Atlas FDA

1987

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

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RecordFirmDate
IODOSORB POWDER (K870559)Perstorp AB C/O Robert Joel Slomoff1987-03-20
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (K870117)Pro-Lab, Inc.1987-03-20
TARGET THERAPEUTICS TAPER GUIDE WIRE (K864316)Target Therapeutics1987-03-20
ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 (K870824)Pacesetter Systems1987-03-20
RICHARDS EXTERNAL FIXATION SYSTEM (K870961)Richards Medical Co., Inc.1987-03-19
CENTRIPREP CONCENTRATOR (K870690)Amicon, Inc.1987-03-19
STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. (K870158)American Dade1987-03-19
ALANINE TRANSAMINASE (ALT) TEST KIT (K870879)Genetic Systems Corp.1987-03-19
COAT-A-COUNT PCP KIT NUMBER TKPC1 (K870875)Diagnostic Products Corp.1987-03-19
COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 (K870740)Diagnostic Products Corp.1987-03-19
COAT-A-COUNT METHADONE TKMD1 (K870937)Diagnostic Products Corp.1987-03-19
STEADY RESIN (K870908)Great Lakes Orthodontics, Ltd.1987-03-19
ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR (K870673)E.I. Dupont DE Nemours & Co., Inc.1987-03-19
EASY-TEST URIC ACID (URIC) #16606 (K870868)Em Diagnostic Systems, Inc.1987-03-19
CANDIDATE(R) SUPER (K863499)Mercia Diagnostics , Ltd.1987-03-19
ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 (K864500)Analytic Technology1987-03-19
DR.BRUNO LANGE MINI-HBA1 PHOTOMETER (K865055)Diversa Corp.1987-03-19
COAT-A-COUNT METHAQUALONE TKMQ1 (K870935)Diagnostic Products Corp.1987-03-19
CONTRASYL IMPRESSION MATERIAL (K870011)Contracap1987-03-19
THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT (K863913)Diagnostic Products Corp.1987-03-19
SEWON DENTAL FLOSSER (K870996)Sewon Industry1987-03-19
COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5 (K870936)Diagnostic Products Corp.1987-03-19
SOFT EAR STETHOSCOPE (K870600)Kalajian Ent.1987-03-19
MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 (K870809)Adept-Med Intl., Inc.1987-03-19
T-TUBE INSERTER (K870978)Sur-Med Instruments, Inc.1987-03-19
TRU-STIM MUSCLE STIMULATOR (K870774)Briefcase, Inc.1987-03-18
SUPER SCISSORS (K870763)Treace Medical, Inc.1987-03-18
BUR BRUSH (K870760)Treace Medical, Inc.1987-03-18
SCHUKNECHT WIRE CUTTING SCISSORS (K870764)Treace Medical, Inc.1987-03-18
BONDEX* GLASS IONOMER CEMENT (K870211)Johnson & Johnson Professionals, Inc.1987-03-18
O.B. SLENDER REGULAR TAMPON (K870539)Personal Products Co.1987-03-18
ULTRA-LUX LIGHT SOURCE (K870898)Medline Industries, Inc.1987-03-18
A.T.S. 1500 TOURNIQUET (K870784)Aspen Laboratories, Inc.1987-03-18
THE EXPERIMENTAL (K864455)Martin H. Kaufmann1987-03-18
AARON C SIZE(TM) HIGH TEMPERATURE CAUTERY (K870397)Sunkey Medical Manufacturing, Inc.1987-03-18
NOTCH-NEEDLE, WESCOTT STYLE (K870896)Ocean Medical Products, Ltd.1987-03-18
PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK (K870374)Daig Corp.1987-03-18
COAG-A-MATE(R) XC (K870960)Organon Teknika Corp.1987-03-17
AZTREONAM 30 MCG SUSCEPTIBILITY DISK (K870870)Organon Teknika Corp.1987-03-17
NORFLOXACIN 10 MCG SENSITIVITY DISKS (K870348)Difco Laboratories, Inc.1987-03-17
ACCUPEN(R) (K870078)Ulster Scientific, Inc.1987-03-17
PAD, BED LINEN PROTECTIVE (K870925)Quality Disposables, Inc.1987-03-17
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK (K864848)Organon Teknika Corp.1987-03-17
RNP EIA DIAGNOSTIC KIT (K870457)Biohytech International, Inc.1987-03-17
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE (K870720)American Pharmaseal Div. Ahsc1987-03-17
VETA/VENTED ESOPHAGEAL TUBE AIRWAY (K864200)Cranco Co.1987-03-17
DIAMOND MEDICAL, INC., MODEL DM 700 (K863298)Diamond Medical, Inc.1987-03-17
DNP EIA DIAGNOSTIC KIT (K870456)Biohytech International, Inc.1987-03-17
T-CONNECTORS 014500/014501/014502/014503-120 (K870912)Clinical Connections, Inc.1987-03-17
KEELER PULSAIR NON CONTACT TONOMETER (K870750)Keeler Instruments, Inc.1987-03-17
SM EIA DIAGNOSTIC KIT (K870455)Biohytech International, Inc.1987-03-17
THE (CROM) TESTER (K870767)Twin City Surgical, Inc.1987-03-17
NEU-PULS(TENS) MODEL #295 (K870583)Oms Medico, Inc.1987-03-17
JIMMY JOHN III, COLONIC IRRIGATION SYSTEM (K870376)Colon Therapeutics1987-03-17
BODY WATCH BODY COMPOSITION ANALYZER MODEL 2010 (K863833)Body Watch, Inc.1987-03-17
PERSONAL INFUSION PUMP (K864276)Bionica, Inc.1987-03-17
SS-DNA EIA DIAGNOSTIC KIT (K870452)Biohytech International, Inc.1987-03-17
ALLERG*ENS ENZYME IMMUNOASSAY KIT (K864696)Dexall Biomedical Labs, Inc.1987-03-17
DACOMED PENILE PROSTHESIS SIZER (K870320)Dacomed Corp.1987-03-17
HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI (K864265)Dial Medical of Florida, Inc.1987-03-17
WARM WEIGH MODEL N-10 INFANT SCALE (K870888)Air-Shields, Inc.1987-03-17
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (K870233)Abbott Diagnostics1987-03-17
INJECTION SITE #014456-120 (K870913)Clinical Connections, Inc.1987-03-17
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. (K870940)Travenol Laboratories, S.A.1987-03-17
NORFLOXACIN 10 MCG SENSI DISC (K864756)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-17
MYA-1 AND MYT-1 MYELOGRAM TRAY (K870418)North Coast Medi-Tek1987-03-17
IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (K870089)Microscan Div. Baxter Healthcare Corp.1987-03-17
UNI-PULS(TENS) MODEL #292 (K865063)Oms Medico, Inc.1987-03-17
DELTATRAC(TM) METABOLIC MONITOR (K864603)Datex Division Instrumentarium Corp.1987-03-17
HISTONES EIA DIAGNOSTIC KIT (K870458)Biohytech International, Inc.1987-03-17
MODIFIED JIMMY JOHN III (K870127)Colon Therapeutics1987-03-17
LIFEWATCH(R) PORTABLE MONITORING SYSTEM (K864419)Lifewatch Systems, Inc.1987-03-16
PFLEX EM(TM) (EXERCISE MONITOR) (K864719)Health Products, Inc.1987-03-16
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD (K870363)Trace Scientific , Ltd.1987-03-16
CYTOSCAN (K864955)Image Recognition Systems , Ltd.1987-03-16
ABUSCREEN (R) EIA CANNABINOIDS (K870377)Roche Diagnostic Systems, Inc.1987-03-16
ACCELOGRAPH (K870619)Biometer Intl. A/S1987-03-16
COCAINE METABOLITE ROCHE(R) EIA (K863843)Roche Diagnostic Systems, Inc.1987-03-16
STAVIP 3000 (K864436)Roseburg SA1987-03-16
ABUSCREEN (R) EIA BARBITURATE (K870378)Roche Diagnostic Systems, Inc.1987-03-16
CHART-TYPE MICRO HEMATOCRIT TUBE READER (K870511)Norfolk Scientific, Inc.1987-03-16
MOBILIMB HAND EXERCISER (K870402)Biodynamic Technologies, Inc.1987-03-16
HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER (K870027)Salter Labs1987-03-16
ARIES TAPERED SHEATH (K870189)Aries Medical, Inc.1987-03-16
BODYSCAN (K870818)Siemens Gammasonics, Inc.1987-03-16
(MERIFLUOR)TM-CRYPTOSPORIDIUM (K870171)Meridian Diagnostics, Inc.1987-03-16
MORPHINE ROCHE (R) EIA TEST (K864168)Roche Diagnostic Systems, Inc.1987-03-16
HORIZON 1100 CARDIAC MONITOR (K864843)Mennen Medical, Inc.1987-03-16
RESUBMISSION OF THE KLEERZIT REAGENT (K864866)Advanced Biomedical Methods, Inc.1987-03-16
RMI VENOUS DRAINAGE CANNULA (K870109)Research Medical, Inc.1987-03-16
IQ FTI IMMUNOASSAY (K865104)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-03-16
ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM (K864374)Sherwood Medical Co.1987-03-16
CHALLENGER DOSIMETER (K870755)Salter Labs1987-03-16
MEVACHECK (K864910)Magus Microcontrollers, Inc.1987-03-16
GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA (K870507)Research Medical, Inc.1987-03-16
VISION(TM) CRP (K864131)Abbott Laboratories1987-03-16
AC ADAPTER ACCESSORY, PRODUCT CODE 600123A (K870768)Deltec Systems, Inc.1987-03-13
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER (K864872)Medica Corp.1987-03-13
INTERMATE(TM) (K870242)Infusion Systems Corp.1987-03-13
SCHULTZ MP COMPONENT PUNCH (K870846)Warsaw Orthopedic, Inc.1987-03-13
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Track 1987 automatically

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