound, Inc.1987-11-06
LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (K873461)Mallinckrodt Critical Care1987-11-06
SARNS WARMER, PART #164975 AND #164980 (K873813)3M Health Care, Sarns1987-11-06
BONE MARROW COLLECTION KIT AND STAND (K871198)Baxter Healthcare Corp1987-11-06
M300 MONITOR/CONTROLLER T500 TREADMILL (K873774)Burdick Corp.1987-11-06
STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA (K873258)Central Media1987-11-06
EXCEL PULSED IRRIGATION/SUCTION SYSTEM (K873466)Stryker Corp.1987-11-06
MICRO-COUNT DIFFHE (K873256)Toni Diagnostics, Inc.1987-11-06
EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 (K874102)Em Diagnostic Systems, Inc.1987-11-05
CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE (K873894)Travenol Laboratories, S.A.1987-11-05
VALLEYLAB MODEL IV7200 INFUSION PUMP (K873161)Valleylab, Inc.1987-11-05
PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (K873610)American Omni Medical, Inc.1987-11-05
WAKO(TM) AUTOKIT CK-NAC (K873201)Wako Chemicals USA, Inc.1987-11-05
SKINLESS-SKIN, PINK TINT (CONDOM) (K872812)Okamoto USA, Inc.1987-11-05
SKINLESS SKIN-HARMONY CONDOMS (K872664)Okamoto USA, Inc.1987-11-05
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE (K874117)Medtronic Vascular1987-11-05
DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 (K873311)Dale Medical Products, Inc.1987-11-05
AMERLITE TT4 ASSAY (240/480/144 TEST KITS) (K873976)Amersham Corp.1987-11-05
TITAN GEL REP CPK-12 HV (K874146)Helena Laboratories1987-11-05
FLEXIFLO COMPANION ENTERAL NUTRITION PUMP (K873119)Frantz Medical Development, Ltd.1987-11-05
ELECTROMEDICS D1079E (K873561)Electromedics, Inc.1987-11-05
TOTAL IGE FAST (TM) TEST PACKAGE (K873998)3M Company1987-11-04
THE EXPERT MODELS RTS 2000 AND RTS 2000H (K862947)Ocg Technology, Inc.1987-11-04
STAND. CLEAR VINYL DISPOSABLE ECG ELECT.(597 ADHE) (K872869)Labeltape Meditect, Inc.1987-11-04
EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 (K874153)Em Diagnostic Systems, Inc.1987-11-04
EPICARIDA, LE (K872837)Medicomp, Inc.1987-11-04
TITAN GEL REP CPK/LDH ISOENZYME CONTROL (K874141)Helena Laboratories1987-11-04
AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT (K873064)Amtec Diagnostics International, Inc.1987-11-04
IMMUSTRIP(TM) SM ELISA TEST SYSTEM (K873741)Immunomedics, Inc.1987-11-04
PROLOG MP PULSE GENERATORS 658K AND 658T (K872779)Pacesetter Systems1987-11-04
PROJECT 300 MICROASSAY BP-12, EIA MINILAB (K873451)Awareness Technology, Inc.1987-11-04
ECG BASED MEDIA (K873267)Central Media1987-11-04
FALSE RAGWEED ALLERGEN DISC (K874149)Incstar Corp.1987-11-04
PREVENTETTE (CONDOM) (K872619)Reb Enterprises, Inc.1987-11-04
ACTINOMYCETE DIFFERENTIAL MEDIA (K873270)Central Media1987-11-04
DYNABEADS HLA CELL PREP II ISOLATION PRODUCT (K873185)Dynal Biotech, Inc.1987-11-04
SHOE COVERS (K874064)Interpro Intl., Inc.1987-11-04
JOHNSON GRASS ALLERGEN DISC (K874150)Incstar Corp.1987-11-04
NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) (K874115)Sigma Diagnostics, Inc.1987-11-04
MEDIX BIOTECH FERRITIN ENZYME IMMUNOASSAY TEST KIT (K873730)Medix Biotech, Inc.1987-11-04
SYNTRON BIORESEARCH U-TEST PREGNANCY TEST (K874248)Syntron Bioresearch, Inc.1987-11-04
MYCOLOGICAL MEDIA (K873269)Central Media1987-11-04
GIANT RAGWEED ALLERGEN DISC (K873969)Incstar Corp.1987-11-04
DART (R) ELECTROLYTE REAGENT SYSTEM (K874185)Coulter Electronics, Inc.1987-11-04
LAPAROTOMY SPONGES (K874065)Interpro Intl., Inc.1987-11-04
MUELLER HINTON MEDIA (K873268)Central Media1987-11-04
PACESTART (K872778)Pacific Rim Engineering & Mfg.1987-11-04
SURGICAL CAPS (K874066)Interpro Intl., Inc.1987-11-04
HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (K864294)Smith & Nephew, Inc.1987-11-04
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (K872766)Telectronics, Inc.1987-11-04
1205 BETAPLATE LIQUID SCINTILLATION COUNTER (K874094)Lkb Instruments, Inc.1987-11-04
MODEL 78576A PAPER CHART RECORDER (K872822)Hewlett-Packard Co.1987-11-04
BLOOD NEEDLE HOLDER (K873569)Sage Products, Inc.1987-11-03
PHARMACIA DELTEC SUBCUTANEOUS INFUSION SET (K873885)Pharmacia Deltec, Inc.1987-11-03
THERMOCOUPLE ADAPTER (K873833)Mallinckrodt Critical Care1987-11-03
TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. (K874140)Helena Laboratories1987-11-03
DYNATECH MR 300 MANUAL MICROELISA (K874244)Dynatech Laboratories, Inc.1987-11-03
CANNABINOID ENZYME IMMUNOASSAY KIT (K872882)General Diagnostics1987-11-03
ANATOMIC TOTAL HIP (K874229)Zimmer, Inc.1987-11-03
3 RING ATTACHMENT FOR SYRINGES (K873709)Condor Medical1987-11-03
TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 (K874061)Medix Biotech, Inc.1987-11-03
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Track 1987 automatically

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