Atlas FDA

1987

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

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RecordFirmDate
H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (K873908)Richmond Products, Inc.1987-12-23
BTE HEARING AID OTICON MODEL E39PL (K874381)Oticon Corp.1987-12-23
OCS 100 (OCULAR COMPARATOR SYSTEM) (K874220)Ocular Instruments, Inc.1987-12-23
RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS (K874630)Downs Surgical , Ltd.1987-12-23
WOODLYN CLASSIC REFRACTOR, PHOROPTOR (K874900)Woodlyn, Inc.1987-12-23
OPMI MD SURGICAL MICROSCOPE (K874241)Carl Zeiss, Inc.1987-12-23
BREATHE WITH EEZ (NASAL DILATOR) (K874089)Breathe With Eez Corp.1987-12-23
DAMON D.E.T.E.C.T IMAGE ENHANCER (K874865)Damon Corp.1987-12-23
TILSON TRACH GUARD (K873974)Beevers Mfg. & Supply, Inc.1987-12-22
FRUCTOSAMINE TEST (ROCHE) (K854010)Roche Diagnostic Systems, Inc.1987-12-22
TELESONIC BODY STIMULATOR (K872606)Telesonic, Inc.1987-12-22
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (K871835)Miles Laboratories, Inc.1987-12-22
MODIFIED PALLADIUM SEED MODEL 100 (K874787)Theragenics Corp.1987-12-22
OPHTHALMIC DISPOSABLE BLADES (K874056)Myocure, Inc.1987-12-22
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 (K874705)Em Diagnostic Systems, Inc.1987-12-22
ECMO-TEMP (TM) BLOOD WARMING DEVICE (K873699)Seabrook Medical Systems, Inc.1987-12-22
HVA & HOMOVANILLIC ACID BY HPLC METHOD (K873372)Bio-Rad1987-12-22
WAKO(TM) AUTOKIT LIPASE (K874640)Wako Chemicals USA, Inc.1987-12-22
INORGANIC PHOSPHORUS (K874472)Catachem, Inc.1987-12-22
EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY (K874625)Syva Co.1987-12-22
SEALFLEX MASK (K874746)Engineered Medical Systems1987-12-21
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST (K872628)Ortho Diagnostic Systems, Inc.1987-12-21
CALIBRATION GAS FOR CARBON DIOXIDE MONITOR (K874297)Liquid Air Corp.1987-12-21
RESPIRGARD II NEBULIZER SYSTEM (K874395)Marquest Medical Products, Inc.1987-12-21
BABYFLEX PATIENT CIRCUIT (K874559)Airoflex Medical, Inc.1987-12-21
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) (K874658)Technicon Instruments Corp.1987-12-18
TAKEDA MEDICAL BLOOD PRESSURE METER MODEL TM-2620 (K874339)A&D Engineering, Inc.1987-12-18
MEC-I-TRON, MODEL P-1 (K873190)Meyer Equipment Company, Inc.1987-12-18
MULTICHEM CHLORIDE REAGENT S0933 (K874812)Simmler, Inc.1987-12-18
TDXR DELTA-9-CANNABINOIDS (K874646)Abbott Laboratories1987-12-18
WHITESIDE ORTHOLOC CALCAR REPLACEMENT HIP STEM PRO (K874740)Dow Corning Wright1987-12-18
ENVISAN PASTE (K874553)Marion Laboratories, Inc.1987-12-18
NDNA ANTIBODY TEST KIT (K874191)Lipogen, Inc.1987-12-18
EMIT CONVENIENCE PACK: GENTAMICIN ASSAY (K874703)Syva Co.1987-12-18
MWI 400 WOUND DRESSING (K874470)Med-West, Inc.1987-12-18
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY) (K874603)Ciba Corning Diagnostics Corp.1987-12-18
KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED (K874547)Kirschner Medical Corp.1987-12-18
FUKUDA DENSHI MODEL FCP-231 (K874768)Fukuda Denshi USA, Inc.1987-12-18
PCI MODEL RS100 TELEMETRY MONITOR (K874387)Accucore, Inc.1987-12-18
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 (K874622)Cyberfluor, Inc.1987-12-18
LACTATE DEHYDROGENASE LDH-L (K874848)Tech-Co, Inc.1987-12-18
MAGNESIUM (K874847)Tech-Co, Inc.1987-12-18
HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (K873771)American V. Mueller1987-12-18
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 (K874708)Em Diagnostic Systems, Inc.1987-12-18
IMACK-MB TEST PROCEDURE (MODIFICATION) (K874545)Intl. Immunoassay Laboratories, Inc.1987-12-18
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT (K874281)Medix Biotech, Inc.1987-12-18
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX (K874086)3M Company1987-12-17
NOVA TRANSFER SYSTEM, MODEL XXX (K874448)Nova Technology Corp.1987-12-17
RAYLOR(TM) DRILL STOP (K873692)Cedar Surgical, Inc.1987-12-17
BODYLOG STRESS REDUCTION PACKAGE (K873418)Bodylog, Inc.1987-12-17
RANGE OF CROCODILE ACTION INSTRUMENTS (K873934)Downs Surgical , Ltd.1987-12-17
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM (K873933)Downs Surgical , Ltd.1987-12-17
BIOCHEM 9090 CAPNOGRAPH/SAO2 (K873856)Biochem International, Inc.1987-12-17
AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (K874879)United States Surgical, A Division of Tyco Healthc1987-12-17
ACE CANNULATED SELF-TAPPING CORTICAL BONE SCREW (K874670)Buckman Co., Inc.1987-12-17
MODEL 1740 PERSONAL POCKET PROGRAMMER (K864712)Telectronics, Inc.1987-12-17
PROTECT DROPS/SAME AS K874070 (K874194)John O. Butler1987-12-16
BARD MICROINFUSER I INSULIN INFUSION PUMP (K871807)C.R. Bard, Inc.1987-12-16
INFUSION PUMP MODEL 275 (K872516)Avi, Inc.1987-12-16
INFUSION PUMP MODEL 270 (K872514)Avi, Inc.1987-12-16
INFUSION PUMP MODEL 470 (K872515)Avi, Inc.1987-12-16
ANTI-SHOCK TROUSERS (K873997)Simulaids, Inc.1987-12-15
MONOPOLAR CAUTERY BLADE TIP #TM-1701 (K873653)Arthropedics, Inc.1987-12-15
300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER (K874090)Medac, Inc.1987-12-15
ANGIOSCOPE (K865017)Mansfield Scientific, Inc.1987-12-15
SCHNEIDER-SHILEY ANGIOPORT(TM) PTCA INTRO W/HEMO (K873195)Angiomedics, Inc.1987-12-15
MONOPOLAR CAUTERY CONICAL TIP #TM-1702 (K873654)Arthropedics, Inc.1987-12-15
FITNESS RECUMBENT ERGOMETER, MODEL FT1400 (K872548)Invacare Corp.1987-12-15
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703 (K873655)Arthropedics, Inc.1987-12-15
STRATUM D (K874697)Alternative Design Systems, Inc.1987-12-15
I.M.N. LATEX (K874678)Biokit USA, Inc.1987-12-14
GUAZE SPONGES (K874067)Interpro Intl., Inc.1987-12-14
HI-TOUCH (TM) BRAND SURGICAL GLOVES (K874539)Apex Medical Technologies, Inc.1987-12-14
E600B FOOTSWITCH (K874794)Valleylab, Inc.1987-12-14
DIFFERENTIAL I.M. SCREENING TEST (K873297)Sclavo, Inc.1987-12-14
MODEL V4 AUDIOMETER (K874516)Digital Hearing Systems Corp.1987-12-14
PARAMAX MAGNESIUM REAGENT (K873530)Baxter Healthcare Corp1987-12-14
PARAMAX ISE CHLORIDE CALIBRATOR (K873743)Baxter Healthcare Corp1987-12-14
SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL (K872254)Surgical Laser Technologies, Inc.1987-12-14
MULTI-FUNCTION BLOOD GAS CONTROL (K874408)Bionostics, Inc.1987-12-14
PARAMAX CALCIUM REAGENT (K873519)Baxter Healthcare Corp1987-12-14
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE (K874099)Biopro, Inc.1987-12-14
MEDATRON CUVETTE DISC (K873656)Medatron, Inc.1987-12-14
BIOCHEM 8800 CAPNOMETER (K873959)Biochem International, Inc.1987-12-11
INSTITUTIONAL BILI LIGHT (IBL) (K873700)Physician Engineered Products, Inc.1987-12-11
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM (K872125)C.R. Bard, Inc.1987-12-11
LOVIEL CONDOM (K872861)Lloviel Marketing Corp.1987-12-11
ACE CORTICAL LAG SCREW (K874672)Buckman Co., Inc.1987-12-11
REBUILDER(TM) (K874085)Micromed, Inc.1987-12-11
'E' CUBE AND 'E' PAD (K873916)Richmond Products, Inc.1987-12-11
ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (K873914)Richmond Products, Inc.1987-12-11
FIBERLASE II ND:YAG LASER FOR PULMONARY USE (K872351)Laser Media1987-12-11
TECNOL COMPRESSION KNEE DRESSING (K873368)Tecnol New Jersey Wound Care, Inc.1987-12-11
S-10 TELEPHONIC POLYSOMNOGRAPH (K874257)Telediagnostic Systems, Inc.1987-12-11
POST AURICULAR HEARING AID 46PP-PC SUMMIT (K874707)Richards Medical Co., Inc.1987-12-11
ASCENDING VENTILATOR BELLOWS (K874371)Draeger Medical, Inc.1987-12-11
EUB-410 DIAGNOSTIC ULTRASOUND DEVICE (K871004)Hitachi Medical Corp. of America1987-12-11
ACE BONE SCREW NUT (K874669)Buckman Co., Inc.1987-12-11
THERMOWRAP, A/K/A/, THERMAL WRAP (K873254)Family Sun Tanning1987-12-11
IVAC(R) DUAL RATE SET - MODEL C50066 (K873938)Y1987-12-11
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Every clearance here is in the API, with alerts when new ones post.